Randomized, Open Labelled, Clinical Trial Of Mansyadi Kashay In The Management Of Nidranasha w.s.r. To Stress Induced Insomnia In Control With Ashwagandha Churna
试验速览
- 阶段
- 2/3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes in clinical features of Anidra (Insomnia) will be recorded before and after the treatment based on Improvement in SEI scoring Index.
研究概览
简要总结
Study of the effect of the Mansyadi kashay (Jatamansi 540gm, Ashwagandha 1260gm, Parasik yavani 460gm) in patients suffering from stress induced insomnia fulfilling the inclusion criteria and comparing with Ashwagandha churna with Mahishi dugha anupan administration on randomly selected 120 patients. Total 120 patients will be enrolled for the study each patient will be given medication for a period of 15 days.
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
- 25.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Stressful life causing insomnia.
- •patients with SEI score were selected.
- •Willing to participate in study and ready to sign an informed consent.
排除标准
- •Patient with other systemic disorders Patient with alcohol dependency or drug dependency.
- •Patient under Hypnotic medication, drug abuse Physiological conditions like pregnancy, lactation and puerperal stage.
结局指标
主要结局
Changes in clinical features of Anidra (Insomnia) will be recorded before and after the treatment based on Improvement in SEI scoring Index.
时间窗: Pittsburgh Sleep Quality Index Score and Insomnia Severity INDEX Score will be assessed in questionnaire form at screening visit, baseline visit 0th, 7th, 16th, 30th day.
次要结局
- The comparison of before and after improvement in symptoms like Angamarda ( Bodyache), Shiroguarav ( Heaviness in Head), Jrimbha ( yawning), Jadya ( Heaviness in body), Bhrama( Giddiness), Apakti (Indigestion), Nidra ( Sleep)(The comparison of before and after improvement in symptoms)
研究者
Dr Abhilasha Chatragun Lagad
Dr. D.Y.Patil college of Ayurved and Reasearch centre, Sant Tukaram Nagar, Pimpri,Pune