Study to evaluate the effect of Padabhyanga and Bhramari Pranayama in Insomnia among the Middle-Aged People
试验速览
- 阶段
- 3 期
- 状态
- 招募中
- 发起方
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- It is expected that at the end of the study we would be able to assess the efficacy of Padabhyanga and Bhramari Pranayama in the management of Insomnia among middle- aged people by assessing the sleep quality of subjects with the help of Pittsburgh Sleep Quality Index and degree of Insomnia by Insomnia Severity Index before and after treatment
研究概览
简要总结
Sleep is one of the most significant human behaviour occupying roughly one-third of life. International Classification of Sleep Disorders-2 (ICSD-2) defined Insomnia as repeated difficulty with sleep initiation, duration, consolidation or daytime impairment. In Ayurveda Nidra has been explained as one of the upstambhas (triad) for sustaining life. In Ayurvedic literature Insomnia is explained by the term “Nidranash†or “Aswapnaâ€. Padabhyanga as a part of dincharya is said to induce sound sleep. Bhramari is one of the eight Pranayamas mentioned in Hathyogpradipika.
The study design is Randomized Controlled Clinical Study and sample will be selected by Simple Random Sampling method. Preffered age group is 30-60 years. Sample size will be 60 divided into study group and control group. Participants of study group will be intervened with Padabhyanga by Til Taila prior to bed and Bhramari Pranayama 10 counts in the morning and prior to bed. Participants of control group will be given 1 gm roasted semolina in capsule form prior to bed. Total intervention period will be of 30 days. The study will be conducted on the patients of OPD and IPD of Pt. Khushilal Sharma Government (Autonomous) Ayurveda College and Institute Bhopal. At the end of the study we would be able to assess the efficacy of Padabhyanga and Bhramari Pranayama in the management of Insomnia among middle-aged people.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 盲法
- Participant Blinded
入排标准
- 年龄范围
- 30.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Subjects aged between 30 – 60 years irrespective of their caste, race and sex etc.
- •Patients having symptoms of Nidranash (Insomnia) described in Ayurvedic and Modern literature.
- •Patients of Insomnia with mild hypertension, mild depression and anxiety disorder without any other major disorder.
- •Patients willing to fill informed consent form.
排除标准
- •Age below 30 and above 60 years.
- •Patients of fatal familial Insomnia.
- •Patients with known case of Diabetes Mellitus, Malignancy, Bronchial Asthma, Foot ulcer, Benign Prostate Hypertrophy, Psoriasis, Chronic Renal Failure and other systemic diseases Arthritis with severe pain.
- •Patients suffering from Middle ear infection.
- •People working in night shifts and people working in different time zone.
- •Patients having acute illness like Cardio-vascular accidents, Myocardial infarction and COPD.
- •Patients with alcohol and drug dependency.
结局指标
主要结局
It is expected that at the end of the study we would be able to assess the efficacy of Padabhyanga and Bhramari Pranayama in the management of Insomnia among middle- aged people by assessing the sleep quality of subjects with the help of Pittsburgh Sleep Quality Index and degree of Insomnia by Insomnia Severity Index before and after treatment
时间窗: 30 days
次要结局
- NA(NA)
研究者
Vijeta Raghuwanshi
Pt. Khushilal Sharma Government (Autonomous) Ayurvrda College and Institute,Bhopal,