Efficacy of Yoga therapy (Yog Nidra) and Shirodhara in adults with Primary Insomnia – A Multi-Centric Randomized Controlled Trial
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- Improvement in Sleep quality and sleep duration is primary outcome. Modern medicine is having its own limitations. If it is taken for long duration, it may cause dependency. Insomnia cases may be successfully treated with alternative therapies like Shirodhara and Yognidra. Shirodhara may be most effective treatment for Insomnia. integrative approach may be beneficial for the improvement in Sleep Efficiency.
研究概览
简要总结
Present study aims to determine the efficacy of Yog Nidra or Shirodhara in the cases of primary insomnia. study will be conducted in four parallel groups- group 1- shirodhara, group 2- Yog nidra, group 3- Shirodhara + yog nidra, group 4- Etiozolam 0.25 mg od. all treatments will be given for 8 days. diary will be given to patient for note down observations from day-1 to day-15 regarding sleep Quality and time. finally results will be drawn based on observations.
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
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Newly diagnosed primary insomnia with complaints of sleep disturbances.
排除标准
- •secondary insomnia Pregnant women Chronic systemic disorders.
结局指标
主要结局
Improvement in Sleep quality and sleep duration is primary outcome. Modern medicine is having its own limitations. If it is taken for long duration, it may cause dependency. Insomnia cases may be successfully treated with alternative therapies like Shirodhara and Yognidra. Shirodhara may be most effective treatment for Insomnia. integrative approach may be beneficial for the improvement in Sleep Efficiency.
时间窗: first 7 days allotted therapy wlii be given (shirodhara/ yog nidra/ modern medicine) from 8 th day therapy will be stopped and patients only will maintain diary for noting observations regarding Sleep quality and duration up to 15 th day
次要结局
- integrative approach may be beneficial for the improvement in Sleep Efficiency.(15 days observations will be noted down)
研究者
GEETANJALI SAMBHAJI KARLE
AYUSH department, MUHS