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Original Article
Body Weight Management in Adults Under
Chronic Stress Through Treatment With
Ashwagandha Root Extract: A Double-Blind,
Randomized, Placebo-Controlled Trial
Dnyanraj Choudhary, MD
1
, Sauvik Bhattacharyya, MPharm, PhD
2
,
and Kedar Joshi, MD
3
Abstract
Chronic stress has been associated with a number of illnesses, including obesity. Ashwagandha is a well-known adaptogen and
known for reducing stress and anxiety in humans. The objective of this study was to evaluate the safety and efficacy of a stan-
dardized root extract of Ashwagandha through a double-blind, randomized, placebo-controlled trial. A total of 52 subjects under
chronic stress received either Ashwagandha (300 mg) or placebo twice daily. Primary efficacy measures were Perceived Stress
Scale and Food Cravings Questionnaire. Secondary efficacy measures were Oxford Happiness Questionnaire, Three-Factor
Eating Questionnaire, serum cortisol, body weight, and body mass index. Each subject was assessed at the start and at 4 and 8
weeks. The treatment with Ashwagandha resulted in significant improvements in primary and secondary measures. Also, the
extract was found to be safe and tolerable. The outcome of this study suggests that Ashwagandha root extract can be used for
body weight management in adults under chronic stress.
Keywords
stress, food craving, Withania somnifera, weight gain, serum cortisol
Received November 18, 2015. Received revised February 11, 2016. Accepted for publication March 5, 2016.
Chronic psychological stress is a major health concern world-
wide and has been associated with numerous serious illnesses,
including depression, cardiac disease, diabetes, hypertension,
and possibly even cancer.
1
Excess stress is also associated with
symptoms such as muscle tension, gastrointestinal distur-
bances, sleep disturbances, cognitive dysfunction, headaches,
and fatigue.
Psychological stress has also been linked to weight-gain and
obesity.
2,3
Stress causes systemic elevation of stress hormones
such as cortisol, and chronic elevation of these hormones leads
to increased visceral adiposity and other metabolic syndrome.
4
Chronic stress may also lead to changes in eating beha-
vior.
5,6
The exacerbation of negative mood in response to
external stress elements is highly correlated with increased
food intake,
2
and chronic stress is also associated with reduced
physical activity.
5
Both these behaviors may have a significant
impact on body weight.
2
Increased cortisol production has been
shown to potentiate hunger.
7-9
Thus, there may be a physiolo-
gical component to the tendency to overeat during times of
stress. In addition, stress tends to elicit cravings for sweet and
fried foods, soft drinks, and alcoholic beverages
2,10
; these crav-
ings are linked to increased caloric consumption and resultant
higher body mass index.
10,11
This may be due to the fact that
chronic stress increases activation of the hypothalamic-
pituitary-adrenal axis, which has been found to increase sweet
cravings in persons prone to binge-eating sweet and fried
foods, soft drinks, and alcoholic beverages.
2
In double-blind studies of various herbal extracts tradition-
ally associated with calming and adaptogenic properties, links
were found between anxiety, stress, and body weight, and
patients who were treated showed marked reduction in body
weight and serum cortisol levels compared with placebo.
12,13
The root of the Ashwagandha plant (also known as Withania
somnifera), has a long history of use as an adaptogen in the
ayurvedic system of complementary medicine, and is used to
counteract the negative effects of stress. Modern research has
1
Indian Red Cross Society, Red Cross House, Pune, Maharashtra, India
2
NSHM Knowledge Campus, Kolkata, West Bengal, India
3
Bharati Vidyapeeth Medical College & Hospital, Sangli, Maharashtra, India
Corresponding Author:
Sauvik Bhattacharyya, MPharm, PhD, Department of Pharmaceutical
Technology, NSHM Knowledge Campus, 124 B. L. Saha Road, Kolkata
700053, West Bengal, India.
Email: dr.sauvik.bhattacharyya@gmail.com
Journal of Evidence-Based
Complementary & Alternative Medicine
2017, Vol. 22(1) 96-106
ªThe Author(s) 2016
Reprints and permission:
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DOI: 10.1177/2156587216641830
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begun to identify a number of active components in Ashwa-
gandha that may have useful therapeutic applications.
14
The
plant contains a range of bioactive constituents, including with-
anolides, glycowithanolides, sitoindosides, withaferin A, and
other therapeutically active phytochemicals.
15
Other studies
have identified anticancer, antidepressant, anxiolytic, cardiopro-
tective, antioxidant, thyroid modulating, immunomodulating,
antibacterial, neuroprotective, antifungal, anti-inflammatory,
and hematopoietic activities.
16
Several preclinical studies have indicated that Ashwa-
gandha does indeed have adaptogenic and antistress activities.
Jain et al
17
observed that Ashwagandha extract reduced dam-
age to hippocampal neurons in the CA2 and CA3 region by
80%. In another study, rodents pretreated with Ashwagandha
extract showed significant attenuation of hypercortisolemia
and other physiological indictors of stress. Also, the Ashwa-
gandha component withanolide A was found to reverse the
memory deficits and induce regeneration of dendritic spines
and axons in mice.
18
In another study with rodents, the antis-
tress potential of the Ashwagandha components sitoindoside
VII and VIII was established.
19
Additional studies have determined that extracts of Ashwa-
gandha root have significant anxiolytic properties in humans,
as measured both by patient-reported instruments and by quan-
titative analysis of serum biomarkers.
3,20,21
For example,
because of its GABAergic activity on ionotropic GABA-A and
GABA-rreceptors, it has shown efficacy in the treatment of
insomnia.
14
Chandrasekhar et al
1
evaluated the efficacy of a
standardized extract versus placebo in a 60-day clinical trial.
Significant differences were found for all the outcome mea-
sures, including scores on the Perceived Stress Scale
(P< .0001), the General Health Questionnaire (P< .0001), and
levels of cortisol in the bloodstream (P¼.0006).
12,13
Based on previous works linking stress to anxiety and
weight gain, the aim of the present randomized, double-blind,
placebo-controlled clinical study was to assess the efficacy of a
root extract of Ashwagandha root in improving general well-
being and reducing physiological markers of stress that have
been associated with obesity in adults under chronic stress. We
hypothesized that treatment with this extract would yield
anxiolytic and antistress effects, thus improving patient-
reported measures of psychological and physical well-being,
and normalizing serum cortisol levels, thereby reducing hunger
and stress-eating behaviors and reducing weight gain.
Materials and Methods
Patient Enrollment
Study subjects were selected from several outpatient clinics in the city
of Pune, India, who were intended for the treatment of stress and
overweight. Subjects were invited to the study center at Chaitanya
Hospital & Nursing Home, Pune, India for the study. All the subjects
received interventions at the study center only. Inclusion criteria
included the following: symptoms of chronic, routine work stress; age
between 18 and 60 years; ability to provide written informed consent;
a Perceived Stress Scale (PSS)
22
score 20, and a body mass index
between 25 and 39.9 kg/m
2
. Exclusion criteria included the following:
a diagnosable eating disorder; participation in a weight-loss program
in the past 3 months; predisposition to weight gain due to genetic or
endocrine conditions; diagnosed neurologic disorder, unstable medi-
cal condition, or known allergy/side effects to Ashwagandha root
extract; pregnancy or lactation; taking medications known to affect
weight (eg, corticosteroids, antidepressants, antipsychotics, mood sta-
bilizers, and antiepileptic drugs); participation in other clinical trials
during the previous 3 months; history of alcohol abuse or smoking;
and clinically significant acute unstable hepatic, renal, cardiovascular,
or respiratory disease.
The study was conducted in accordance with the Declaration of
Helsinki (1989) and ‘‘Guidelines for Clinical Trials on Pharmaceutical
Products in India’’—GCP Guidelines issued by the Central Drugs
Standard Control Organization, Ministry of Health, and Government
of India. Institutional review board approval was obtained from the
study center at Chaitanya Hospital & Nursing Home, Pune, India.
Ethics committee notifications as per Good Clinical Practice Guide-
lines, issued by Central Drugs Standard Control Organization and
Ethical Guidelines for Biomedical Research on Human Subjects,
issued by Indian Council of Medical Research, were followed.
Data Collection
This 8-week prospective clinical trial was conducted using a random-
assignment, parallel-group, single-centre, double-blind, placebo-
controlled design to evaluate the efficacy of Ashwagandha root extract
compared with placebo in reducing markers of stress, and in control-
ling weight gain and improving general well-being in adults under
chronic stress.
The study comprised a screening visit followed by an 8-week
treatment period. At the screening visit, medical history was obtained
from each subject and symptoms of chronic stress were assessed. A
general physical examination was conducted and vital parameters,
baseline body weight, body mass index, and baseline serum cortisol
levels were recorded. Each subject was then assessed using the PSS.
22
A qualified psychiatrist performed a clinical psychiatric examination
on each subject to check for primary psychiatric disorders that would
warrant exclusion from the study.
Randomization and Blinding
Following screening, eligible subjects were randomized through a
computer-based predetermined randomization (Rando version 1.0)
in a 1:1 ratio to receive either Ashwagandha root extract or placebo.
The randomization list had blocks of the same length and was non-
stratified. The study was a double blind one, that is, doctors and
subjects were unaware about the study groups. Both the drug and
placebo capsules were prepared as hard gelatin capsules having iden-
tical size, shape, color, texture, and weight. Also, the investigational
products were packaged in such a way that the extract and placebo
medication packs were identical in appearance. The packs were coded
to conceal their contents, and the label contained the subject serial
number (ID of the study). After the subject was enrolled, he or she was
provided with the medication pack having the corresponding serial
number. During data collection, neither the researchers nor the phy-
sicians had access to the randomization codes and were blinded to the
allocations. The unbinding was allowed only after completion of
entire data collection process or in case of serious adverse events. The
data analysts and the persons in charge of reporting the study results
Choudhary et al 97
were unaware of the identity of the study groups. The data were double
entered and blinded to the statisticians.
The study group received 300 mg of a standardized (containing
5%withanolides) Ashwagandha root extract (KSM-66 Ashwa-
gandha, Ixoreal Biomed, Los Angeles, CA) in capsule form, twice
daily with water for 8 weeks. The control group received identical
placebo capsules containing inert filler for the same period. Placebo
capsules were kept with a cloth-covered envelope that contained
Ashwagandha root extract for few days, so that the smell of Ashwa-
gandha is permeated to the placebo capsules and the smell of those
capsules became similar to Ashwagandha capsules. At the beginning
of the study and at the end of 4 and 8 weeks, subjects were assessed
using the outcome measures described below. In addition, body
weight, body mass index, serum cortisol levels, and vital parameters
were also recorded. Data on safety and adverse effects of the inves-
tigational drug were collected at the end of 8 weeks. Patients Global
Assessment of Tolerability to Therapy (PGATT) was assessed on a
5-point Likert-type scale at the end of therapy.
Clinical safety was assessed based on the adverse events reported
by the subjects during the follow-up or during clinical evaluation of
subjects. Adverse events were recorded, along with their severity,
duration and relationship to study drug. Assessment of the tolerabil-
ity of the Ashwagandha root extract was done through PGATT on a
5- p o i n t s c a l e o f ‘‘ w o r s t , ’’ ‘‘ p o or,’’ ‘‘moderate , ’’ ‘‘ g o o d , ’’ a n d ‘‘ e x c e l -
lent’’ tolerability at the end of therapy.
Outcome Measures
The primary outcome measures were the PSS
22
and the Food Cravings
Questionnaire–Trait (FCQ-T).
23
Secondary outcome measures
included the Oxford Happiness Questionnaire (OHQ),
24,25
the
Three-Factor Eating Questionnaire (TFEQ),
26
serum cortisol levels,
initial and final body weight, and body mass index.
The PSS instrument is used to measure psychological stress. This
14-item scale determines general stress experienced in the previous
month, with higher scores representing higher stress and possible
values ranging from 0 to 56. PSS evaluates physical and mental
depressive symptoms, requirement of health services, social anxiety,
and correlates with life-event scores.
22
Perceived stress was used as a
continuous variable in the present analysis to determine any effect of
treatment.
The FCQ-T is a 39-item, self-reported questionnaire that is used
to measure stable dimensions of food cravings, with answers based
on a 6-point Likert-type scale ranging from 1(never/not applicable)
to 6 (always). FCQ-T records 9 domains of food cravings: (1) plan-
ning to eat food, (2) positive reinforcement from eating, (3) relief
from negative mood by eating, (4) lack of control on overeating of
food, (5) thoughts about food, (6) physiological state, (7) emotions
that are involved during food cravings or eating, (8) environmental
cues that may trigger food cravings, and (9) guilt experienced due to
food craving.
23
The OHQ
24,25
consists of 29 questions that are answered on a 6-
point Likert-type scale (1 ¼strongly disagree, 6 ¼strongly agree).
The OHQ is an effective tool to measure happiness, well-being, and
optimism. In general, happiness and stress are believed to be inversely
proportional.
27
Therefore, reduction of the effects of stress may be
expected to improve general well-being in study subjects.
As noted above, serum cortisol levels are an indicator of stress
4
and
have been shown to affect appetite.
7-9
Therefore, cortisol represents an
effective parameter for measuring the antistress effect of
Ashwagandha in subjects under chronic stress and its impact on
weight gain.
7-9
The TFEQ used in this study was the Revised-TFEQ as explained
and revised by Cappelleri et al
28
and Karlsson et al
26
from the orig-
inal version of TFEQ by Stunkard and Messick.
29
This questionnaire
is used to determine eating behavior. It is a 4-point Likert-type
response format with a 3-factor structure containing 18 items. The
3-factor scales are ‘‘cognitive restraint,’’ ‘‘uncontrolled eating,’’ and
‘‘emotional eating.’’
Statistical Analyses
Baseline scores were compared with posttreatment scores using a
Friedman test followed by post hoc individual comparisons using a
Wilcoxon test. The 2 groups were compared for changes from baseline
in the scores using a Wilcoxon test.
All data were expressed as means with standard deviation. Cate-
gorical data and discrete data were expressed as numbers with percen-
tages. Changes in the scores from baseline were calculated and
expressed as mean change and percent change from baseline. Differ-
ences at the level of P< .05 were regarded as statistically significant.
Results
A total of 52 adults (38 men and 14 women) between the ages
of 18 and 60 years were enrolled in the present study, and
randomized to receive either treatment or placebo (Figure 1).
Of the 52 enrolled subjects, 2 (1 each in the placebo and
treatment group) were not compliant with the study protocol.
The data for the remaining 50 subjects were used for efficacy
analysis as per-protocol (PP) datasets. For safety analysis,
intent-to-treat (ITT) datasets were used. The ITT dataset
included all 52 subjects recruited for the study irrespective of
their study completion status.
The efficacy of the Ashwagandha root extract with regard
to weight management was evaluated using FCQ scores,
body weight, body mass index, and TFEQ scores, while the
efficacy in stress management was evaluated through PSS
and OHQ scores.
Baseline Occupational and Illness Characteristics
Occupational and baseline characteristics were comparable
across treatment groups in the trial (Table 1). The majority
of subjects (72%in Ashwagandha group and 68%in placebo
group) were found to be employed. The remaining subjects
were either students or housewives. All subjects in the trial
had chronic stress symptoms. The majority were troubled
with difficulties in concentration (60%in Ashwagandha
group and 44%in placebo group) and insomnia (60%in
Ashwagandha group and 44%in placebo group). About
44%of the subjects in Ashwagandha group and 52%in pla-
cebo group had problems with anxiety and restlessness. Other
major symptoms included physical exhaustion, mental fati-
gue, and headaches.
98 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
Outcome Measures
The primary and secondary outcomes of the trial are shown in
Table 2. The primary outcome of the study was obtained from
the PSS score. The treatment (Ashwagandha) and placebo
groups were similar with respect to baseline PSS scores (P¼
.759). At both subsequent time points, however, the mean PSS
score of the treatment group decreased significantly (Table 2).
This was a superior response compared with the placebo group
(P¼.05 at 4 weeks and P¼.0015 at 8 weeks). A reduction in
PSS scores was observed at the end of fourth and eighth weeks
for both the treatment and placebo groups. However, the treat-
ment group experienced a significantly greater degree of reduc-
tion than the placebo group at the end of the fourth week
(22.1%,P¼.0025) and the eighth week (32.7%reduction at
8 weeks, P< .0001).
The scores of FCQ components are also shown in Table 2.
The FCQ component ‘‘Planning’’ scores for the treatment
group were compared with the placebo group at baseline and
at the end of the fourth and eighth weeks. No significant dif-
ferences between the 2 groups were observed at baseline
(P¼.366) or fourth week (P¼.113) score. However, at the
Figure 1. CONSORT (Consolidated Standards of Reporting Trials) flow diagram. Patient distribution and study design.
Choudhary et al 99
end of the eighth week, the mean FCQ ‘‘Planning’’ score of the
treatment group was significantly lower than that of the pla-
cebo group (P¼.0406). A reduction of the mean FCQ ‘‘Plan-
ning’’ score from baseline to 4 and 8 weeks was observed for
both the treatment and placebo groups. However, the reduc-
tions of FCQ ‘‘Planning’’ scores for the treatment group at the
end of fourth week (P¼.0269) and eighth week (P¼.0087)
were statistically significant compared with the placebo group.
The mean FCQ ‘‘Positive Reinforcement’’ score of the treat-
ment group at the eighth week was found to be significantly
lower than that of the placebo group (P¼.0287). The mean
difference from the baseline FCQ ‘‘Positive Reinforcement’’
score at the end of the fourth week (P¼.0067) and eighth week
(P< .0001) for the treatment group were found to be significant
compared with the placebo group.
The mean FCQ ‘‘Negative Reinforcement’’ scores of the
treatment group at the fourth and eighth weeks did not show
any significant difference compared with the placebo group.
However, the mean reduction from the baseline FCQ ‘‘Nega-
tive Reinforcement’’ score for the treatment group showed a
significant difference from the placebo group at the fourth
week (P¼.008) and the eight week (P¼.0083). The mean
FCQ scores of the treatment group showed a significant reduc-
tion from baseline compared with the placebo group for the
following components: ‘‘Lack of Control’’ (fourth week, P¼
.0443; eighth week, P¼.0097), ‘‘Emotion’’ (fourth week, P¼
.0352; eighth week, P¼.0068), and ‘‘Environment’’ (eighth
week, P¼.039), during the study. However, the mean FCQ
component scores of the treatment group for the ‘‘Thoughts
about Food,’’ ‘‘Physiological,’’ and ‘‘Guilt’’ components did
not show any significant differences compared with the pla-
cebo group.
With regard to the secondary outcomes of this study, mean
OHQ scores were found to improve in both the placebo and
treatmentgroups over the 8-week period of study. However, at
the end of the eighth week, the mean OHQ score of the treat-
ment group improved significantly compared with the placebo
group (P¼.0087). At the end of the fourth week (P¼.0342)
and the eighth week (P< .0001), the mean increase of the OHQ
score from baseline for treatment group was significantly better
than for the placebo group, with an overall improvement of
19.18%.
Table 2 summarizes the changes in serum cortisol levels,
measured in mg/dL. Both the treatment and placebo groups
had similar serum cortisol levels at baseline (P¼.6835).
However, by the end of the study (eighth week), mean serum
cortisol levels of the treatmentgroup were significantly lower
compared with the placebo group (P¼.0132). After 4 and 8
weeks of treatment, a reduction from baseline of 16.05%and
22.2%, respectively, was observed in the treatment group.
The difference between the mean reductions of serum corti-
sol levels in the 2 groups after the fourth week (P¼.0328)
andeighthweek(P¼.0019) of treatment were statistically
significant.
Mean changes in body weight are shown in Table 2. The
body weight for both the treatment and placebo groups was
found to be reduced during the 8-week period of the study.
After 4 weeks of treatment, a mean reduction of 2.14%and
1.09%, from baseline was observed in the treatment and pla-
cebo groups, respectively, but the difference in reduction in the
2 groups was not statistically significant after 4 weeks
(P¼.0503). However, at the end of 8 weeks, the reduction
of body weight for the treatmentand placebo groups was 3.03%
and 1.46%, respectively. The data collected after 8 weeks of
treatment suggests a significant difference in mean reduction of
body weight for both groups (P¼.0148).
The mean body mass index for both groups was reduced
during the study (Table 2). After 4 and 8 weeks of treat-
ment, a mean reduction from baseline of 2.08%(P¼.0429)
and 2.93%(P¼.0096), respectively, was observed in the
treatment group, which was statistically significant com-
pared with the placebo group (fourth week, 1.03%;eighth
week, 1.4%).
Mean scores for the TFEQ components are shown in Table
2. During the study, the TFEQ-‘‘Cognitive Restraint’’ scores of
the treatment group did not show significant differences when
compared with the placebo group. However, the mean TFEQ
‘‘Uncontrolled Eating’’ and ‘‘Emotional Eating’’ scores
showed marked reduction from baseline scores for the treat-
ment group, which were statistically significant compared with
the placebo group at the end of the fourth week (‘‘Emotional
Eating,’’ P¼.0207) and the eighth week (‘‘Uncontrolled
Eating,’’ P¼.0247; ‘‘Emotional Eating,’’ P¼.0135) of the study.
Vital parameters such as systolic blood pressure, diastolic
blood pressure, pulse rate, respiratory rate and body tempera-
ture are summarized in Table 2. Mean systolic blood pressure,
diastolic blood pressure, and pulse rate were observed to
change to a similar extent in both groups. Respiratory rate and
body temperatures of the subjects of both groups were found to
be unaltered during the 8 weeks of the trial. Therefore, it can be
concluded that the treatment with Ashwagandha root extract
did not produce any significant changes in vital parameters
when compared with placebo.
Table 1. Baseline Occupational and Illness Characteristics (Intent-to-
Treat Population).
a
Ashwagandha
(n ¼25)
Placebo
(n ¼25)
Employment status
Housewife 3 (12) 4 (16)
Employed 18 (72) 17 (68)
Student 4 (16) 4 (16)
Stress symptoms
Difficulty in concentration 15 (60) 11 (44)
Physical exhaustion 7 (28) 1 (4)
Anxiety, restlessness 11 (44) 13 (52)
Insomnia 15 (60) 11 (44)
Headache 5 (20) 9 (36)
Fatigue 4 (16) 5 (20)
Loss of appetite 1 (4) 0 (0)
Mental confusion 0 (0) 1 (4)
a
Data are presented as number (percentage).
100 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
Table 2. Efficacy Analysis: Primary and Secondary Outcomes (Per-Protocol Population).
a
Ashwagandha (n ¼25) Placebo (n ¼25) PValue
Primary outcomes
Mean Perceived Stress Scale score
Baseline 20.31 (4.04) 19.96 (3.99) .759
Week 4 15.73 (4.38) 18.50 (5.33) .0519
Week 8 13.65 (3.14) 17.83 (5.16) .0015
Mean change from baseline:
At 4 weeks 4.48 (4.16) 1.46 (2.57) .0025
At 8 weeks 6.65 (4.80) 2.12 (2.68) <.0001
Mean Food Cravings Questionnaire scores—Component 1: Planning
Baseline 11.54 (4.55) 12.62 (3.87) .366
Week 4 10.12 (4.14) 11.92 (3.74) .1127
Week 8 9.35 (4.18) 11.67 (4.01) .0406
Mean change from baseline
At 4 weeks 1.42 (1.17) 0.71 (1.04) .0269
At 8 weeks 2.19 (1.70) 0.96 (1.49) .0087
Mean Food Cravings Questionnaire scores—Component 2: Positive Reinforcement
Baseline 19.12 (6.45) 20.54 (5.74) .4121
Week 4 16.65 (5.82) 19.92 (6.07) .0589
Week 8 15.92 (6.16) 19.62 (5.44) .0287
Mean change from baseline:
At 4 weeks 2.46 (1.88) 0.62 (2.58) .0067
At 8 weeks 3.19 (1.96) 0.92 (2.10) <.0001
Mean Food Cravings Questionnaire scores—Component 3: Negative Reinforcement
Baseline 10.73 (3.67) 10.46 (4.05) .805
Week 4 9.46 (4.23) 10.42 (4.11) .4218
Week 8 8.85 (4.08) 10.08 (4.17) .2947
Mean change from baseline
At 4 weeks 1.27 (1.78) 0.04 (1.33) .008
At 8 weeks 1.88 (2.32) 0.38 (1.47) .0083
Mean Food Cravings Questionnaire scores—Component 4: Lack of Control
Baseline 15.96 (4.32) 14.50 (4.49) .2476
Week 4 14.04 (3.49) 14.08 (4.20) .9676
Week 8 13.00 (3.64) 13.83 (4.31) .466
Mean change from baseline
At 4 weeks 1.92 (2.83) 0.42 (2.32) .0443
At 8 weeks 2.96 (3.49) 0.67 (2.46) .0097
Mean Food Cravings Questionnaire scores—Component 5: Thoughts About Food
Baseline 19.88 (6.87) 21.62 (5.48) .3253
Week 4 18.31 (6.69) 21.21 (6.06) .1142
Week 8 17.58 (7.27) 20.88 (5.97) .0851
Mean change from baseline
At 4 weeks 1.58 (2.94) 0.42 (2.95) .1704
At 8 weeks 2.31 (3.43) 0.75 (2.63) .0764
Mean Food Cravings Questionnaire scores—Component 6: Physiological
Baseline 11.73 (5.41) 12.33 (5.07) .6861
Week 4 10.96 (5.57) 12.08 (5.08) .46
Week 8 10.77 (5.64) 12.08 (4.94) .3843
Mean change from baseline
At 4 weeks 0.77 (1.82) 0.25 (1.94) .3347
At 8 weeks 0.96 (1.89) 0.25 (1.67) .1642
Mean Food Cravings Questionnaire scores—Component 7: Emotion
Baseline 14.46 (5.49) 13.21 (6.39) .4625
Week 4 12.85 (4.89) 12.83 (6.49) .9938
Week 8 12.15 (4.65) 12.67 (5.87) .7352
Mean change from baseline
At 4 weeks 1.62 (2.26) 0.38 (1.76) .0352
At 8 weeks 2.31 (2.65) 0.54 (1.67) .0068
(continued)
Choudhary et al 101
Table 2. (continued)
Ashwagandha (n ¼25) Placebo (n ¼25) PValue
Mean Food Cravings Questionnaire scores—Component 8: Environment
Baseline 15.46 (4.69) 15.67 (4.86) .8802
Week 4 13.62 (5.35) 14.79 (5.32) .4401
Week 8 12.77 (5.16) 14.29 (5.36) .3124
Mean change from baseline
At 4 weeks 1.85 (2.44) 0.88 (2.35) .1583
At 8 weeks 2.69 (2.33) 1.38 (2.06) .039
Mean Food Cravings Questionnaire Score—Component 9: Guilt
Baseline 8.69 (3.28) 8.04 (3.64) .5115
Week 4 8.12 (3.96) 7.79 (4.05) .7768
Week 8 7.81 (3.67) 7.58 (3.97) .8368
Mean change from baseline
At 4 weeks 0.58 (1.65) 0.25 (1.36) .4475
At 8 weeks 0.88 (1.42) 0.46 (1.44) .299
Secondary outcomes
Mean Oxford Happiness Questionnaire score
Baseline 28.88 (5.26) 29.17 (5.83) .8586
Week 4 32.58 (4.62) 30.21 (7.59) .1949
Week 8 34.42 (4.69) 30.21 (6.01) .0087
Mean change from baseline
At 4 weeks 3.69 (4.43) 1.04 (4.16) .0342
At 8 weeks 5.54 (4.64) 1.04 (3.06) <.0001
Mean serum cortisol level (mg/dL)
Baseline 17.25 (4.41) 16.76 (3.95) .6835
Week 4 14.47 (2.94) 15.63 (3.07) .1798
Week 8 13.41 (2.17) 15.44 (3.20) .0132
Mean change from baseline
At 4 weeks 2.77 (3.09) 1.13 (2.14) .0328
At 8 weeks 3.83 (3.18) 1.32 (2.10) .0019
Mean body weight (kg)
Baseline 76.35 (8.71) 77.16 (8.46) .7383
Week 4 74.70 (7.81) 76.32 (7.99) .4733
Week 8 74.03 (7.29) 76.03 (7.72) .3523
Mean change from baseline
At 4 weeks 1.64 (1.57) 0.84 (1.24) .0503
At 8 weeks 2.32 (1.99) 1.13 (1.24) .0148
Mean body mass index (kg/m
2
)
Baseline 26.88 (1.62) 27.17 (1.32) .4793
Week 4 26.32 (1.51) 26.89 (1.30) .1579
Week 8 26.09 (1.34) 26.80 (1.35) .0696
Mean change from baseline
At 4 weeks 0.56 (0.51) 0.28 (0.42) .0429
At 8 weeks 0.79 (0.65) 0.38 (0.40) .0096
Mean Three-Factor Eating Questionnaire score—Component 1: Cognitive Restraint
Baseline 13.19 (4.78) 13.50 (6.15) .8452
Week 4 12.08 (4.96) 13.00 (6.19) .5656
Week 8 11.54 (4.82) 12.38 (5.33) .5644
Mean change from baseline
At 4 weeks 1.12 (2.37) 0.50 (1.98) .3228
At 8 weeks 1.65 (2.17) 1.12 (2.33) .4114
Mean Three-Factor Eating Questionnaire score—Component 2: Uncontrolled Eating
Baseline 23.69 (5.36) 22.75 (5.42) .5399
Week 4 19.92 (6.10) 20.83 (5.66) .5867
Week 8 18.85 (4.67) 20.17 (6.13) .399
Mean change from baseline
At 4 weeks 3.77 (3.28) 1.92 (3.35) .0542
At 8 weeks 4.85 (3.78) 2.58 (3.11) .0247
(continued)
102 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
Safety Analysis
At the end of 8 weeks of treatment, subjects were evaluated
with the PGATT test, on a 5-point scale, which is done based
on the ITT population. The majority of the subjects in both the
treatment (96%) and placebo group (96%) reported ‘‘excel-
lent’’ tolerability.
Adverse Events
Data on adverse events were collected and analyzed for the ITT
population, considering all 52 subjects. Only 2 subjects (4%)
out of 52 reported effects such as giddiness, heaviness of head,
blurring of vision, and/or hyperacidity. The severity of these
adverse events was mild and temporary. The treatment was
tolerable to most of the subjects in both groups.
Discussion
This prospective, randomized, double-blind clinical study eval-
uated the safety and efficacy of a standardized Ashwagandha
root extract in 52 subjects suffering from chronic stress and
related disorders. The aim of the study was to analyze the
impact of the extract on food cravings and body weight man-
agement compared with a placebo. The results indicate that the
treatment with Ashwagandha root extract was more effective
than that with placebo.
Treatment with Ashwagandha root extract resulted in a
marked reduction of mean scores on the PSS compared with
baseline values at both 4 and 8 weeks. The treatment group
exhibited significantly greater improvement than the placebo
group. This result is in accordance with the findings of Chan-
drasekhar et al,
1
who observed a 44%reduction of PSS score
from baseline was observed at the end of a 60-day study with
64 subjects. The other measures of efficacy used in this study
also showed significantly greater improvement in the treatment
group than the placebo group. These included measures of
well-being and happiness, food cravings, reactive eating, serum
cortisol levels, and body weight.
Chronicstressisacommonproblem in modern life. Indi-
viduals experiencing prolonged stress are prone to overeating
and improper diet maintenance.
2
Food cravings can be linked
with higher consumption of palatable foods, thereby leading
to increased body mass index. These cravings are known to
mediate stress-related weight gain.
11
In the present study,
mean FCQ scores for ‘‘Planning,’’ ‘‘Positive Reinforcement,’’
‘‘Negative Reinforcement,’’ ‘‘Lack of Control,’’ ‘‘Emotion,’’
and ‘‘Environment’’ were reduced significantly (P<.05)after
8 weeks of treatment with Ashwagandha root extract, when
compared with placebo. However, mean FCQ component
Table 2. (continued)
Ashwagandha (n ¼25) Placebo (n ¼25) PValue
Mean Three-Factor Eating Questionnaire score—Component 3: Emotional Eating
Baseline 9.46 (2.28) 9.46 (2.38) .9961
Week 4 8.27 (2.49) 9.21 (2.19) .1623
Week 8 7.96 (2.65) 9.08 (2.08) .1011
Mean change from baseline
At 4 weeks 1.19 (1.55) 0.25 (1.22) .0207
At 8 weeks 1.50 (1.86) 0.38 (1.17) .0135
Vital parameters
Mean systolic blood pressure (mm Hg)
Baseline 120.88 (8.04) 122.80 (7.42) .385
Change at 4 weeks 0.96 (6.83) 2.08 (7.99) .597
Change at 8 weeks 2.24 (13.62) 4.56 (6.42) .445
Mean diastolic blood pressure (mm Hg)
Baseline 74.72 (4.96) 75.60 (4.83) .528
Change at 4 weeks 2.00 (6.63) 0.16 (5.51) .216
Change at 8 weeks 0.08 (5.90) 0.96 (5.45) .521
Mean pulse rate (per minute)
Baseline 76.16 (4.20) 76.64 (3.82) .674
Change at 4 weeks 0.80 (4.65) 0.08 (4.14) .484
Change at 8 weeks 1.76 (4.70) 2.08 (4.67) .810
Mean respiratory rate (breaths per minute)
Baseline 15.92 (0.64) 16.00 (0.29) .572
Change at 4 weeks 0.08 (0.64) 0.04 (0.35) .785
Change at 8 weeks 0.24 (0.66) 0.16 (0.37) .602
Mean body temperature (F)
Baseline 98.08 (0.09) 98.09 (0.07) .481
Change at 4 weeks 0.03 (0.11) 0.00 (0.08) .390
Change at 8 weeks 0.04 (0.11) 0.04 (0.10) 1.000
a
Data are presented as mean (standard deviation).
Choudhary et al 103
scores of the treatment group for ‘‘Thoughts about Food,’’
‘‘Physiological,’’ and ‘‘Guilt’’ did not show significant
changes during the study. These results support the conclu-
sion that because of the anxiolytic and antistress properties of
Ashwagandha, subjects rejected the use of food as a method
for coping with stress. Cravings for food due to stress can lead
to unconscious eating. Consequently, we can see that
‘‘Thoughts about Food,’’ ‘‘Physiological,’’ and ‘‘Guilt’’ para-
meters were not affected due to the treatment. Similar results
were obtained from the TFEQ study. Scores for ‘‘Uncon-
trolled Eating’’ and ‘‘Emotional Eating’’ were reduced signif-
icantly (P< .05) after 8 weeks of Ashwagandha treatment but
were not reduced for ‘‘Cognitive Restraint.’’ It has been
observed previously that higher scores on the ‘‘Uncontrolled
Eating’’ and ‘‘Emotional Eating’’ subscales are related to a
higher preference of energy-dense foods.
30
The reduction of body weight and body mass index
observed in the present study further supports hypothesis that
Ashwagandha root extract exerts antistress activity, resulting in
reduced food cravings and better eating behaviors (as reflected
in improved FCQ and TFEQ scores).
Stress-induced increase in serum cortisol level leads to
increased visceral fat deposition in humans. Prolonged stress
also increases circulating glucocorticoid concentrations, which
eventually promotes the ingestion of carbohydrates and fat and
decreased energy expenditure by suppressing corticotropin-
releasing hormone and stimulating neuropeptide hypothalamic
secretion.
4
Low leptin levels have also been associated with
increased symptoms of depression.
30
Leptin is a hormone that
regulates energy balance by suppressing food intake, and
thereby induces weight loss. Stress reduction restores normal
leptin levels and helps control obesity.
31
These results further
support the hypothesis that treatment with Ashwagandha can
be helpful in limiting stress-associated weight gain in humans.
The potential of Ashwagandha as a natural antistress and
antianxiety therapeutic has been strongly supported by previ-
ous researchers.
1,3,20,21
The results of the present study have
taken this analysis a step further and demonstrated that Ashwa-
gandha may provide a potential additional benefit of supporting
the maintenance of normal weight (or even weight loss) in
people living with chronic stress.
Ashwagandha is generally considered a harmless and easily
tolerated medication with few adverse effects or withdrawal
symptoms. Long-term administration of Ashwagandha root
extract has been found to be safe in various studies.
1,32-34
The
results of the present study are consistent with those of previous
studies, with Ashwagandha exhibiting a good safety profile and
negligible adverse events.
Limitations
The major limitation of the present study design is the rela-
tively small sample size. A study with a larger population
involving a wider cross-section of the subjects with regard to
age groups, occupation, and socioeconomic background would
provide more conclusive results. Study duration should also be
increased in future research to evaluate the long-term effects of
Ashwagandha root extract. Also, it would be useful to measure
additional parameters, such as serum leptin and ghrelin levels
involved in appetite regulation. However, this preliminary
study offers a useful guide for future studies with Ashwa-
gandha root extract or other herbal medicines.
Conclusion
The results of this study suggest that Ashwagandha root extract
reduces psychological and physiological markers of stress,
improves mental well-being, and reduces serum cortisol level
and food cravings and improves eating behaviors. A statisti-
cally significant reduction in body weight and body mass index
were observed in patients treated with Ashwagandha root
extract compared to placebo. Therefore, we conclude that Ash-
wagandha root extract can be useful for body-weight manage-
ment in patients experiencing chronic stress. However, further
studies are required to bolster the potential of Ashwagandha to
prevent weight gain caused by long-term chronic stress.
Acknowledgments
The authors thank Ixoreal BioMed of Los Angeles, California, USA,
for supplying the KSM-66 high-concentration root extract used in the
study treatment.
Author Contributions
DC, principal investigator, was involved int designing clinical trial
and protocol, data collection, and data analysis. SB contributed toward
data analysis, writing and drafting the manuscript, presentation, bib-
liography, and managed correspondence. KJ was responsible for data
collection, data treatment, and data analysis. All authors were
involved in the writing and drafting, and all read and approved the
final manuscript.
Declaration of Conflicting Interests
The authors declared no potential conflicts of interest with respect to
the research, authorship, and/or publication of this article.
Funding
The authors disclosed receipt of the following financial support for the
research, authorship, and/or publication of this article: The parent
organization of the principal investigator has provided the support for
the research and publication of this article.
Ethical Approval
The study was conducted in accordance with the Declaration of Hel-
sinki (1989) and ‘Guidelines for Clinical Trials on Pharmaceutical
Products in India—GCP Guidelines issued by the Central Drugs Stan-
dard Control Organization, Ministry of Health, and Government of
India. Institutional Review Board approval was obtained from the
study center at Chaitanya Hospital & Nursing Home, Pune, India.
Reference number: ECR/66/Inst/MH/2013. Ethics Committee notifi-
cations as per Good Clinical Practice Guidelines, issued by Central
Drugs Standard Control Organization and Ethical Guidelines for Bio-
medical Research on Human Subjects, issued by Indian Council of
Medical Research, were followed.
104 Journal of Evidence-Based Complementary & Alternative Medicine 22(1)
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