Efficacy And Safety of KSM66 Ashwagandha (Withania somnifera) In Stress Disorders in Healthy Adults: A Prospective, Randomized, Double-Blind Placebo Controlled Study.
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 1
- 主要终点
- Improvement from baseline in Perceived Stress Scale score (PSS) after 8 weeks.
研究概览
简要总结
This studyis A prospective, randomized, double-blind,placebo-controlled study to compare the efficacy of Ashwagandha in stressdisorder in healthy adults. A total of 50 healthy adults subjects will be recruited in this study. Adult maleor female subjects between 18 to 60 years of age, with routine work stress, stress disorders characterized with difficultyin concentration, physical exhaustion, anxiety, restlessness, insomnia, headache,fatigue, loss of appetite, phobia, sweating, mental confusion etc. ,Perceived Stress Scale (PSS) score more than or equal to 20 and Body mass indexbetween 25 and 39.9 kg/m2 will beenroll in study. Study duration will be 8 weeks for each subject with baseline,week 4 & week 8 visits. Subjects were asked to take 1 capsule two timesdaily (total 2 capsules per day) with water daily for 8 weeks. At the end of study primaryoutcome will be assessed as Improvement from baseline in Perceived Stress Scalescore (PSS) after therapy and secondary outcome as improvement from baseline inthe score for Oxford Happiness Scale and urine cortisol level. Change inWeight, vital signs and Body mass index (BMI) andabsolute and percentage weight loss will be compared after therapy.Safety willbe assessed by evaluation of adverse events reported by the patients during thestudy and Global assessment of tolerability will be performed by physician atthe end of study.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Adult male or female patients aged between 18 – 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.
排除标准
- •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.
结局指标
主要结局
Improvement from baseline in Perceived Stress Scale score (PSS) after 8 weeks.
时间窗: 8 weeks
次要结局
- Change in Weight(baseline, week 4 and week 8)
- Body mass index (BMI) and absolute and percentage weight loss will be compared.(8 weeks)
- Improvement from baseline in the score for Oxford Happiness Scale after therapy(baseline, week 4 and week 8)
- Improvement from baseline in urine cortisol level(baseline, week 4 and week 8)
- Change from baseline in vital signs(8 weeks)