Clinical Evaluation Of Jyotishmati Taila Nasya And Ashwagandha Root Extract In Sleep Onset Insomnia W.S.R. To Nidra Nasha
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 100
- 试验地点
- 1
- 主要终点
- Relief in Signs and Symptoms and significant improvement of subjective parameters, teststo 50% baseline
研究概览
简要总结
A clinical trial will be done to evaluate the efficacy of Jyotishmati taila nasya and ashwagandha root extract orally in the management of Insomnia vis-a-vis Nidra Nasha and to validate scientifically the observations that would significantly change the signs and symptoms of Insomnia. Nasya is a unique procedure for urdhwa jatrugata rogas which is mentioned in several ayurvedic texts like Charaka Samhita and Susruta Samhita and will be performed on 50 patients with Jyotishmati Tailam which has a reference from Bhavaprakasa along with Ashwagandha root extract 500 mg oral administration for 40 days. The study would be conducted in India aimed to complete in 3 years and the trial time being 21 months. Primary out-come measures will be relief in signs and symptoms(Subjective Parameters)
研究设计
- 研究类型
- Interventional
- 分配方式
- Adaptive randomization, such as minimization
- 盲法
- Open Label
入排标准
- 年龄范围
- 20.00 Year(s) 至 60.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients of age group 20-60 years, irrespective of gender, with symptoms like disturbed sleep, fatigue, heaviness of head, heaviness of body and frequent yawning, with no hormonal imbalances.
排除标准
- •Patients age less than 20 years, more than 60 years, with chronic illnesses, drug addicts, alcoholics, psychiatric patients, pregnant and lactating mothers.
结局指标
主要结局
Relief in Signs and Symptoms and significant improvement of subjective parameters, teststo 50% baseline
时间窗: Treatment period of 40 days with follow up at 15-40-60-90 days with active follow up of 3 months
次要结局
- Relief in Signs and Symptoms and significant improvement of Objective parameters(Treatment period of 40 days with follow up at 15-40-60-90 days with active follow up of 3 months)