A Clinical Study to Evaluate The Effect of Sarpagandha Ghana Vati in the Management of Chronic Insomnia
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- To improve the time of falling asleep, improve staying asleep and improve waking up after 7 hours
研究概览
简要总结
Insomnia is the most common sleep disorder in the world. It is approximated that 10-15% of adults in the general world population suffer from chronic insomnia.Studies show that abnormal sleep patterns such as insomnia predict lower life expectancy and are more prone to affective disorders, and substance abuse. Elderly people, women, people with mental and physical disorders, those of lower socioeconomic status, night shift workers, and unemployed persons are all consistent risk factors for insomnia. Nidra is one of the Trayopastambha of Ayurveda, with Nidranasha leading to Dukkha (misery), Karshya (emaciation), and Abalam (loss of strength). It also leads to Klaibya (infertility) and Ajnanam (loss of mental efficiency). As such, the quality of life for a patient is impacted leading to diseases and other lifestyle disorders. Conventional medicine principles for chronic insomnia incorporate cognitive behavioural therapy in conjunction with pharmacological intervention such as benzodiazepines and ramelteon. In the usage of benzodiazepines, 15-40% of long-term users report having severe withdrawal symptoms after cessation, even after only a few weeks of treatment. Sarpagandha Ghana Vati is a classical formulation referred in Siddha Prayoga Sangraha. Therefore, research on efficacious, convenient formulations that ensure a healthy maintenance of sleep is the need of the hour. Hence, A Clinical Study to Evaluate the Effect of Sarpagandha Ghana Vati in the Management of Chronic Insomnia was undertaken.
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
- 18.00 Year(s) 至 70.00 Year(s)（—）
- 性别
- All
入选标准
- •18 to 17 years old irrespective of age socioeconomic class gender religion or caste Patients that meet the International Classification of Diseases 11th Edition criteria for chronic insomnia disorder Patient with a history of insomnia more than 3 months long.
排除标准
- •Patients younger than 18 years old and older than 70 years old Patients with insomnia symptoms less than 3 months long Patients diagnosed with major systemic diseases such as liver diseases and kidney diseases Patients with a history of substance abuse Patients diagnosed with clinical anxiety disorders clinical depression schizophrenia and bipolar disorder Patients suffering from visceral pain Patients on other medications for insomnia Pregnant and lactating mothers Patients with chronic hypotension below 100 by 60 mmHg.
结局指标
主要结局
To improve the time of falling asleep, improve staying asleep and improve waking up after 7 hours
时间窗: This improvement is to be observed over a time period of 30 days, with a mid-trial assessment on the 15th Day, imemdiate post-trial assessment on the 31st Day, and a follow up assessment on the 46th Day.
次要结局
未报告次要终点
研究者
Dr Meghana Nambiyur
Sri Jayendra Sarawathi Ayurveda College and Hospital