A Double Blind, placebo controlled, Clinical study to evaluate the efficacy and safety of Ashwagandha in stress disorders
试验速览
- 阶段
- Unknown
- 状态
- 已完成
- 入组人数
- 50
- 试验地点
- 2
- 主要终点
- Efficacy of Ashwagandha caplets in stress disorders in
研究概览
简要总结
In this Double Blind, placebo controlled, randomized study, ashwagandha extract caplets are evaluated clinically versus placebo for efficacy and safety in patients with stress disorders. Otherwise normal male/female patients above 18 years of age presenting with Mild to moderate stress disorders characterized with Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion are included in the study after obtaining informed consent. Symptoms assessed are difficulty in concentration, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion. Assessment done on a 0-10 VAS. The overall clinical assessment is defined as cured, improved and unchanged.
研究设计
- 研究类型
- Observational
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •Mild to moderate stress disorders characterized with Difficulty in concentration, Physical exhaustion, Anxiety, restlessness, insomnia, Headache, fatigue, loss of appetite, Phobia, Sweating, mental confusion etc.
- •Age >18 years, both male and female subjects.
- •Hematologic and Biochemical parameters within normal limits.
排除标准
- •Patients with severe Psychiatric conditions.
- •Pregnant & Breast feeding Women.
- •Patients with severe Hepatic/ cardiac/ mental illness.
- •History of Alcohol or smoking abuse.
- •Patients unwilling to provide informed consent or abide by the requirements of the study.
结局指标
主要结局
Efficacy of Ashwagandha caplets in stress disorders in
时间窗: 90 days
providing rapid symptomatic recovery
时间窗: 90 days
次要结局
- Safety of Ashwagandha caplets in stress disorders(Provide rapid symptomatic recovery)