CTRI/2025/05/086340尚未招募1 期
Randomized controlled trial to assess the efficacy of Pranayama and Shirodhara therapy in insomnia subjects
Institute of Medical Sciences BHU1 个研究点 分布在 1 个国家目标入组 100 人开始时间: 2025年6月5日最近更新:
试验速览
- 阶段
- 1 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Effect of pranayama and Shirodhara on sleep
研究概览
简要总结
This is an Randomized controlled study to analyse the effect of Pranayama and Shirodhara in 100 selected patients of Insomnia. This study aims to compare the efficacy of both procedures in insomnia.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- None
入排标准
- 年龄范围
- 18.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients Diagnosed with mild to moderate Insomnia based on DSM criteria -IV at the time of screening.
- •Habitual bedtime between 9:00 pm and midnight.
- •Able and willing to follow all study related instructions and to make all required visits.
- •Insomnia severity index score between 10-
- •5.The subjects who agreed to sincerely follow the instructions given during protocol were included in the study.
排除标准
- •4.6.1 Study related:
- •Patients with substance abuse (excluding tobacco, alcohol), severe depressive, psychotic or bipolar disorder with significant suicide risk.
- •Patient diagnosed other primary sleep disorders (Obstructive sleep apnea (OSA), Restless legs syndrome (RLS) and circadian rhythm sleep disorders etc.) will be excluded from study.
- •Patients having sleep schedule changes associated with shift work or night shifts in previous 7 days before study initiation or who intend to do the same during the study period.
- •Patients with clinically significant uncontrolled endocrine, metabolic, hepatic, renal, cardiovascular, gastrointestinal, respiratory, hematological or neurological illness.
- •Patients with history of malignancy, seizures or significant head trauma.
- •Pregnant or lactating women.
- •Patients in whom another investigational drug was used within three months prior to entry in this study.
- •Subjects otherwise judged by investigator or co- investigator to be inappropriate for inclusion in the study.
- •Those with age less than 18 yrs.
- •and more than 60 yrs.
- •Pranayama related:
- •Patient who are not able to sit comfortably for 20 minutes on ground due to any physical abnormality of pathology.
- •Patient not willing to follow the code of conduct of Yoga (Yama-Niyam)
- •Patients with marked deafness.
- •Patient not able to follow verbal instructions.
- •4.6.3 Shirodhara therapy related:
- •Central / peripheral neuropathy.
- •Patients having problems in lying supine for 1 hour.
- •Patients who cannot be relied upon to comply with the therapy procedures or are unwilling to give informed consent.
结局指标
主要结局
Effect of pranayama and Shirodhara on sleep
时间窗: Baseline, 9th days, 30th day
次要结局
- Effect of Pranayama and Shirodhara on quality of life of participants(After completing procedure for 9 days.)
研究者
Pawan Kumar Singh
Panchakarma Department Faculty of Ayurveda institute of medical Sciences Banaras Hindu University
研究点 (1)
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