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A Standardized Withania Somnifera Extract Signific
A Standardized Withania Somnifera Extract Signific
A Standardized Withania Somnifera Extract Signific
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5 authors, including:
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1. Research and Development Center, Natreon Inc., Salt Lake City, Kolkata, India
2. Central Research Institute (Ayurveda), Ministry of Health and Family Welfare,
Govt. of India, Bidhan Nagar, Kolkata, India
3. Director of Scientific Affairs, NutraGenesis LLC, Brattleboro, Vermont
Age, mean (SD), y 37.8 (12.4) 39.4 (12.6) 40.0 (9.9) 42.1 (9.6)
Weight, mean (SD), kg 58.9 (9.9) 60.5 (9.0) 59.1 (9.2) 59.1 (6.6)
Height, mean (SD), cm 161.8 (9.3) 161.5 (7.7) 162.7 (7.3) 159.4 (6.7)
(n = 19) (0.7) (0.7)† (0.7)†‡ (1.0) (0.8)† (0.6)† (1.2) (0.8)† (0.7)† (0.6) (0.8)† (0.7)†‡ (1.0) (0.8)† (0.6)† (0.8) (0.7)† (0.6)†‡
WSE 125 mg BID 2.9 1.3 0.6 1.6 0.8 0.4 1.9 1.3 0.9 1.7 0.8 0.5 1.7 0.8 0.5 3.6 2.0 0.9
† †‡ † † † † † † † †‡ †
(n = 30) (0.9) (1.0) (0.6) (1.1) (0.9) (0.6) (1.1) (0.6) (0.4) (1.1) (0.7) (0.6) (1.1) (0.7) (0.6) (0.6) (0.9) (0.8)†‡
WSE 250 mg BID 3.0 1.4 0.4 1.8 0.7 0.4 1.8 1.2 0.8 1.4 1.0 0.8 1.7 0.5 0.3 3.1 1.4 0.5
† †‡ † † † † † †‡ † †‡ †
(n = 34) (1.0) (0.8) (0.5) (1.0) (0.7) (0.5) (1.3) (0.4) (1.3) (0.7) (0.4) (0.4) (1.0) (0.6) (0.5) (0.7) (0.6) (0.7)†‡
Placebo 2.9 2.9 2.7 1.9 1.7 1.5 1.5 1.5 1.5 1.2 1.5 1.5 2.1 1.9 1.8 3.1 3.0 3.2
(n = 15) (1.0) (0.9) (0.8) (1.0) (1.2) (0.9) (0.9) (1.1) (0.7) (0.6) (0.5) (0.5) (0.8) (0.8) (0.8) (1.0) (1.0) (0.9)
Symptom
Group Day Day Day Day Day Day Day Day Day Day Day Day Day Day Day Day Day Day
0 30 60 0 30 60 0 30 60 0 30 60 0 30 60 0 30 60
WSE 125 mg QD 1.9 1.1 0.6 1.4 0.8 0.5 3.1 1.9 0.9 2.7 1.8 1.4 3.1 1.9 0.9 3.2 2.1 1.6
(n = 19) (0.8) (0.8)† (0.5)† (1.0) (0.8)† (0.6)† (0.9) (0.8)† (0.8)†‡ (0.7) (0.5)† (0.6)†‡ (0.7) (0.9)† (0.5)†‡ (0.5) (0.7)† (0.8)†‡
WSE 125 mg BID 2.2 0.9 0.6 1.5 0.7 0.4 3.1 1.9 1.0 2.8 1.8 1.2 3.4 1.9 0.8 3.3 1.6 0.8
† † † † † †‡ † †‡ † †‡ †
(n = 30) (1.1) (0.9) (0.6) (0.8) (0.7) (0.5) (1.0) (1.1) (0.8) (0.8) (0.8) (0.6) (0.6) (0.7) (0.6) (0.7) (0.8) (0.6)†‡
WSE 250 mg BID 2.2 0.8 0.6 1.5 0.4 0.0 3.2 1.6 0.5 2.8 1.1 0.9 3.2 1.7 0.4 3.1 1.5 0.5
† † † † † †‡ † †‡ † †‡ †
(n = 34) (1.1) (0.8) (0.7) (1.0) (0.7) (0.0) (1.1) (0.7) (0.7) (0.7) (0.5) (0.5) (0.7) (0.6) (0.6) (0.9) (0.7) (0.6)†‡
Placebo 2.2 2.1 1.9 1.5 1.5 1.4 2.7 2.7 2.7 2.8 2.5 2.5 2.7 2.8 2.9 3.0 3.0 3.0
(n = 15) (0.7) (0.7) (0.7) (0.9) (0.9) (0.7) (1.2) (1.2) (1.1) (0.4) (0.5) (0.5) (1.1) (1.1) (1.1) (0.9) (1.0) (0.9)
DHEAS = dihydroepiandrosterone sulfate; CRP = C-reactive protein; FBG = fasting blood glucose; TC = total cholesterol; TG = triglyc-
erides; LDL-C = low-density lipoprotein cholesterol; VLDL-C = very low-density lipoprotein cholesterol; HDL-C = high-density lipopro-
tein cholesterol. * P<0.05 versus Placebo Group, † P<0.001 versus Placebo Group, ‡ P<0.05 versus WSE 125 mg QD Group, # P<0.05
versus WSE 125 mg BID Group.
getfulness, irritability and inability to concentrate. The place- Figure 1. Mean sum (SD) total stress and anxiety scores
bo group did not display changes in mHAM-A score based on a modified Hamilton anxiety (mHAM-A) scalez by
throughout the study. Feelings of frustration that treatment group for Day 0 (baseline), Day 30 and Day 60 of treatment
was not helping their stress may have contributed to the high- with Withania somnifera extract (WSE) or placebo (n = 98).
er dropout rate in this group. The placebo group had nine par-
35
ticipants drop out due to lack of efficacy compared to three
for all WSE-treated groups combined (data not shown). 30
WSE’s therapeutic activity may be attributed, at least in
25
part, to its effect on the hypothalamic-pituitary-adrenal axis,
mHAM - A Score
concentration, which can be used as a marker of stress.30 In and 250 mg BID) reduced experiential feelings of stress and
the present study, the WSE-treated groups displayed anxiety, serum concentrations of cortisol and CRP, pulse
increased serum DHEAS concentrations by the end of the rate and blood pressure; and increased serum concentration
study, compared to the placebo group. The normalizing of DHEAS in the chronically stressed adults who complet-
action of WSE may also be due to neuroprotective proper- ed the study. The WSE 125 mg BID and WSE 250 mg BID
ties of withanolide glycosides and withaferin A that help dosages also improved fasting blood glucose levels and
reduce the stress-induced generation of reactive oxygen lipid profiles for study participants in those groups. Cardiac
species in various parts of the brain.22, 31-33 risk ratios improved for the two higher dosage WSE groups.
Chronic stress has been found to be associated with Although the 25% dropout rate may have partially skewed
higher than normal levels of serum CRP, a systemic marker results, the observed dose-dependent, significant trends in
of inflammation that is associated with increased risk for a most variables evaluated support the view that daily use of
host of chronic diseases.34 Use of WSE at all doses and fre- WSE would benefit people suffering from the effects of
quencies in this study resulted in a decrease in mean serum stress and anxiety without any adverse effects.
CRP concentration, indicating that systemic inflammation
may have declined in members of each WSE-treated group. ACKNOWLEDGMENT
Ingestion of WS root powder has decreased inflammation in
We would like to thank Natreon Inc. (New Brunswick,
animal models.35 Together these findings suggest that WSE
New Jersey) for financial support of this study.
use might contribute to decreased risk of chronic disease, an
idea meriting further investigation.
Reduction in fasting blood glucose concentration in the POTENTIAL CONFLICTS OF INTEREST
two highest dosage WSE-treated groups was also found. Dr. Auddy is an employee of Natreon Inc., which is the
This finding may be related to the observed concomitant patent holder of Withania somnifera extract sold under the
reduction in serum cortisol concentration. Cortisol is a glu- trade names Essentra® and Sensoril®.
cocorticoid hormone that performs several functions, Dr. Abedon is an employee of NutraGenesis LLC,
including regulation of blood sugar levels.36 which sells Withania somnifera extract exclusively under
the trade names Essentra® and Sensoril®.
CONCLUSIONS Dr. Ghosal was an unpaid adviser to Natreon Inc. at the
This study determined that daily consumption of stan- time the study was conducted.
dardized WSE at three dosages (125 mg QD, 125 mg BID,