Effectiveness of a polyherbal churn formulation of Bramhi, Shankhpushpi and Vacha compared to Tagar churn in the management of Anidra (Primary insomnia):A Randomised Controlled Clinical Trial
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 80
- 试验地点
- 1
研究概览
简要总结
This study will be carried out at OPD and IPD of Kayachikitsa Department of Pakwasa Samanvay Rugnalaya, Shri Ayurved Mahavidyalaya, Nagpur.
This is a double-blind randomized controlled trial aims at studying the comparison between polyherbal churna formulation of bramhi shankhpushpi and vacha with tagar churna in management of Anidra (primary insomnia.)
A total of 80 patients will be included and will be randomly allocated to two treatment groups using Stratified block randomization method i.e. Group A and Group B each containing 40
patients. Group A will be trial group, where patients will receive polyherbal churna(bramhi , shankhapushpi and vacha )and Group B will be the control group, where patients will receive Tagar Churna. Then patients will be
observed on 7th, 15th, and 30th day. All the findings will be recorded in case record form. At the end of trial, collected data will be analyzed and results will be drawn accordingly.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients aged between 18 and 60 years
- •Diagnosed cases of Primary Insomnia based on Diagnostic and Statistical Manual of Mental Disorders-Fifth Edition (DSM-IV)
- •AIS score more than or equal to 6 at baseline.
- •Duration of insomnia more than or equal to 1 month
- •Willingness to participate and provide written informed consent.
排除标准
- •Secondary insomnia due to psychiatric disorders (e.g., depression, anxiety) or medical conditions.
- •History of substance abuse or sedative use within the past 2 weeks.
- •Severe hepatic, renal, or cardiovascular illness.
- •Pregnant or lactating women.
- •Known allergy to trial drugs or their components.
- •Known case of Lactose Intolerance.
研究者
Dr Nikita Gajanan Deulkar
Shri Ayurved Mahavidyalaya, Nagpur