A Standardized Withania Somnifera Extract Significantly Reduces Stress-Related Parameters in Chronically Stressed Humans: A Double-Blind, Randomized, Placebo-Controlled Study
Notes for this study:
|Values||Hamilton’s Anxiety Rating Scale. Placebo: before 1.5 (0.9), after 1.4 (0.7). 125 mg: before 1.4 (1.0), after 0.5 (0.6). 250 mg before 1.5 (0.8), after 0.7 (0.7). 500 mg before 1.5 (1.0), after 0.0 (0.0).|
|Trial Design||Randomized trial|
|Trial Length||1-6 months|
|Number of Subjects||130|
|Age Range||18-29, 30-44, 45-64|
In a randomized, double-blind, placebo-controlled trial, 130 participants with an anxiety disorder were assigned to take 125 mg, 250 mg, or 500 mg of ashwagandha extract containing a minimum of 8% withanolide glycosides, 32% oligosaccharides, and a maximum of 2% withaferin A for 60 days.Funding issues for this study:
32 participants dropped out, with more dropouts in the placebo group. While the placebo group saw no notable changes, the ashwaganda groups all saw statistically significant improvements compared with the placebo group in stress/anxiety, fatigue, flushing, perspiration, loss of appetite, headache and muscle pain, feelings of impending doom, palpitations, dry mouth, sleeplessness, forgetfulness, irritability, and inability to concentrate. The 250 mg and 500 mg groups seemed to be somewhat more potent than the 125 mg group for stress/anxiety, fatigue and inability to concentrate.
Serum cortisol, CRP and serum VLDL-C, and blood pressure were statistically significantly reduced compared with placebo in all ashwagandha groups, and DHEAS was significantly increased. Fasting blood glucose, total serum cholesterol, serum triglycerides, LDL-C, and HDL-C were improved in the 250 mg and 500 mg groups compared with placebo, and the 500 mg group was significantly lower than the 125 mg group for all but CRP and fasting blood glucose.
"We would like to thank Natreon Inc. (New Brunswick, New Jersey) for financial support of this study. "
"Dr. Auddy is an employee of Natreon Inc., which is the patent holder of Withania somnifera extract sold under the
trade names Essentra® and Sensoril®. Dr. Abedon is an employee of NutraGenesis LLC, which sells Withania somnifera extract exclusively under the trade names Essentra® and Sensoril®. Dr. Ghosal was an unpaid adviser to Natreon Inc. at the
time the study was conducted."