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
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 60
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1. Fulfilling the DSM –IV Criteria for Generalized Anxiety Disorder.
- •2. HAM-A total score > 20, Item 1 (anxious mood) = 2, Item 2 (tension) = 2.
- •3. Cortisol > 25 mcg/dl (morning (8– 9 am).
- •4. Clinical Global Impression-Severity of Illness (CGI-S) score = 4.
- •5. Healthy subjects willing to give their informed consent.
排除标准
- •1. 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 2.
- •2. 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.
- •3. Night shift workers (8 pm to 8 am)
- •4. Subjects who have not participated in a similar investigation in the past three months.
- •5. Having psychotic tendencies such as schizophrenia or taking any psychotropic medicines.
- •6. Alcohol dependence, chain-smoking, any psychedelic, narcotic substance abuse.
- •7. psychotic tendencies such as schizophrenia or taking any psychotropic medicines.
- •8. co-morbid illnesses such as cardiovascular, endocrine, renal, or other chronic diseases likely to affect stress/anxiety or limit normal function.
- •9. Positive pregnancy, breastfeeding, pregnancy planning.
- •10. 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.
研究者
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