A randomised comparative clinical study to evaluate the effectiveness of shirobasti and lalata basti with tungadrumadi taila in nidranasha (Primary Insomnia)
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- 2)Nasikotklesha
研究概览
简要总结
This study is an open label ,double arm randomised prospective clinical trial to evaluate the effectiveness of shirobasti and lalata basti with tungadrumadi taila in nidranasha(Primary Insomnia)that will be conducted in India.Primary outcome measures will be asya srava,nasikotklesha,karnasrava and secondary outcome measures will be assessed on the basis of relief in signs and symptoms of nidranasha which will be assigned suitable scores(Insomnia severity index scale)Time points will be before treatment after lalata basti after 15 days in subjects of Group A In Group B measures will be assessed before treatment after shirobasti after 15 days
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Open Label
入排标准
- 年龄范围
- 30.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Difficulty in falling asleep,maintain sleep or nonrefreshing sleep 2)Sleep disturbance occur atleast three times per week for atleast one month 3)Sleep disturbance results in marked personal distress or interferance with personal functioning in daily living.
排除标准
- •Known cases of alcoholism 2)Known cases of psychiatric illness 3)Previously diagnosed medical or surgical disorders 4)Patients suffering from ajeerna.
结局指标
主要结局
2)Nasikotklesha
时间窗: 1-2 weeks
1)Asya srava
时间窗: 1-2 weeks
3)Karnasrava
时间窗: 1-2 weeks
Samyak shirobasti lakshanas will be observed
时间窗: 1-2 weeks
次要结局
- The effect of therapy will be assessed on the basis of relief of following signs and symptoms of nidranasha which will be assigned suitable scores (Insomnia Severity Index Scale)(1)Jrimbha)