CTRI/2024/05/067179已完成2/3 期
A single arm clinical study to evaluate the efficacy of an ayurvedic formulation in the management of Generalized Anxiety Disorder.
Dr. Nilang Rajnikant Bhimani1 个研究点 分布在 1 个国家目标入组 30 人开始时间: 2024年5月27日最近更新:
试验速览
- 阶段
- 2/3 期
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Reduction in generalised anxiety disorder symptoms
研究概览
简要总结
To study the efficacy of ayurvedic formulation in the management of generalized anxiety disorder (chittodvega) and total 30 patients will be enrolled and ayurvedic formulation of 500mg 2 vati in morning and evening will be given after food with ghee for duration of 28 days and follow up will be done on 14th and 28th day and final conclusion will be drawn on the basis of statistical methods.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients fulfilling the diagnostic criteria for the Anxiety Disorders as per DSM 5 Age group.
- •between 18 years to 70 years. Voluntarily participation in the clinical trial and agreeing to follow study procedures Not participating in any other interventional drug clinical studies before completion of the present study.
排除标准
- •Inability to intake or tolerate oral medications Pregnant or lactating women Patients with current or has a history of substance use disorder Patients having severe renal or hepatic impairment Patients who displayed marked suicidal intent or known suicidal tendencies Patient suffering from any psychiatric disorder other than GAD.
结局指标
主要结局
Reduction in generalised anxiety disorder symptoms
时间窗: 28 days study with 2 follow up (14 day and 28 | day)
Improvement in hamilton anxiety rating scale
时间窗: 28 days study with 2 follow up (14 day and 28 | day)
次要结局
- assess improvement in sleep through Insomnia Severity Index.(assess improvement in Quality of Life through ‘Quality of Life Enjoyment and Satisfaction Questionnaire’ (Q-LES-Q).)
研究者
Dr Nilang Rajnikant Bhimani
Dr. D. Y. Patil college of Ayurveda and Research center
研究点 (1)
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