CTRI/2024/07/071043已完成2/3 期
A Randomized comparative Clinical Study to evaluate the efficacy of Japa pushpa Churna and Karnapoorana with Ksheerabala Taila in the management of Anidra vis-a-vis Insomnia
Dr Deepu CN1 个研究点 分布在 1 个国家目标入组 40 人开始时间: 2024年8月10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
- 40
- 试验地点
- 1
- 主要终点
- Reduction in the symptoms of Insomnia is assessed using Insomnia Severity Index Scale
研究概览
简要总结
This study is a randomized, comparative clinical trial to evaluate the efficacy of Japa pushpa churna (Hibiscus rosa sinensis) 3gms twice daily and Karnapoorana with Ksheerabala taila for 100 matra kala (2 mins 24 secs) in Group A with minimum of 20 subjects , placebo and Karnapoorana with Ksheerabala taila for 100 matra kala (2mins 24 secs) in Group B with minimum of 20 subjects in the management of Anidra vis-a-vis Insomnia for a period of 30 days. The primary outcome is improving the sleep quality and the secondary outcome is improving the quality of life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects who fit to the diagnostic criteria Subjects suffering from Insomnia occurrin atleast 3 times a week for one month Subjects who fit for karnapoorana Subjects willing to provide informed consent Subjects who arer under any medication interfering with the current study but has discontinued one month prior to the study.
排除标准
- •Subjects with any systemic diseases and medications which interfere with the disease process and present clinical trial will be excluded Subjects with major psychiatric illness like schizophrenia, epilepsy, depressive psychosis will be excluded Insomnia due to substance abuse and trauma will be excluded Physiological conditions like pregnancy, lactation and puerperal stage will be excluded Subjects planning for conception will be excluded.
结局指标
主要结局
Reduction in the symptoms of Insomnia is assessed using Insomnia Severity Index Scale
时间窗: 15th and 30th day
次要结局
- Improvement in induction & maintainence of the sleep using Insomnia Severity Index Scale(15th day & 30th day)
研究者
Dr Deepu CN
Sushrutha Ayurvedic medical college and hospital
研究点 (1)
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