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临床试验/CTRI/2022/10/046160
CTRI/2022/10/046160尚未招募3 期

Effect of selected yoga techniques as an adjunct to vilwamoola khala and satwavajaya chikitsa in insomnia

Swathi Suresh1 个研究点 分布在 1 个国家目标入组 60 人开始时间: 2022年10月10日最近更新:

试验速览

阶段
3 期
状态
尚未招募
发起方
入组人数
60
试验地点
1
主要终点
Pittsburgh sleep quality index

研究概览

简要总结

Insomnia is a major public health problem and is the most common sleep disturbance in both adults and children. It is the difficulty in initiating and maintaining sleep or both, or the perception of poor sleep quality, in which the patient’s physical, psychological and social activities are interfered with, by a strong feeling of sleep deficiency upon waking in the morning. Insomnia is one among the 7 categories of sleep disorders in the International Classification of Sleep Disorders-3(ICSD-3(2020)).

In Ayurveda, nidra has been given prime importance and hence included in the tripods of life. So alteration in the natural process of nidra has a huge impact on the life processes as well. These alterations include nidranasa (complete loss of sleep), alpanidra (partial loss of sleep), nidradhikya (excess sleep) etc. Nidranasa, alpanidra, nidradhikya are vata, pitta, kapha nanatmaja vyadhis respectively. Clinical studies have proven the effect of use of vilwamoola khala and satwavajaya chikitsa as well as yoga in insomnia. This study is done with an intention to find out their add on effect.

A Quasi experimental study will be conducted in 60 participants of age group 20-60 years, satisfying the inclusion and exclusion criteria. Out of 60 participants, 30 will be consecutively selected and alternately allocated to study group (group 1) and control group (group2) . In Group 1 selected yoga techniques along with use of vilwamoola khala and satwavajaya chikitsa are done in insomnia. In Group 2, only use of vilwamoola khala and satwavajaya chikitsa are advised. The study period is for 30 days. Assessment will be done on 0th, 31st and 46th day using Pittsburgh sleep quality index & data analyzed accordingly.

研究设计

研究类型
Interventional
分配方式
Other
盲法
Not Applicable

入排标准

年龄范围
20.00 Year(s) 至 60.00 Year(s)(—)
性别
All

入选标准

  • Participants having difficulty in initiating and maintaining sleep.

排除标准

  • Participants with known severe systemic illness and other neurological illness.
  • Pregnant and lactating women.

结局指标

主要结局

Pittsburgh sleep quality index

时间窗: 0th,31th and 46th day

次要结局

未报告次要终点

研究者

发起方
Swathi Suresh
申办方类型
Other [Government Ayurveda Medical College ,Thiruvananthapuram]

研究点 (1)

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