Clinical evaluation of A comprehensive Ayurvedic intervention in Manodwega (Generalized Anxiety Disorder)
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Primary Outcome Measure
研究概览
简要总结
This study is a randomized parallel group clinical trial assessing the efficacy of Ashwagandha (Withania Somnifera) and Mandukaparni (Bacopa Monerii) in 3gm dose per day (1.5gm BID) in group I, and along with these medicines Shirodhara (Pouring of medicated herbal oil on the forehead for 30 minutes ) with Ksheerabala taila in Group II. The intervention period for internal medicines is 12 weeks in both the groups and Shirodhara in Group II will be during first 7 days. The study centre is Advanced centre for Ayurveda in Mental health and neurosciences, NIMHANS campus Bangalore. The primary objective is assessment of the safety and efficacy of intervention in terms of changes in HRS for Anxiety in Manodwega (GAD patients). Shirodhara is an Ayurvedic treatment procedure in which medicated oils are poured in a stream on the fore head for a period of 30 minutes. It is having effects like improving concentration, induces sleep and has a tranquilizing effect.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 45.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Age between 18 to 45 years of either sex 2.Diagnosed Cases of GAD Based on DSM IV diagnostic criteria for Generalized Anxiety Disorder 3.Willing to give written informed consent for the participation.
排除标准
- •1.Age less than 18 years and more than 45 years.
- •2.Depression 3.Social phobias 4.Hypertension 5.Cardiac diseases 6.Epilepsy 7.Asthma and COPD 8.Hyperthyroidism 9.Diabetes 10.Alcoholics and Drug addicts.
结局指标
主要结局
Primary Outcome Measure
时间窗: Periodically once in 4 weeks till 12 weeks duration
To assess improvement in total Hamilton anxiety rating scale
时间窗: Periodically once in 4 weeks till 12 weeks duration
次要结局
- Secondary Outcome Measure(To observe change in individual components of Hamilton anxiety rating scale)