To determine the efficacy of an Ayurvedic formulation INS00l in treating Insomnia disorder A pilot feasibility study
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 30
- 试验地点
- 1
- 主要终点
- Improvement in Sleep duration and Sleep quality.
研究概览
简要总结
Insomnia is a major public health problem and sleep disturbance is most common 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. The expected outcomes are to evaluate the efficacy of Tablet INS001 in patients suffering from Insomnia and to evaluate the sleep quality of individuals under Ayurveda medication. The outcome measure would be the psychometric assessment of sleep quality using PSQI comparing Pre vs Post intervention.
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 60.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Male and Female participant above 18 to 60 years of age and willing to give written inform Consent.
- •2.Perceived total sleep time of more than 6 hours per night 3.Patient with history of self-reported primary insomnia or with diagnosis of primary insomnia (as defined by the Diagnostic and Statistical Manual for Mental Disorders-IV.
排除标准
- •1.Female who are pregnant, breast feeding or not willing to use adequate contraception during the course of the study.
- •2.Patient with psychiatric illness or concomitant disorder or any other condition that could potentially disturb or have impact on sleep.
- •3.Patients using tobacco products or caffeinated beverages during night awakenings.
- •4.Patients on any medication for insomnia.
- •5.Patients using any sedative hypnotic drugs including benzodiazepines, non-benzodiazepine synthetic drugs, herbal and OTC products.
- •6.Patients working in night shifts within 5 days of screening or intended to do so during the course of the study.
- •7.Patients with history of alcohol abuse or drugs abuse.
- •8.Patients who were using any other medication that are known to influence sleep but could not be withdrawn.
- •9.Patients who are participated in another investigational drug had been used within three months prior to screening in this study.
- •10.Patients who could not be relied upon to comply with the study procedures.
结局指标
主要结局
Improvement in Sleep duration and Sleep quality.
时间窗: Day0,Day15,Day30.
次要结局
- To evaluate the sleep quality of individuals under Ayurveda medication.(Day0,Day15,Day30.)
研究者
Dr Yogeshwar Chippa
Sri Sri Institue of Advanced Research