Clinical evaluation of Nidrakar Churna and Shiropichu with Ksheerbala Taila in Anidra (Insomnia)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- 1. Improvement in Insomnia Severity Index (ISI) score
研究概览
简要总结
This is an open-label, single-arm clinical study to evaluate the efficacy of Nidrakar Churna (oral) and Shiropichu with Ksheerbala Taila in the management of Anidra (Insomnia). A total of 60 patients fulfilling DSM-5 criteria for insomnia will be enrolled from the OPD of Kayachikitsa, Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan, Haridwar. The intervention will be administered for 60 days, with assessments at day 1, day 30, and day 60. Primary outcomes will be measured using classical Ayurvedic parameters and the Insomnia Severity Index (ISI) scale. The study aims to provide an effective and safe Ayurvedic therapeutic approach for insomnia.
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 having classical symptoms of Anidra such as Tandra, Angamarda, Jrumbha, Arati, Klama, Shirashoola and Akshigaurava
- •Patients fulfilling DSM V Criteria for Insomnia
- •Both new and previously treated cases will be included
- •Patients aged between 18 and 70 years
- •Patients of either gender irrespective of their race, occupation, religion and socio economic status
- •Patients who will be capable and willing to adhere to all study related instructions, attend all scheduled visits and sign the consent form.
排除标准
- •Physiological conditions like pregnancy, lactation and puerperal stage
- •History of any acute systemic pathological illness such as fever in the preceding one month
- •Patients with insomnia comorbid with other medical conditions
- •Patients with impaired Renal, Hepatic or Cardiac function
- •Patients having drug or alcohol dependency
- •Exaggeration of previous psychiatric illness such as major depression and mania
- •Use of hypnotics or other therapies for insomnia within the past 4 weeks.
结局指标
主要结局
1. Improvement in Insomnia Severity Index (ISI) score
时间窗: Day 1, Day 30, Day 60
2. Improvement in Ayurvedic symptom grading (Tandra, Akshigaurava, Shirashoola, Angamarda, Arati, Klama, Jrumbha)
时间窗: Day 1, Day 30, Day 60
次要结局
- Safety and tolerability of the intervention(Day 1, Day 30, Day 60)
研究者
KANIKA
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan