CTRI/2022/04/042133已完成2 期
A randomized double-blind placebo-controlled study to determine the efficacy of ashwagandha extract on generalized anxiety disorder
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A)
研究概览
简要总结
Generalized anxiety disorder (GAD) is marked by excessive and exaggerated worry about everyday lifewithout an inducing event. The anxiety can dominate a person’s thinking so muchso that it affects his work and relationships, even his day-to-day activities. This double-blinded placebo-controlled study intends to study the efficacy of ashwagandha extract 60 and 120mg in the management of GAD. The primary outcome is the change in the HAMA from baseline to day 60. The study duration is 60 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Fulfilling the DSM –IV Criteria for Generalized Anxiety Disorder.
- •HAM-A total score > 20, Item 1 (anxious mood) ≥ 2, Item 2 (tension) ≥
- •Cortisol > 25 mcg/dl (morning (8– 9 am).
- •Clinical Global Impression-Severity of Illness (CGI-S) score ≥
- •Healthy subjects willing to give their informed consent.
排除标准
- •Montgomery-Asberg Depression Rating Scale (MADRS) total score greater than 12, with MADRS items 1 and 2 "apparent sadness" and "reported sadness†greater than or equal to
- •Current serious suicidal or homicidal risk, MADRS Item 10 (suicidal thoughts) score greater than 1 at the screening or randomization visit or a suicide attempt in the 6 months prior to screening.
- •Night shift workers (8 pm to 8 am)
- •Subjects who have not participated in a similar investigation in the past three months.
- •Alcohol dependence, chain-smoking, any psychedelic, narcotic substance abuse.
- •psychotic tendencies such as schizophrenia or taking any psychotropic medicines.
- •co-morbid illnesses such as cardiovascular, endocrine, renal, or other chronic diseases likely to affect stress/anxiety or limit normal function.
- •Positive pregnancy, breastfeeding, pregnancy planning.
- •Any serious acute or chronic medical condition that in the judgment of the investigator would make it inappropriate for the subject to participate in this study.
结局指标
主要结局
Change From Baseline in the Hamilton Rating Scale for Anxiety (HAM-A)
时间窗: Day 0 to Day 60
次要结局
- Change from Baseline in the HAM-A Score(From baseline to day 15, 30, & 45)
- Change from Baseline in CBC, RFT, LFT(From Baseline to days 0,30,60)
- Change from Baseline in the Cortisol level(From baseline to days 0,15,30,45,60)
- Change from Baseline in Clinical Global Impression scores(From baseline to days 0,30,60)
- Change from Baseline in PSS(From Baseline to days 0, 30, 60)
- Change from Baseline in PGIC(From Baseline to days 0, 30,60)
研究者
研究点 (1)
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