Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) In Stress Disorders in Healthy Adults: A Prospective, Randomized, Double-Blind Placebo Controlled Study.

Shri Kartikeya Pharma0 个研究点目标入组 50 人开始时间: 待定最近更新: 2021年11月24日

试验速览

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•1.Adult male or female patients aged between 18 â?? 60 years of age
•2.Patients with routine work stress
•3.Patients stress disorders characterized with difficulty in concentration, physical exhaustion, anxiety, restlessness, insomnia, headache, fatigue, loss of appetite, phobia, sweating, mental confusion etc.
•4.Patients with Perceived Stress Scale (PSS) score more than or equal to 20 (high stress level)
•5.Body mass index between 25 and 39.9 kg/m2

•1.Participants who have a diagnosable eating disorder will also be excluded since intentional restriction of eating and binge eating/overeating could increase the variability of the data
•2.Currently (in the past three months) attending a weight loss program
•3.Underlying genetic or endocrine cause for weight gain
•4.Medications known to affect weight (corticosteroids, antidepressants, anti-psychotics, mood stabilizers, and anti-epileptic medications)
•5.History of Alcohol or smoking abuse
•6.Have clinically significant acute unstable hepatic, renal, cardiovascular or respiratory disease that will prevent participation in the study
•7.Patients with depressive episode, panic disorder, social phobia, obsessive-compulsory disorder; alcohol dependency; schizophrenia and mania
•8.Patients with post traumatic disorder
•9.Have an established practice of meditation for three or more months
•10.Pregnant and lactating women
•11.Subjects with known hypersensitivity to Ashwagandha
•12.Participation in other clinical trials during previous 3 months
•13.Any clinical condition, according to the investigator which does not allow safe fulfillment of clinical trial protocol

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