A single blind randomized controlled clinical study to evaluate the combined efficacy of Ksheerabala taila pichu with Mamsyadi kwatha and Sahadevi taila pichu with Simhimuladi kwatha in Anidra with special reference to Primary Insomnia
试验速览
- 阶段
- 4 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Reduction of sign and symptoms like Jrumbha, Tandra,
研究概览
简要总结
Sleep has a restorative function and is important for conservation of energy and growth. In Ayurveda, Nidra is considered as an important component of Trayopastambha i.e Ahara, Nidra, and Bramhacharya. This aphorism of Acharya Charaka shows the necessity of Nidra. Acharya Charaka stated that happiness and misery, stoutness and thinness, strength and debility, virility and impotence, knowledge and ignorance as well as life and death all are depends on sleep.
Persistent insomnia can leads to impairment of day time functioning, injury due to accidents and the development of major depression. Insomnia is associated with substantial impairment in an individuals quality of life. Various risk factors associated with increased prevalence of chronic insomnia including older age, female gender and comorbid medical and psychiatric conditions.
Increasing age predisposes to sleep disorders (5% incidence in persons aged 30-50 years and 30% in those aged 50 years or older). people who are elderly experience a decrease in total sleep time, with more frequent awakenings during night. Elderly persons also have higher incidence. Hormonal variations during menstrual cycle or during menopause may cause disruption in sleep.
The surveys provide estimates of the prevalence of Insomnia based on insomnia criteria as defined by the DSM (Diagnostic and Statistical Manual of Insomnia)-4 recognises that about 1/3rd of general population presents at least one of them. When daytime consequences of insomnia are taken into account, the prevalence is between 99% - 15%, 8 18% of general population are having sleep dissatisfactions.
研究设计
- 研究类型
- Interventional
- 分配方式
- Coin toss, Lottery, toss of dice, shuffling cards etc
- 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 presents with symptoms like Jrumbha, Tandra, Angamarda, Klama, Shiroshula and sign and symptoms of Primary Insomnia like difficulty initiating/maintaining sleep, sleep interruption, reduction in sleep time, daytime fatigue since 1 month.
- •2.Subjects of age group 30-60 years.
- •3.Subjects of both genders.
- •4.Subjects fit for Pichukarma.
- •5.Subjects who willing to participate and gives written consent.
排除标准
- ••Subjects with cancer, heart disease, asthma, gastroesophageal reflux disease, thyroid disease, parkinsons disease, alzheimers disease, sleep apnea and restless leg syndrome.
- ••Subjects with psychiatric illness like schizophrenia, major depressive disorder, psychosis, epilepsy and anxiety disorders.
- ••Subjects with chronic liver and kidney disorders.
- ••Subjects with diabetes and hypertension.
- ••Pregnant women and lactating women.
- ••Subject with alcohol dependency and drug dependence.
- ••Those who are working in night shifts.
结局指标
主要结局
Reduction of sign and symptoms like Jrumbha, Tandra,
时间窗: 30 days
Angamarda, Klama, Shiroshula of Anidra with special reference to Primary Insomnia.
时间窗: 30 days
次要结局
- Improvement in the scores of Athens Insomnia Scale (AIS)(45 days)
研究者
Dr Ashwini Deshmukh
Shri DGM ayurvedic medical college, kalsapur road, shivanand nagar Gadag. 582103