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Clinical Study Efficacy and Safety of Ashwagandha (Withania somnifera) Root Extract in Improving Sexual Function in Women: A Pilot Study

  • D.Y.Patil University School of Medicine, Navi Mumbai, India

Abstract and Figures

Background. Many women experience sexual dysfunction where there are orgasm disorders and sexual difficulties. Ashwagandha (Withania somnifera) is a herb known to improve the body's physical and psychological condition. Objective. The purpose of the study was to determine the efficacy and safety of a high-concentration ashwagandha root extract (HCARE) supplementation for improving sexual function in healthy females. Methods. In this pilot study, 50 study subjects were randomized to either (i) HCARE-treated group or (ii) placebo-(starch-) treated group. The subjects consumed either HCARE or placebo capsules of 300mg twice daily for 8 weeks. Sexual function was assessed using two psychometric scales, the Female Sexual Function Index (FSFI) Questionnaire and the Female Sexual Distress Scale (FSDS), and by the number of total and successful sexual encounters. Results. The analysis indicates that treatment with HCARE leads to significantly higher improvement, relative to placebo, in the FSFI Total score (í µí± < 0.001), FSFI domain score for " arousal " (í µí± < 0.001), " lubrication " (í µí± < 0.001), " orgasm " (í µí± = 0.004), and " satisfaction " (í µí± < 0.001), and also FSDS score (í µí± < 0.001) and the number of successful sexual encounters (í µí± < 0.001) at the end of the treatment. Conclusions. This study demonstrated that oral administration of HCARE may improve sexual function in healthy women. The present study is registered in the Clinical Trial Registry, Government of India, with a number CTRI/2015/07/006045.
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Clinical Study
Efficacy and Safety of Ashwagandha (Withania somnifera) Root
Extract in Improving Sexual Function in Women: A Pilot Study
Swati Dongre,1Deepak Langade,2and Sauvik Bhattacharyya3
1Trupti Hospital and Santati Fertility Center, Cosmos Paradise, Pokhran Road 1, Link Road, ane, Maharashtra 400 606, India
2Department of Pharmacology, BVDU Dental College & Hospital, Sector 7, C.B.D., Belpada, Navi Mumbai,
Maharashtra 400 614, India
3Department of Pharmaceutical Technology, NSHM Knowledge Campus, 124 B.L. Saha Road, Kolkata 700053, India
Correspondence should be addressed to Deepak Langade;
Received  June ; Revised  August ; Accepted  September 
Academic Editor: Seiichi Saito
Copyright ©  Swati Dongre et al. is is an open access article distributed under the Creative Commons Attribution License,
which permits unrestricted use, distribution, and reproduction in any medium, provided the original work is properly cited.
Background. Many women experience sexual dysfunction where there are orgasm disorders and sexual diculties. Ashwagandha
(Withania somnifera) is a herb known to improve the body’s physical and psychological condition. Objective. e purpose of
the study was to determine the ecacy and safety of a high-concentration ashwagandha root extract (HCARE) supplementation
for improving sexual function in healthy females. Methods. Inthispilotstudy,studysubjectswererandomizedtoeither(i)
HCARE-treated group or (ii) placebo- (starch-) treated group. e subjects consumed either HCARE or placebo capsules of mg
twice daily for  weeks. Sexual function was assessed using two psychometric scales, the Female Sexual Function Index (FSFI)
Questionnaire and the Female Sexual Distress Scale (FSDS), and by the number of total and successful sexual encounters. Results.
e analysis indicates that treatment with HCARE leads to signicantly higher improvement, relative to placebo, in the FSFI Total
score (𝑝 < 0.001), FSFI domain score for “arousal” (𝑝 < 0.001), “lubrication” (𝑝 < 0.001), “orgasm” (𝑝 = 0.004), and “satisfaction”
(𝑝 < 0.001),andalsoFSDSscore(𝑝 < 0.001) and the number of successful sexual encounters (𝑝 < 0.001)attheendofthetreatment.
Conclusions. is study demonstrated that oral administration of HCARE may improve sexual function in healthy women. e
present study is registered in the Clinical Trial Registry, Government of India, with a number CTRI///.
1. Introduction
In female sexual dysfunction (FSD), women could have
female sexual arousal disorder (FSAD), female orgasmic dis-
order (FOD), or hypoactive sexual desire disorder (HSDD).
Some women may have combined genital and subjective
arousal disorder or isolated genital sexual arousal disorder [].
ese disorders result in reduced libido, dryness in vagina,
reduced genital perception, reduced arousal, pain during
intercourse, and problems to achieve orgasm and are majorly
due to neurovascular, hormonal, or psychogenic manifesta-
tions [, ]. It has been observed that women with sexual
problems oen turn to alternative therapies and herbal
adaptogens as a remedy for diminished sexual desire.
Ashwagandha (Withania somnifera)iswidelyutilizedin
Ayurved a , a traditional system of medicine in India, and is
deemed an “adaptogen,” a herb that protects the body from
stress and helps the body address the eects of stress. Ashwa-
gandha has been shown to decrease cortisol levels in persons
under chronic stress, restore healthy adrenal function, and
normalize the sympathetic nervous system [, ]. Ashwa-
gandha root extract is used to treat sexual weakness, erectile
dysfunction, and performance anxiety in men and has been
advocated to ameliorate diminished sexual desire in women
where a depleted nervous system is playing a role.
e contribution of this research is to examine the hypo-
thesis that consumption of a high-concentration ashwagandha
Hindawi Publishing Corporation
BioMed Research International
Volume 2015, Article ID 284154, 9 pages
BioMed Research International
root extract (HCARE) may reduce FSD. ere are two routes
through which this hypothesis may hold. e rst route lies in
ashwagandhas antistress eect. Chronic stress, experienced
oen in modern life, may lead to sexual dysfunction in
females. A number of literatures have reported the cooc-
currence of depression, anxiety, and sexual dysfunction [–
]. It has been found that under chronic stress women
are less motivated and desirous toward sexual activities.
Moreover, excessive stress along with anxiety and fatigue
leads to sexual arousal diculties and vaginal pain []. A
number of studies have conrmed the antistress eect of
ashwagandha [, , ]. Stress is associated with increase in
cortisol in the blood, which in turn is associated with gonadal
and sexual dysfunction []. Ashwagandha reduces serum
cortisol level, as has been reported in various clinical studies
[, , ]. e second route to the hypothesis that HCARE
consumption may reduce FSD lies in ashwagandha osetting
androgen deciency syndrome, which is seen as contributing
to a lack of sexual desire in some women. Testosterone levels
level may be associated with FSD []. Ashwagandha has tra-
ditionally been used to treat weakness, erectile dysfunction,
performance anxiety in men, and diminished sexual desire
in both men and women [–]. e herb has been found in
men to increase serum testosterone level, decrease follicle-
stimulating hormone (FSH) level, and increase luteinizing
hormone (LH) production [, ]. Ashwagandha may sim-
ilarly increase testosterone in women and oset androgen
deciency syndrome.
is pilot study is randomized, double blind, and
placebo-controlled and aims to assess the ecacy and safety
of HCARE in improving FSDS and FSFI in otherwise healthy
females with sexual dysfunction and arousal disorder. is is
the rst study to evaluate the eectiveness of ashwagandha
root extract to address FSD.
2. Materials and Methods
2.1. Study Material. e HCARE used in the present study
was KSM- ashwagandha, a water-based extract made by
Ixoreal Biomed of Los Angeles, California. We chose this
extract because our hypotheses center on treatment with
HCARE and KSM- is currently the highest concentration
extract (as assessed by withanolide fraction) available on
the market. e use of a publicly available extract like this
increases replicability of our procedures by other researchers.
Starch powder was used as placebo. We provided the extract
and the placebo powder to a local laboratory which then put
these into hard gelatin capsules of identical size, shape, color,
and texture.
2.2. HPLC Conditions. e HPLC analysis of ashwagandha
root extract was done by Advanced Analytical Testing Labo-
ratories, North Brunswick, New Jersey. e analysis of with-
anolides in HCARE was performed on a Waters  HPLC
system, using a SunFire C column of dimensions  ×
. mm, and 𝜇m. e ow rate was mL/min. e solvent
system is based on methanol : water ( : ). At the end of the
run, the column was ushed with % methanol for  min.
e column temperature was C and the injection volume
was  𝜇L.
Six withanolides were used as marker compounds in this
study.  mg of a particular marker compound was accurately
weighed and transferred into a  mL volumetric ask.  mL
of HPLC grade methanol was poured into this volumetric
ask and the solution was sonicated for  min or until the
compound dissolves completely. From this resultant solution,
 mL,  mL,  mL, and  mL solutions were transferred into
each of four dierent  mL volumetric asks. e solution
grade methanol to get a concentration of  ppm,  ppm,
 ppm, and  ppm, respectively.
 mg of powdered KSM- root extract was transferred
was added to it. It was sonicated for – min with gentle
heat in ultrasonic bath. e solution nally was made up with
methanol to  mL. Prior to injection into the HPLC, this
clear solution was ltered using syringe ltration (. 𝜇m).
2.3. Clinical Study. is pilot study was double blind, pla-
cebo-controlled, randomized, and performed in accordance
with the ethical guidelines of “Declaration of Helsinki” and
approved by the Institutional Ethical Committee of Bharati
Vidyapeeth Deemed University, Navi Mumbai , India
(date of approval: October , ). e Ethical Committee
notications followed the Good Clinical Practice (GCP)
Guidelines issued by the Central Drugs Standard Control
Organization and Ethical Guidelines for Biomedical Research
on Human Subjects, issued by Indian Council of Medical
2.4. Study Subjects. Subject recruitment was initiated
through small clinics in dierent regions of a large city in
India. After obtaining written consent, we recorded demo-
graphic characteristics and physicians’ assessments from
clinical examinations and laboratory diagnostics. Medical
personnel performed diagnosis and evaluation for FSD
hypoactive sexual desire disorder (HSDD), female sexual
arousal disorder (FSAD), female orgasmic disorder (FOD),
values of systolic and diastolic blood pressure, pulse rate,
temperature, respiratory rate, FSFI parameters, and FSDS
were assessed. e following inclusion and exclusion criteria
were applied.
Inclusion Criteria. Inclusion criteria are as follows:
() Female subjects aged –, in a steady heterosexual
relationship for over a year, previously or presently
engaged in sexual function for several years.
() Women who have a male partner with a score of
not impotent”or“minimally impotent” on the Single-
Question, Self-Report of Erectile Dysfunction (Mas-
sachusetts Male Aging Study).
() Women who have a baseline total score of < on the
FSFI and a baseline total score of > on FSDS.
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() Women who have the diagnostic conditions for FSD
with one or more of the following disorders:
(a) hypoactive sexual desire disorder (HSDD),
(b) female sexual arousal disorder (FSAD),
(c) female orgasmic disorder (FOD),
course with an intent-to-attain orgasm at least twice/
() Women who provide a written informed consent and
can meet all the study requirements.
() Women who are willing to use condom as a contra-
ceptive measure.
() Women who are able to speak, read, and write English
Exclusion Criteria. Exclusion criteria are as follows:
() Women who presented with indication of unsolved
sexual distress or exploitation, with FSD caused by
untreated endocrine disease, or chronic dyspareunia
not associated with vaginal dryness during the previ-
ous  months.
() Females with chronic or extensive medical or psychi-
atric sickness, drug abuse, infertility, and menopause,
those who are pregnant or lactating or using hor-
monal contraceptive pills, and women with known
hypersensitivity to ashwagandha.
() Use of any medications, herbal treatments, or dietary
supplements intended to enhance sexual function, in
the previous  months or during the study.
married women, not working in jobs, and coming from
auent households with domestic help. Physicians’ notes
suggest that the women led lives with high stress from social
demands, child rearing, and husbands’ high expectations.
Qualitative interviews indicated that career women and full-
time homemakers were reluctant to participate in this study
for an inability to comply with the needs and schedule of the
study. All of these factors contributed to the study sample
being relatively homogeneous.
2.5. Study and Treatment Protocol. e y female subjects
who met the selection criterion were randomly assigned
either to the HCARE-treated group (Group A; 𝑛=25)
or to the placebo-treated group (Group B; 𝑛=25)in
a randomized fashion. Subjects in both the groups went
through a counselling program consisting of two seminar
presentations and an individualized consulting session on
addressing FSD. e HCARE treatment was considered as
an adjunctive therapy to the counselling sessions. e study
2.6. Study Drug. HCAREwasgiveninthedoseofonecapsule
of  mg twice per day orally aer food with a glass of
plain water, over a period of  weeks. e same protocol was
followed for the placebo.
2.7. Dose Determination. Based on the withanolide concen-
tration of %, we assessed the extract ratio of KSM- to be
 : . e traditional dosage of ashwagandha raw root powder
is  mg twice a day, as reported in the literature, across
a variety of applications. Reducing the traditional dosage
2.8. Concomitant Medication. Any concomitant medication
required by the patient was prescribed at the discretion of
the investigator and/or the attending clinician in accordance
with routine clinical practice at the study site. Only those
medicines unlikely to interfere with the study outcomes were
2.9. Ecacy Parameters Evaluated and Measurements. e
Female Sexual Function Index (FSFI), the Female Sexual
Distress Scale (FSDS), the Sexual Activity Record (SAR),
the Patient’s Global Assessment of Response to erapy
(PGART), and the Patients Global Assessment of Tolerability
to erapy (PGATT) were used to assess the eectiveness of
HCARE to oset FSD. e primary and secondary measures
were made at the start and at the th and th weeks of
were obtained and veried by a competent clinical physician.
During the visit of each subject in the th week and th
week, the interviewer reminded her of the responses she
gave on the previous measurement occasion, consistent with
psychometric methodology to reduce interassay variation.
2.10. Primary Ecacy Outcomes
2.10.1. e Female Sexual Function Index (FSFI). e FSFI is
a self-report -item survey instrument developed by Rosen
et al. [] and was used to assess FSD extent in each of
our subjects. e instrument has domain scores for desire,
arousal, lubrication, orgasm, satisfaction, and pain. e FSFI
Total Score is a weighted sum of these. e FSFI questionnaire
was used at the beginning of the study (to establish the
baseline values), at  weeks, and at termination of the study
period (at  weeks).
2.11. Secondary Ecacy Outcomes
2.11.1. Female Sexual Distress Scale (FSDS). e FSDS is a self-
report -item survey instrument [] which measures sexu-
ally related personal distress in women. e items correspond
to various dimensions of sexual distress and are each to be
rated according to the assessed occurrence frequency in the
previous  days.
2.11.2. Sexual Activity Record (SAR). Assessment of the tem-
poral improvement in sexual activity relative to the baseline
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values following administration of the specic therapy was
based on the Sexual Activity Record (SAR), which measured
the encounter frequency of “sexual events” and “successful
and satisfactory sexual events.”
2.12. Patients Global Assessment of Response to erapy
(PGART). PGARTwasevaluatedbythestudysubjects,at
the end of therapy, on a -point scale representing the
degree of improvement in sexual activity and sexual sat-
isfaction in the following categories: “Excellent response,”
“Good response,” “Moderate response,” “Poor response,” and
“Worst response.”
2.13. Patients Global Assessment of Tolerability to erapy
(PGATT). Safety was assessed on the basis of adverse events.
e subjects were monitored for any adverse drug reactions
and illnesses during the study. Any adverse events, either
spontaneously reported by the patient or noticed by the
physician, were recorded during the trial and forwarded to
the primary investigator in a blinded fashion. PGATT was
assessed on a -point scale with the following scale response
categories: “Excellent,” “Good,” “Moderate,” “Poor,” and
2.14. Compliance. Subjects were provided “erapy Kits”
containing the medications. At each visit, the investiga-
tor/study team noted the number of tablets dispensed and the
number of tablets returned by the subject. Any deviations or
dose missed was recorded in the Case Record Form and Drug
Accountability Log for enquiry. A patient was considered
compliant if % of medication was consumed according
to the prescribed regimen.
2.15. Data Evaluation and Statistical Analysis
2.15.1. Analysis Dataset. e recommended practice for clini-
cal trials is that all analysis be done on both the intent-to-treat
(ITT) and the per-protocol (PP) datasets. e ITT dataset
included all subjects recruited in the study irrespective
of their study completion status, whereas the PP dataset
included all subjects who completed the study without any
protocol violation. In our case, all the subjects completed the
study and therefore the ITT dataset and the PP dataset are
2.15.2. Data Analysis. Data are reported in terms of mean and
standard deviation (SD). Categorical data and discrete data
are expressed as numbers with percentages (proportions).
Time duration-related changes in each domain score value
in the th and th weeks relative to the baseline value in
the ashwagandha group were compared to the corresponding
values in the placebo-treated group. Statistical signicance
was determined using ANOVA tests, both Gaussian and
nonparametric Kruskal-Wallis. Bonferroni correction was
applied to determine the 𝑝value thresholds. e treatment
variable was a factor in the ANOVA. All testing was done
using two-sided tests at alpha = ..
W3-10.372 W2-10.945
F : HPLC chromatogram of ashwagandha root extract.
Screening for
Patient enrollment
Complied for ecacy
(n = 25) (n = 25)
Evaluation at 8th week (n = 25)
Evaluation at 4th week (n = 25)
Baseline evaluation (n = 25)
Allocated to KSM66 (n = 25)
Evaluation at 8th week (n = 25)
Evaluation at 4th week (n = 25)
Baseline evaluation (n = 25)
Allocated to placebo (n = 25)
Randomized (n = 50)
and safety analysis and safety analysis
Complied for ecacy
F : Flow diagram of patient distribution and study design.
3. Results
3.1. HPLC Study. Figure  depicts the HPLC chromatogram
extract contains over % withanolides.
3.2. Clinical Study. e clinical study design and patient
distribution are depicted in Figure . None of the  enrolled
attrition was very low perhaps because the study’s adminis-
trators, at the time of recruitment, communicated clearly the
commitment demanded by the study, thereby discouraging
those likely to drop out from enrolling. e general demo-
graphic characteristics of the subjects are provided in Table ;
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T : General demographic characters of the study subjects.
Parameters Ashwagandha root extract treated group (𝑛=25) Placebo-treated group (𝑛=25)
Mean Standard deviation Mean Standard deviation
Age (years) . . . .
Systolic blood pressure (mm Hg) . . . .
Diastolic blood pressure (mm Hg) . . . .
Pulse rate (per min) . . . .
Temper a t u r e ( F) . . . .
Respiratory rate (per min) . . . .
13.63 17.69
Mean (bars are standard deviation)
Week 4 Week 8Baseline
Placebo (n = 25)
Ashwagandha (n = 25)
F : Mean Female Sexual Function Index (FSFI) Total Score in
ashwagandha root-treated group and placebo-treated group [∗∗𝑝<
0.001 ashwagandha root extract treated group versus placebo-
treated group].
Mean (bars are standard deviation)
Week 4 Week 8Baseline
Placebo (n = 25)
Ashwagandha (n = 25)
F : Mean score for “desire” domain of Female Sexual Func-
tion Index (FSFI) in ashwagandha root-treated group and placebo-
treated group.
there was no signicant across-group dierence. e study
subjects’ mean age was 28.12 ± 5.12 in the HCARE-treated
group (Group A; 𝑛=25)and29.44 ± 6.14 in the placebo-
treated group (Group B; 𝑛=25).
e time-specic and group-specic mean values and
standard deviations for the key outcome measures are
depicted graphically through the points’ coordinates and
error bars, respectively, in Figures –. e gures visually
2.68 2.74
Mean (bars are standard deviation)
Week 4 Week 8Baseline
Placebo (n = 25)
Ashwagandha (n = 25)
F : Mean score for “arousal” domain of Female Sexual Func-
tion Index (FSFI) in ashwagandha root-treated group and placebo-
treated group [∗∗𝑝 < 0.001 ashwagandha root extract treated group
versus placebo-treated group].
3.48 3.80
2.44 3.00
Mean (bars are standard deviation)
∗∗ ∗∗
Week 4 Week 8Baseline
Placebo (n = 25)
Ashwagandha (n = 25)
F : Mean score for “lubrication” domain of Female Sexual
Function Index (FSFI) in ashwagandha root-treated group and pla-
cebo-treated group [∗∗𝑝 < 0.001 ashwagandha root extract treated
group versus placebo-treated group].
allow across-time and across-group comparisons of each
measure but not an across-group comparison of the overtime
increments. Comments on the statistical signicance of the
3.3. e Female Sexual Function Index (FSFI). All the women
enrolled in the present study had total FSFI scores suggestive
of FSD. e FSFI domain scores were suggestive of sexual
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3.28 3.41
2.83 2.91
Mean (bars are standard deviation)
Week 4 Week 8Baseline
Placebo (n = 25)
Ashwagandha (n = 25)
F : Mean score for “orgasm” domain of Female Sexual Func-
tion Index (FSFI) in ashwagandha root-treated group and placebo-
treated group [𝑝 < 0.01;∗∗𝑝 < 0.001 ashwagandha root extract
treated group versus placebo-treated group].
2.35 2.60 2.70
Placebo (n = 25)
Ashwagandha (n = 25)
Mean (bars are standard deviation)
Week 4 Week 8
F : Mean score for “satisfaction” domain of Female Sexual
Function Index (FSFI) in ashwagandha root-treated group and pla-
cebo-treated group [∗∗𝑝 < 0.001 ashwagandha root extract treated
group versus placebo-treated group].
problems linked to desire, orgasm, lubrication, satisfaction,
arousal, and pain. e mean total FSFI score at week  of the
study period was found to be . ±. in Group A and
. ±.inGroupB.Atweekofthestudyperiod,the
mean total FSFI score was . ±. in Group A and .
±. in Group B (Figure ). e increase in the FSFI Total
Score was signicantly higher in the HCARE group than in
the placebo group at both the -week point and the -week
point (𝑝 < 0.001 for both comparisons), evidencing that the
HCARE led to substantial improvement in FSD in otherwise
healthy women.
3.4. Desire Domain of FSFI. Figure  shows the mean ±
SD score for the desire domain of FSFI. e values are
comparable, within statistical error, between Group A and
Group B at week  and week , and relative to their respective
baseline values. ere was no signicant dierence between
HCARE and placebo in the desire domain score increase
from baseline to week  (𝑝 = 0.295)andweek(𝑝 = 0.119).
Improvement (%)
Week 8
Week 4
Placebo (n = 25)
Ashwagandha (n = 25)
F : Per cent improvement in the Mean Female Sexual Func-
tion Index (FSFI) Score for “pain” domain in ashwagandha root-
3.5. Arousal and Lubrication Domains of FSFI. e mean
FSFI arousal domain scores’ increments, relative to baseline,
were signicantly higher in Group A than in Group B at week
(𝑝 = 0.005)andweek(𝑝 < 0.001). For the lubrication
domain score, the eects were also strong, with the HCARE
group having greater improvement, relative to the placebo, at
week  (𝑝 = 0.004)andatweek(𝑝 < 0.001). See Figures 
and .
3.6. Orgasm and Satisfaction Domains of FSFI. For the
orgasm domain score, the improvement was signicantly
higher in the HCARE group than placebo, with a signicance
level of 𝑝 = 0.012 at the -week point and 𝑝 = 0.001 at
the -week point (Figure ). ere was a similar eect for
theFSFIdomainscoreforsatisfaction(with𝑝 = 0.001 at
 weeks and 𝑝 < 0.001 at  weeks), not surprising because
sexual satisfaction is seen in prior research to be associated
with orgasm (Figure ).
3.7. Pain Domain of FSFI. e -week and -week increments
in the mean FSFI domain score for pain were higher under
HCARE than placebo (𝑝 = 0.011 and 𝑝 = 0.002,resp.).
However, the dierence is not statistically signicant aer
Bonferroni correction (Figure ).
3.8. Female Sexual Distress Scale (FSDS). e mean FSDS
treated group (Group A) than in the placebo group, both at
week  (𝑝 < 0.001)andatweek(𝑝 < 0.001). See Figure .
3.9. Sexual Activity Record (SAR). No signicant improve-
ment was observed for the ashwagandha-treated group or
the placebo group in terms of the total number of sexual
encounters aer  weeks and  weeks. However, signicant
BioMed Research International
T : Mean number of total sexual encounters in ashwagandha root extract treated and placebo-treated groups.
Duration of the study Ashwagandha root extract treated group (𝑛=25) Placebo-treated group (𝑛=25)Unpaired𝑡-test
Mean Standard deviation Mean Standard deviation 𝑝
Baseline . . . . .
Week  . . . . .
Week  . . . . .
Change from baseline Mean change % change Mean change % change
Week  . . . . .
Week  . . . . .
T : Mean number of successful sexual encounters in ashwagandha root extract treated and placebo-treated groups.
Duration of the study Ashwagandha root extract treated group (𝑛=25) Placebo-treated group (𝑛=25)Unpaired𝑡-test
Mean Standard deviation Mean Standard deviation 𝑝
Baseline . . . . .
Week  . . . . .
Week  . . . . <.
Change from baseline Mean change % change Mean change % change
Week  . . . . .
Week  . . . . <.
Placebo (n = 25)
Ashwagandha (n = 25)
Mean (bars are standard deviation)
Week 4 Week 8Baseline
F : Mean Female Sexual Distress Scale (FSDS) Score in
ashwagandha root extract treated group and placebo-treated group
[∗∗𝑝 < 0.001 ashwagandha root extract treated group versus
placebo-treated group].
improvement was observed in the number of successful
sexual encounters. e improvement was signicantly greater
 weeks (𝑝 < 0.001) and not aer  weeks (𝑝 = 0.056)(Tables
(PGART). At the end of therapy (week ), the study subjects
assessed PGART on a -point scale capturing the extent of
improvement in sexual activity and sexual satisfaction. Of
therapy as “Excellent,”  as “Good,” and  as a “Moderate.”
e compliance was excellent for all the patients in both the
3.11. Patients Global Assessment of Tolerability to erapy
(PGATT). No adverse eects of therapy were observed in the
HCARE group. All the subjects (𝑛=25)showedexcellent
tolerability to the therapy. Examination of these data reveals
that the HCARE eectively ameliorated some inadequacies
in libido and in the psychophysiological variations that
characterize FSD.
4. Discussion
Sexual expression is a normal and healthy part of human
behaviour. Positive sexual experiences are related to health
and well-being throughout life; hence, there is a need to
think about sexual health as not simply the absence of sexual
disorders, but as a key factor aecting the quality of life [].
FSD is characterized by problems in the psychophysiological
variations combined with the “sexual response cycle.” ese
variations are oen due to underlying neurovascular, hor-
monal, or psychogenic aetiologies [].
olytic, antidepressant, and antistress adaptogen. It has been
found eective in stress-induced sexual dysfunctions in
animal models. e withanolides, steroidal lactones, are said
to be the important phytochemicals of ashwagandha and
among the active constituents responsible for the therapeutic
ecacies of the plant [].
ere are four ndings from the data analysis that are
worth highlighting at the outset, the rst two relating to the
population characteristics and the second two relating to the
BioMed Research International
intertemporal variation in the key outcome measures. First,
reports [–]. We attribute these lower scores to restrained
attitudes towards sex and towards talking about sex in this
specic object pool, owing to its Asian Indian cultural norms.
Second, the standard deviations in some of the key outcome
measures are lower than in other studies. We attribute this
to our subject group being relatively homogeneous and with
very similar sociodemographic characteristics, as we pointed
out earlier in this paper in Study Subjects. ird, there is
signicant across-time reduction in FSD (as measured by
group but also in the placebo group. Recall that both
groups’ subjects went through a counselling program. is
indicates that the counselling program even in the absence
of HCARE supplementation helps in FSD. Fourth, HCARE
appears useful as an adjuvant to the counselling program
in improving many but not all aspects of FSD. We nd
that the improvement in the FSFI scores from baseline to
week  is statistically signicantly greater under HCARE with
counselling than under placebo with counselling, for the
for orgasm, satisfaction, lubrication, and arousal but not for
desire and pain and the number of total sexual encounters.
e explanation for why HCARE treatment was useful in
reducing FSD may lie in two pathways: () ashwagandhas role
in reducing stress, which in turn is associated with FSD, and
() ashwagandhas role in increasing testosterone which is a
factor in androgen deciency syndrome which in turn is also
associated with FSD.
A noteworthy observation in the present study is the
substantial placebo-eect evident in the functional measures
of various domains of FSFI, in the FSDS scores and in
the Event Log Records of successful sexual encounters.
is observation conrms previous ndings that indicate a
marked placebo eect on sexual function of women with
sexual diculties [, ]. Several studies have noted major
placebo eects. Also noteworthy is the fact that the eects
shown under HCARE treatment are strongly signicantly
higher than in the placebo group. We have been careful
and conservative in our statistical signicance testing, using
recommended tests based on ANOVA under Gaussian and
nonparametric assumptions, and applying Bonferroni cor-
rections, thereby reducing the chances of a type I error.
It is important to make some cautionary notes on our
study’s results so that the reader is conservative and guarded
about the conclusion that HCARE supplementation can oset
FSD. e 𝑝values we obtained are considerably lower (and
the statistical signicances correspondingly higher) than in
similar studies. We believe that this is because of three
reasons: First, the subject group in our study is more homoge-
neous than in previous studies, in aspects identied near the
end of Study Subjects earlier in this paper. Second, because
in weeks  and  each subject was reminded of and anchored
on her responses on the previous measurement occasion, the
interassay variation was low in the survey instruments. ird,
our sample size of  per group was higher than the minimal
sample size of  calculated (on the basis of an independent
pretest sample of size ) to achieve discrimination power.
ese three factors likely resulted in substantially lower stan-
dard errors, for the key outcome measures, than in previous
studies, which led to higher values of the test statistics under
the null hypothesis and therefore led to smaller 𝑝values and
higher statistical signicance of the eect sizes.
As another cautionary note, we should emphasize that
our results should not be interpreted as implying that ash-
wagandha is an aphrodisiac. In our study, HCARE supple-
mentation failed to improve sexual “desire,” as seen in the
nonsignicant improvement in the FSFI “desire” domain
score and in the number of total sexual encounters.
5. Limitations
A major limitation of the present study design is the relatively
homogeneous subject group coming from a specic cross
section of society. While a homogenous subject group is
good in that it aords greater statistical discrimination power
and lower 𝑝values for any specic eect size, there is the
concern that the ndings may not generalize to broader cross
sections of the population. Future research needs to address
this concern by considering subjects with a wider range of
demographics, occupations, and socioeconomics. is was a
a larger sample size. Another major limitation is that the study
duration is only  weeks with three measurement points four
points may give insight into the temporal trajectory of the
6. Conclusion
e results suggest that ashwagandha root extract could be
useful for the treatment of FSD. e lack of adverse eects
suggests that the extract is safe to consume.
Conflict of Interests
ere is no conict of interests.
e authors thank Ixoreal Biomed, Los Angeles, Califor-
nia, the manufacturer of KSM- high-concentration root
extract, for providing the extract used in the study treatment
and for defraying some of the costs. ey initially tried to
procure the KSM- extract, without involving the manu-
facturer, via third parties that use this extract but they found
that most such parties incorporate llers and additives. is
made it dicult to obtain just the standalone extract without
approaching the manufacturer directly.
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... Regarding the radio sensitizing and antitumor effects of ashwagandha, it has been documented that the plant is used in the treatment of various cancer types [8] as in urethane induced lung adenomas and Chinese hamster ovary cells carcinoma. The plant is also considered an aphrodisiac and it is reported that the plant root extract is used to treat sexual weakness, erectile dysfunction, and performance anxiety in men [9]. Additionally, some compounds in the plant have revealed antiviral activity with recognizable effects on the viral receptors which might be valid against coronavirus [10,11]. ...
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... In one study, oral supplementation with high-concentration Ashwagandha root extract (HCARE) was shown to improve sexual function in healthy women. Compared to placebo, a significant improvement in sexual arousal, lubrication, orgasm, and an increase in the number of successful sexual intercourses was observed [64]. Chauhan et al., confirmed that compared to placebo, Ashwagandha root extract supplementation was associated with a statistically significant increase in the total DISF-M (derogatis interview for sexual functioning-male) scores [65]. ...
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In recent years, there has been a significant surge in reports on the health-promoting benefits of winter cherry (Withania somnifera), also known as Ashwagandha. Its current research covers many aspects of human health, including neuroprotective, sedative and adaptogenic effects and effects on sleep. There are also reports of anti-inflammatory, antimicrobial, cardioprotective and anti-diabetic properties. Furthermore, there are reports of reproductive outcomes and tarcicidal hormone action. This growing body of research on Ashwagandha highlights its potential as a valuable natural remedy for many health concerns. This narrative review delves into the most recent findings and provides a comprehensive overview of the current understanding of ashwagandha’s potential uses and any known safety concerns and contraindications.
... It helps men and women feel less anxious and depressed, as well as increase their sexual potency. [138][139][140] ...
... The maximum recommended starting dose of TFWS is 32.25 mg/kg/day or 1,935 mg/day for an adult weighing 60 kg. This is approximately five-fold higher than the proposed dose limit of 400 mg/day for an adult weighing 60 kg.histopathological examinations.28 Some rats in the high-dose groups showed inflammatory cell infiltration in the prostate and kidney; however, these symptoms were also observed in the control group. ...
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This study aimed at assessing the safety of a mixed extract of Trigonella Foenum-graecum seeds and Withania Somnifera root (TFWS), which effectively relieves male menopausal symptoms. To this end, male and female Sprague-Dawley rats were divided into the following groups and repeatedly administered TFWS orally for 90 days: control, low-dose (500 mg/kg/day), intermediate-dose (1,000 mg/kg/day), and high-dose (2,000 mg/kg/day) groups. The animals were monitored for general symptoms; their body weights and electrolyte levels were measured; urinalysis, blood chemistry, biochemistry tests, and histopathological tests were performed to assess the toxicity of TFWS. The no-observed-adverse-effect level of TFWS was 2,000 mg/kg/day for all male and female rats. While in the TFWS-administered and control groups, most parameters were within the normal range; some rats in the high-dose group showed changes not induced by the test substance but which may be specific to an individual animal or may occur naturally. Thus, based on our findings, we consider that TFWS may be a safe, non-toxic substance for alleviating male menopausal symptoms.
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... 2016). It has proven to rejuvenate the nervous system, cure insomnia, stress, lower blood pressure and is highly effective in preventing the development of stress induced ulcers (Dongre et al. 2015). Moreover, the high valued roots are used to treat ailments either alone or in combination with other herbals (Bhat et al. 2015). ...
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Background Withania somnifera has been the foundation of numerous contemporary medicines today for treatment of various diseases. However, phytochemical variability profile is lacking in the root and leaf organs. Aim This study was aimed to elucidate the phytochemical profile in seedling, vegetative and reproductive stages of leaf and roots in W. somnifera using High performance thin layer chromatography (HPTLC) fingerprinting. Methods The HPTLC with dual wavelength UV (254/366 nm) was used for the analysis of phytochemical variation in leaf and root methanolic extracts of W. somnifera. Results HPTLC chromatograms in 366 nm, 254 nm, and normal day light, seedling, vegetative and reproductive stages leaf and root exhibited bands variability. At 450 nm leaf HPTLC fingerprints in seedling stage showed five peaks with Rf values in the range of 0.42 to 0.90, vegetative stage with nine peaks of Rf values in range of 0.10 to 0.89, and reproductive stage with six peaks of Rf values in range of 0.30 to 0.92. In root showed six peaks with Rf values in range of 0.00 to 0.82 in seedling stage, ten peaks with Rf values in range of 0.00 to 0.96 in vegetative stage, seven peaks with Rf values in range of 0.01 to 0.91 in reproductive stage. In roots, higher peak areas were found at the reproductive stage (3.33%) compared to vegetative stage (1.65%). Conclusion The comparative HPTLC fingerprints of leaves and roots in W. somnifera presented phytochemical variability in leaf and root that varied with developmental stages.
... Another Indian RCT found improvement in sexual function in 50 women treated with 300 mg of ASW over 8 weeks, when compared to 50 placebo administered controls [93]. Both ASW and placebo were adjuncts to counseling as usual for female sexual dysfunction in a parallel group design. ...
Introduction Ashwagandha (ASW) is the extract of the plant Withania somnifera. It is widely used in complementary, alternative and integrative medicine (CAIM) but is little discussed in mainstream modern medical literature. Areas covered We performed a review of potential pharmacotherapeutic properties of ASW. Studies were sourced from relevant online and offline databases. In animal models, ASW displays antioxidant activity. It has GABAergic and other neurotransmitter modulatory effects. It reduces apoptosis and promotes synaptic plasticity. It improves cognition and reverses induced cognitive deficits. It attenuates indices of stress. In human subjects, ASW enhances adaptogenesis in healthy adults. It modestly benefits generalized anxiety disorder and obsessive-compulsive disorder, and symptom severity in schizophrenia, substance use disorders, and attention deficit hyperactivity disorder. It improves sleep quality. Expert opinion ASW may confer modest benefit in certain neuropsychiatric conditions. Its benefits may arise from induction of neuroplasticity, antioxidant and anti-inflammatory effects, and modulation of GABA and glutamate as well as other neurotransmitters. The antioxidant and anti-inflammatory actions may also benefit neurodegenerative states. Reports of clinical benefit with ASW must be interpreted with caution, given the paucity of randomized clinical trials (RCTs). Greater methodological rigor is necessary before clinical recommendations on ASW can be confidently made.
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Background Poor sexual function is a widespread problem affecting about 40% of women and this may worsen their quality of life. Ashwagandha (Withania somnifera) an adaptogenic herb has been reported to improve sexual satisfaction, sleep, and quality of life in women. Objective The purpose of the study was to evaluate the efficacy and safety of standardized Ashwagandha root extract in improving sexual function in healthy females. Methods In this prospective, randomized, placebo-controlled study, 80 women between 18 and 50 years of age without any hormonal disturbances and having hypoactive sexual desire disorder (HSDD) with a Female Sexual Function Index (FSFI) score <26, or Female Sexual Distress Scale (FSDS) score >11 were randomized to receive either capsule containing standardized Ashwagandha root extract 300mg twice daily (n=40), or identical placebo (n=40) for eight weeks. Sexual function was assessed using FSFI, FSDS, and Satisfying Sexual Encounters (SSEs). Assessments were done at baseline, four weeks, and eight weeks. Quality of life (QoL) was assessed using the general health questionnaire (GHQ-28) scale, and safety was assessed using clinical signs and symptoms. Repeat measures analysis of variance (ANOVA) was used for the assessment of treatment effect at different time periods. Nominal data were analyzed for differences using Fischer's Chi-square test. Results There was statistically significant improvement (p<0.0001) in FSFI scores with Ashwagandha [14.20 (0.98) at baseline to 22.62 (2.06) at week 8] as compared to placebo [14.17 (0.71) at baseline to 19.25 (2.23) at eight weeks], and this improvement was observed in all sub-scales (desire, arousal, lubrication, orgasm, sexual satisfaction, and pain) of the FSFI scale. There was a greater improvement (p<0.0001) in FSDS scores with AG as compared to placebo. Although not statistically significant (p, 0.078), there was a greater reduction (improvement) in GHQ-28 scores at eight weeks with Ashwagandha as compared to placebo, and this trend was observed for all domains of GHQ-28 (global, physical, psychological, and social function). More women with Ashwagandha had improvement in SSEs at week 4 (p, 0.017) and week 8 (p, 0.002) as compared to placebo. Adverse events were comparable in the two groups. Two women reported nausea and one reported drowsiness with AG, whereas two reported nausea, one reported drowsiness and one reported nausea with drowsiness in the placebo group. Conclusions Oral administration of Ashwagandha 300mg twice daily administered for eight weeks improves the female sexual health in otherwise healthy women who do not have any hormonal disturbances. Ashwagandha is a known adaptogen, maintains general well-being and improves vitality.
Ayurvedic Medicine, or Ayurveda, is a traditional Indian health care system. Research into the medicinal plants utilised in Ayurveda is becoming a global endeavour, and large pharmaceutical companies are investing in novel drug discovery from Ayurvedic sources as a number of clinical studies have demonstrated efficacy of natural products from Ayurvedic plant extracts against common ailments such as arthritis and diabetes. Ayurvedic medicine and its components have been well described in the past, but this book represents a comprehensive source on the biochemistry and mechanisms of the pharmacological effects of natural products from Ayurvedic sources. This book is a valuable resource for researchers in natural products and alternative sources of bioactive compounds in drug discovery, as well as pharmaceutical experts and those in industry.
Introduction All aspects of sexual function are related to sexual satisfaction, and not paying attention to sexual problems leads to sexual dissatisfaction. According to studies, sexual satisfaction is a key factor in a couple's quality of life. The aim of this study was to evaluate the safety and efficacy of wormwood vaginal gel in improving sexual function and sexual satisfaction in women of reproductive age. Methods This study was a randomized, triple-blinds, parallel-groups clinical trial performed on 76 women of reproductive age (18-45 years) referred to the gynecological clinic of Ghaem Hospital in Mashhad who had sexual dysfunction and low sexual satisfaction. 76 women were assigned to the wormwood gel (n = 38) and placebo (n = 38) groups using random permuted blocks of sizes 4 or 6 and an allocation ratio of 1:1. Wormwood gel or placebo was used for 4 weeks and 3 times a week for 4 weeks from22 May to 23 October 2021. The main data collection tools were the Female Sexual Function Index (FSFI) and Larson Sexual Satisfaction Questionnaire (LSSQ) to access changes in sexual function and sexual satisfaction at baseline and after 4 weeks. Results The Mean and Standard Deviation of the age of the studied women was 36.8 ± 5.9 years in the intervention group and 37.1 ± 7.3 years in the placebo group. Before the intervention, the Mean and Standard Deviation of the total score of sexual function and sexual satisfaction in the studied women were 17.70 ± 3.66 and 72.20 ± 6.56 in the intervention group and in the placebo group were 18.23 ± 3.84 and 73.26 ± 5.86, respectively. At the end of the intervention, the Mean and Standard Deviation of the total score of female sexual function and sexual satisfaction in the intervention group were 32.11 ± 2.03 and 96.91 ± 7.93 and in the placebo group were 21.07 ± 3.22 and 75.91 ± 8.87, respectively. sexual function and satisfaction improved significantly in the wormwood gel compared to the control group(p<0.0001). Conclusions Based on the findings of this trial, it seems that the wormwood vaginal gel can be used as a topical supplement to improve sexual function and sexual satisfaction in women of reproductive age who have sexual dysfunction and low sexual satisfaction.
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Background: Women report many nonvasomotor symptoms across the menopausal transition, including sleep disturbances, depressed mood, and sexual problems. The co-occurrence of these three symptoms may represent a specific menopausal symptom triad. We sought to evaluate the interrelatedness of disturbed sleep, depressed mood, and sexual problems in the Study of Women's Health Across the Nation (SWAN) and determine the characteristics of women exhibiting this symptom triad. Methods: SWAN is a multisite, multiethnic observational cohort study of the menopausal transition in the United States. Sleep disturbance, sexual problems, and depressed mood were determined based on self-report. Women who reported all three symptoms simultaneously were compared to those who did not. Logistic regression models estimated the association of demographic, psychosocial, and clinical characteristics with the symptom triad. Results: Study participants (n=1716) were 49.8 years old on average and primarily in very good or excellent health. Sixteen and a half percent had depressed mood, 36.6% had a sleep problem, and 42.2% had any sexual problem. Five percent of women (n=90) experienced all three symptoms. Women with the symptom triad compared with those without had lower household incomes, less education, were surgically postmenopausal or late perimenopausal, rated their general health as fair or poor, and had more stressful life events and lower social support. Conclusions: The symptom triad of sleep disturbance, depressed mood, and sexual problems occurred in only 5% of women, and occurred most often among women with lower socioeconomic status, greater psychosocial distress, and who were surgically menopausal or in the late perimenopause.
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A large body of literature supports the co-occurrence of depression, anxiety, and sexual dysfunction. However, the manner in which affective symptoms map onto specific female sexual response indices is not well understood. Aims. To examine changes in depression and anxiety symptoms their correspondence to fluctuations in desire, subjective arousal, genital response, orgasmic function, and vaginal pain. Methods. The present study used a two-week daily diary approach to examine same-day and temporal relations between affective symptoms and sexual function. Main outcome measures. The unique relations between shared and disorder-specific symptoms of depression and anxiety (i.e., general distress, anhedonia, and anxious arousal) and female sexual response (i.e., desire, subjective arousal, vaginal lubrication, orgasmic function, and sexual pain) were examined, while controlling for baseline levels of sexual distress, depression, and anxiety, as well as age-effects and daily menstruation. Results. Analyses revealed that changes in depression and anxiety severity corresponded to same-day variations in sexual response. Specifically, anhedonia (depression-specific symptom) was related to poorer same-day sexual desire, whereas greater anxious arousal (anxiety-specific symptom) was independently related to simultaneous increases in subjective sexual arousal, vaginal lubrication, and sexual pain. Increases in general distress (i.e., shared symptoms) were associated with greater same-day difficulties achieving orgasm. Notably, only one temporal relation was found, which indicated that higher levels of anhedonia predicted a next-day decrease in sexual desire. Conclusions. It is proposed that the simultaneous changes in affective symptoms and sexual function may indicate that they are products of shared underlying mechanisms. That is, in response to stress, the processes manifesting as feelings of low positive affect and amotivation are the very same processes responsible for diminished capacity for sexual desire. In contrast, the physiological hyperarousal associated with anxiety also gives rise to sexual arousal difficulties and vaginal pain.
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Sexual health is not merely the absence of disease, but the ability to have informed, consensual, safe, respectful, and pleasurable sexual relationships. The majority of the population are sexually active, most with someone of the opposite sex. The frequency and range of sexual practices that people engage in declines with age, but for many, sexual activity continues well into later life. Different aspects of sexual health affect people at different times throughout their lives. As people in the UK tend to first have sex around the age of 16, but do not start living with a partner until much later, the avoidance of sexually transmitted infections and unplanned pregnancy is necessary for many for a number of years. As people get older, their sexual health needs change and they become more concerned with the impact of their general health on their ability to have sex. Some people experience non-volitional sex (sex against their will); although this occurs typically in late teenage it may affect women and men at any age and so requires consideration throughout life. As many people find it difficult to talk about sex and sexual health matters, health professionals should make sexual health enquiry a component of their holistic healthcare.
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Ashwagandha (Withania somnifera) has been described in traditional Indian Ayurvedic medicine as an aphrodisiac that can be used to treat male sexual dysfunction and infertility. This pilot study was conducted to evaluate the spermatogenic activity of Ashwagandha root extract in oligospermic patients. Forty-six male patients with oligospermia (sperm count < 20 million/mL semen) were enrolled and randomized either to treatment (n = 21) with a full-spectrum root extract of Ashwagandha (675 mg/d in three doses for 90 days) or to placebo (n = 25) in the same protocol. Semen parameters and serum hormone levels were estimated at the end of 90-day treatment. There was a 167% increase in sperm count (9.59 ± 4.37 × 10(6)/mL to 25.61 ± 8.6 × 10(6)/mL; P < 0.0001), 53% increase in semen volume (1.74 ± 0.58 mL to 2.76 ± 0.60 mL; P < 0.0001), and 57% increase in sperm motility (18.62 ± 6.11% to 29.19 ± 6.31%; P < 0.0001) on day 90 from baseline. The improvement in these parameters was minimal in the placebo-treated group. Furthermore, a significantly greater improvement and regulation were observed in serum hormone levels with the Ashwagandha treatment as compared to the placebo. The present study adds to the evidence on the therapeutic value of Ashwagandha (Withania somnifera), as attributed in Ayurveda for the treatment of oligospermia leading to infertility.
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Withania somnifera (WS) has historically been used in Asia for treating stress-related health conditions. In this study, we investigated the effects of standardized WS root and leaf extract (WSE) in chronically stressed humans in a modern clinical trial. Participants were randomly assigned to WSE (125 mg QD, 125 mg BID, or 250 mg BID) or placebo groups. Stress levels were assessed at Days 0, 30, and 60 using a modified Hamilton anxiety (mHAM-A) scale. Biochemical and clinical variables were measured at Days 0 and 60. Of 130 subjects enrolled, 98 completed the study. Between Days 0 and 60, the WSE 125 mg QD group decreased significantly more than placebo for mean mHAM-A score, serum cortisol, serum C-reactive protein, pulse rate and blood pressure, and increased significantly for mean serum DHEAS and hemoglobin. Other WSE treat- ment groups had greater dose-dependent responses in these parameters and had significantly greater responses com- pared to placebo in mean fasting blood glucose, serum lipid profiles and cardiac risk ratios. Participants and dropouts reported no adverse effects. Therefore, this study provides evidence that the consumption of WSE significantly reduces experiential and biochemical indicators of stress without adverse effects.
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Context: Stress is a state of mental or emotional strain or tension, which can lead to underperformance and adverse clinical conditions. Adaptogens are herbs that help in combating stress. Ayurvedic classical texts, animal studies and clinical studies describe Ashwagandha as a safe and effective adaptogen. Aims: The aim of the study was to evaluate the safety and efficacy of a high-concentration full-spectrum extract of Ashwagandha roots in reducing stress and anxiety and in improving the general well-being of adults who were under stress. Settings and design: Single center, prospective, double-blind, randomized, placebo-controlled trial. Materials and methods: A total of 64 subjects with a history of chronic stress were enrolled into the study after performing relevant clinical examinations and laboratory tests. These included a measurement of serum cortisol, and assessing their scores on standard stress-assessment questionnaires. They were randomized to either the placebo control group or the study drug treatment group, and were asked to take one capsule twice a day for a period of 60 days. In the study drug treatment group, each capsule contained 300 mg of high-concentration full-spectrum extract from the root of the Ashwagandha plant. During the treatment period (on Day 15, Day 30 and Day 45), a follow-up telephone call was made to all subjects to check for treatment compliance and to note any adverse reactions. Final safety and efficacy assessments were done on Day 60. Statistical analysis: t-test, Mann-Whitney test. Results: The treatment group that was given the high-concentration full-spectrum Ashwagandha root extract exhibited a significant reduction (P<0.0001) in scores on all the stress-assessment scales on Day 60, relative to the placebo group. The serum cortisol levels were substantially reduced (P=0.0006) in the Ashwagandha group, relative to the placebo group. The adverse effects were mild in nature and were comparable in both the groups. No serious adverse events were reported. Conclusion: The findings of this study suggest that a high-concentration full-spectrum Ashwagandha root extract safely and effectively improves an individual's resistance towards stress and thereby improves self-assessed quality of life.
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Withania somnifera, commonly known as Ashwagandha, is an important medicinal plant that has been used in Ayurvedic and indigenous medicine for over 3,000 years. In view of its varied therapeutic potential, it has also been the subject of considerable modern scientific attention. The major chemical constituents of the Withania genus, the withanolides, are a group of naturally occurring C 28 -steroidal lactone triterpenoids built on an intact or rearranged ergostane framework, in which C-22 and C-26 are appropriately oxidized to form a six-membered lactone ring. In recent years, numerous pharmacological investigations have been carried out into the components of W. somnifera extracts. We present here an overview of the chemical structures of triterpenoid components and their biological activity, focusing on two novel activities, tumor inhibition and antiangiogenic properties of withaferin A and the effects of withanolide A on Alzheimer's disease. The most recent attempts in biotechnological production of withanolides are also discussed.
Withania somnifera, herbal rejuvenative tonic widely used by Ayurvedic physicians in India, was tested for its adaptogenic properties. Pretreatment with this drug increased the swimming endurance in mice. It prevented gastric ulcers induced chemically or by stress in rats. Milk-induced leucocytosis was also prevented in mice. The drug prevented increase in adrenal weight and decrease in ascorbic acid and Cortisol content of adrenals during stress. It appears to induce a state of non-specifically increased resistance (SNIR) during stress. © 1982 Informa UK Ltd All rights reserved: reproduction in whole or part not permitted.
Androgen deficiency in women has been recognized as a distinct clinical syndrome that affects thousands of women particularly women in the postmenopausal period of their life. This syndrome has been described by several names including female androgen deficiency syndrome as well as hypoactive, sexual desire disorder. A recent large survey concerning sexual problems in women also adds personal distress as a potential contributor to the low sexual desire found in some women with sexual dysfunction. Recognition of an androgen deficiency syndrome however, has been controversial and limited to a clinical diagnosis due to the lack of accurate and sensitive methods for measuring androgens in women. Up until now, available methods for measuring the sex steroids have been dependent on antibody based assays that employ a range of different detection systems including the use of isotopes such as tritium and I-125 or chemical signalling molecules that produce chemiluminescence. These assays have become increasingly more sensitive for the measurement of testosterone but are still incapable of providing the proper low-end sensitivity for analyzing testosterone in female blood specimens. Assays for testosterone performed either manually or with highly automated immunoassay instruments have been used to measure testosterone in women but with varying degrees of success. Existing immunoassay-based methods are quite adequate for measuring testosterone levels in males but lack sufficient sensitivity to accurately and reproducibly measure testosterone in females and pre-pubertal children. Recent advances with the use of ultrasensitive methods such as mass spectrometry coupled to either gas or liquid chromatography have improved the technology for measuring testosterone and other low concentration sex steroids like estradiol to the degree that mass spectrometry based methods are now capable of measuring the testosterone levels found in normal women and in women with extremely low levels of testosterone as observed in a true androgen deficiency disorder. This application of mass spectrometry for measuring testosterone should allow clinicians to better define female androgen deficiency and facilitate further investigation in the diagnosis and optimal management of androgen deficiency in women.
Many menopausal women experience climacteric symptoms including impairment of sexual function. Recent reports have suggested that Korean red ginseng (KRG) has a relaxing effect on the clitoral cavernosal muscle and vaginal smooth muscle in rats. We assessed whether KRG extracts would improve sexual function in menopausal women. Thirty-two menopausal women participated in a placebo-controlled, double-blind, crossover clinical study with administration of either three capsules of ginseng (1 g per capsule) or placebo daily. After completing the KRG or placebo arm, the participants were crossed over to the other arm after a 2-week washout period. The efficacy and safety of the KRG extracts were measured by using questionnaires. Female Sexual Function Index (FSFI) and Global Assessment Questionnaire (GAQ). Twenty-eight women completed the study. They were, on average, 51.2 + or - 4.1 years old, and their mean menopausal state was for a duration of 37.4 + or - 2.9 months. Few carryover effects were noted in either study arm. The ginseng extract significantly improved scores on the FSFI from 3.10 + or - 0.87 to 3.50 + or - 0.72 in the sexual arousal domain (P = 0.006). The GAQ was more significantly affected by ginseng extracts than by placebo (P = 0.046). There were no severe adverse events in the KRG group, although two cases of vaginal bleeding occurred during KRG treatment. Oral administration of KRG extracts improved sexual arousal in menopausal women. Red ginseng extracts might be used as an alternative medicine in menopausal women to improve their sexual life.