To evaluate the combined efficacy of Jatamansi Churna sublingually along with Mahish Ghrit Padabhyanga in the management of Anidra w.s.r. to insomnia - an open labelled single arm clinical trial.
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Evaluation of the combined efficacy of Jatamansi Churna sublingually along with Mahish Ghrit Padabhyanga in the management of Anidra (Insomnia).
研究概览
简要总结
Anidra, or insomnia, is recognized as a disorder in Ayurvedic texts, associated with imbalances in bodily and mental doshas. Despite Ayurveda’s traditional use in treating insomnia, scientific validation of its efficacy is lacking, especially concerning specific treatments like Jatamansi churna and Mahish ghrit padabhyanga. This study seeks to bridge this gap by exploring the scientific basis of Ayurvedic interventions for insomnia. The study involves 40 individuals diagnosed with insomnia, who will receive Jatamansi churna and Mahish Ghrit Padabhyanga for a duration of 30 days. The study will monitor changes in their symptoms throughout the treatment period. Modern medicine often relies on medications like benzodiazepines for insomnia, which can have adverse effects and dependency issues. By investigating Ayurvedic approaches, this study aims to provide evidence for their effectiveness and promote their wider adoption. The research will focus on previously unexplored areas, including the sublingual route of administration and the combined efficacy of Jatamansi churna and Mahish ghrit padabhyanga. By shedding light on these aspects, the study aims to enhance understanding and acceptance of Ayurvedic practices in addressing insomnia, ultimately contributing to improved healthcare options and quality of life.
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 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patient with 3 or more symptoms of Anidra (primary insomnia).
- •Difficulty in initiating sleep.
- •Difficulty in maintaining sleep.
- •Primary insomnia such as insomnia without identifiable cause.
- •Recent changes in sleep pattern
- •Anidra with a history of a minimum of 2 week.
- •Insomnia Severity Index above a score of 7.
排除标准
- •K/C/O major psychiatric illness, chronic disease, and acute condition were excluded from the study.
- •Patients suffering from other systemic illnesses like CNS etc.
- •Chronic alcohol and caffeine users and drug dependents were also excluded from the study to achieve better results.
- •Patients who have night shift work schedules.
- •Drug-induced insomnia.
- •Pregnant or lactating women.
结局指标
主要结局
Evaluation of the combined efficacy of Jatamansi Churna sublingually along with Mahish Ghrit Padabhyanga in the management of Anidra (Insomnia).
时间窗: Baseline, Day 30
次要结局
- 1. Understanding the pathophysiology of Anidra from both Ayurvedic and modern perspectives.(2. Evaluating changes in subjective sleep quality.)
研究者
Dr Bansari M Kalsariya
Shree Swaminarayan Ayurvedic College, Kalol