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

Abstract

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.

Full text

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; drdgl@hotmail.com
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
andinallformsofsexualdysfunction[–],particularly
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
http://dx.doi.org/10.1155/2015/284154

BioMed Research International
root extract (HCARE) may reduce FSD. ere are two routes
through which this hypothesis may hold. e rst route lies in
ashwagandha’s 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
inwomentendtodecreasewithage,andreducedtestosterone
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
waslleduptothemarkofeachoftheaskswithHPLC
grade methanol to get a concentration of  ppm,  ppm,
 ppm, and  ppm, respectively.
 mg of powdered KSM- root extract was transferred
toamLvolumetricaskandaboutmLofmethanol
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
Research.
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),
andcombinedgenitalandsubjectivearousal.ebaseline
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.

BioMed Research International 
() 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),
(d)combinedgenitalandsubjectivearousaldisor-
der.
()Womenwhoarewillingtoengageinsexualinter-
course with an intent-to-attain orgasm at least twice/
week.
() 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
uently.
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.
osewhowerenallyenrolledintothestudyweremostly
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
durationwasweeksforeachsubject.
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
commensurately,wearrivedatthedosageofmgtwiceper
day.
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
allowedtobeprescribed.
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
thestudy.eseprimaryandsecondaryoutcomeratings
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. Patient’s 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
“Worst.”
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
equivalent.
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 = ..
2.523
2.719
W5-5.154
5.995
W3-10.372 W2-10.945
W1-14.710
W6-16.525
0.000
0.010
0.020
0.030
0.040
0.050
0.060
0.070
0.080
(AU)
2.00
8.00
0.00
4.00
6.00
12.00
20.00
22.00
10.00
14.00
24.00
16.00
18.00
(min)
F : HPLC chromatogram of ashwagandha root extract.
Screening for
eligibility
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
ofHCAREusedinthisstudy.eresultsrevealedthatthe
extract contains over % withanolides.
3.2. Clinical Study. e clinical study design and patient
distribution are depicted in Figure . None of the  enrolled
womenwaswithdrawnfromthestudyforanyreason.e
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 ;

BioMed Research International 
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) . . . .
13.57
20.25
23.86
13.63 17.69
20.06
0.00
5.00
10.00
15.00
20.00
25.00
30.00
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].
1.80
2.98
4.01
1.75
2.74
3.70
0.00
1.00
2.00
3.00
4.00
5.00
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
2.18
3.01
3.54
2.14
2.68 2.74
∗∗
∗∗
0.00
1.00
2.00
3.00
4.00
5.00
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].
2.39
3.48 3.80
2.44 3.00
3.19
0.00
1.00
2.00
3.00
4.00
5.00
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
latteraremadeinthetextbelow.
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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1.87
3.28 3.41
1.92
2.83 2.91
0.00
1.00
2.00
3.00
4.00
5.00
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].
2.34
3.22
3.79
2.35 2.60 2.70
Placebo (n = 25)
Ashwagandha (n = 25)
0.00
1.00
2.00
3.00
4.00
5.00
Mean (bars are standard deviation)
Week 4 Week 8
Baseline
∗∗
∗∗
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).
43.32
77.54
26.65
58.84
0
10
20
30
40
50
60
70
80
90
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-
treatedgroupandplacebo-treatedgroup.
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
scoreincreasedstatisticallysignicantlymoreintheHCARE-
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  . . . . <.
16.28
10.16
6.36
16.24
13.24
11.96
Placebo (n = 25)
Ashwagandha (n = 25)
0.00
5.00
10.00
15.00
20.00
25.00
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
intheHCAREgroupthanintheplacebogroupbutonlyaer
 weeks (𝑝 < 0.001) and not aer  weeks (𝑝 = 0.056)(Tables
and).
3.10.Patient’sGlobalAssessmentofResponsetoerapy
(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
thesubjectsinGroupA,scoredtheresponsetothe
therapy as “Excellent,”  as “Good,” and  as a “Moderate.”
e compliance was excellent for all the patients in both the
groups.
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 [].
Ashwagandhaisshownintheliteraturetobeananxi-
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,
theFSFIscoreswesawweremarkedlylowerthaninother
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
theFSFIandtheFSDS)notonlyintheHCAREtreatment
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
numberofsuccessfulencountersandtheFSFIdomainscores
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: () ashwagandha’s role
in reducing stress, which in turn is associated with FSD, and
() ashwagandha’s 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
pilotstudywithonlysubjectsandshouldbereplicatedwith
a larger sample size. Another major limitation is that the study
duration is only  weeks with three measurement points four
weeksapart.Alongerdurationstudywithmoremeasurement
points may give insight into the temporal trajectory of the
eects.
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.
Acknowledgments
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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