A comparative study to evaluate the efficacy of Shirodhara in the form of Takradhara and Snehadhara with Jatamansi oil in the management of Anidraw.s.r. 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
-  Final awakening earlier than desired.
研究概览
简要总结
This study is a randomizes, open, parallel group, interventional, prospective trial for comparing the effect of shirodhara in a group of 15 patients with Takra and another group of 15 patients with Jatamansi tail, which will be given for 14 days once daily at department of Panchkarma at Govt. Ayurvedic Medical College and Hospital at PATNA, Bihar and post intervention followup will be done after 14 days for the total duration of study of 28 days.
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
- 20.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients presenting with complaints of Reduction of sleep time
- •Difficulty in initiation of sleep, Patients fulfilling AIS scoring i.e., greater than 6 or equals to
- •Wakefulness during normal sleep.
- •Either any of the above or all of them for the duration of 3 months or more.
- •Patient of either sex in the age group of 20 – 70 years.
- •Willing to give informed consent.
排除标准
- •Disease like diabetes mellitus, cancer, AIDS, LVH, T.B. and other systemic disorder which leads fatal condition for patient.
- •Patient below 20 or above 70 years
- •Pregnant women and lactating mothers
- •Patient with stroke, haemorrhagic disorders, epilepsy or any other serious psychotic disorder
- •Patient with alcohol dependency or drug dependency.
- •Subjects who were having night jobs.
结局指标
主要结局
 Final awakening earlier than desired.
时间窗: 28 days
In 2 groups results of changes in signs and symptoms before and after treatment shall be observed and the same shall be recorded in the proforma of the case sheet prepared for the study.
时间窗: 28 days
 Athens Insomnia Scale (AIS)
时间窗: 28 days
 Sleep induction (time it takes you to fall asleep after turning-off the lights)
时间窗: 28 days
 Awakenings during the night.
时间窗: 28 days
 Total sleep duration,
时间窗: 28 days
 Overall quality of sleep (no matter how long you slept).
时间窗: 28 days
 Sense of well-being during the day.
时间窗: 28 days
 Functioning (physical and mental) during the day.
时间窗: 28 days
 Sleepiness during the day.
时间窗: 28 days
次要结局
- Yawning, lethargic, generalised body ache, anxious, headache, heaviness of head, heaviness of eyes, giddiness, Anorexia will be assessed.(28 days)
研究者
Dr Amrita Kumari
Govt. Ayurvedic Medical College and Hospital