Comparative clinical study to evaluate the efficacy of Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia
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
- The drug may help to bring Improvement in sleep Quality and duration
研究概览
简要总结
Title: Comparative Clinical Study to evaluate the efficacy of Gud-Pippalimool tablet and Ashwagandha Tablet in the Management of Nidranash w.r.t Insomnia
Aim: To compare the efficacy of Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia.
Objectives: 1. To study the effect of Gud-Pippalimool tablet in management of Insomnia. 2. To study insomnia in detail according to Ayurveda and modern science. 3. To compare the effects of Gud-Pippalimool tablet and Ashwagandha tablet in the management of insomnia.
Research Questions: Primary Research Question - Is Gud-Pippalimool tablet effective in the management of Nidranash w.r.t Insomnia? Secondary Research Question - Is the effect of Gud-Pippalimool tablet significant than Ashwagandha tablet in the management of Nidranash w.r.t Insomnia?
Hypothesis: H0: There will be no significant difference between Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia. H1: There will be significant difference between Gud-Pippalimool tablet and Ashwagandha tablet in the management of Nidranash w.r.t Insomnia.
Materials: Group A (Gud-Pippalimool tablet) - Contents: Pippali, Pippali Mool and Gud (Jaggery). Group B (Ashwagandha Tablet) - Contents: Ashwagandha churna, Sita (sugar) and Sarpi (ghee).
Drug Administration: Gud-Pippalimool tablet 2gm HS with water for 28 days by oral route and Ashwagandha tablet 2gm HS with water for 28 days by oral route.
Methods: Study Design - Two arms, Open labelled, Randomized and Controlled clinical study.
Assessment Criteria: Subjective Criteria
| Symptom |
0 Grade
1 Grade
2 Grade
3 Grade
|Jrumbha
Never
Occasionally
Periodically
Always
|Angamarda
Never
Occasionally
Periodically
Always
|Tandra
Never
Occasionally
Periodically
Always
|Shirogaurav
Never
Occasionally
Periodically
Always
- Pittsburgh Sleep Quality Index (PSQI)
Statistical Analysis:
-
All observation will be noted in the observation table.
-
Depending upon observation, Statistical analysis will be done by appropriate test.
-
Efficacy of Subjective criteria will be analyzed by Wilcoxon rank sum test.
-
Efficacy of Objective criteria will be analyzed by paired t-test.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 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
- •1-Patients complaining of difficulty in falling asleep, frequent or sustained awakenings and early morning awakenings.
- •2-patients suffering from insomnia from one month or above.
排除标准
- •1-Patients with major psychiatric illness like schizophrenia, depressive psychosis, epilepsy, etc 2-Patients with drug dependency.
- •3-Women in their pregnancy and lactation.
- •4-Chronic alcoholic patients.
- •5-Diabetic patients.
结局指标
主要结局
The drug may help to bring Improvement in sleep Quality and duration
时间窗: total 28 days study | Follow up on 14th day 28th day & 14 days | after the completion of treatment.
次要结局
- NA(NA)
研究者
Dr Tanya Bhawnani
Padmashree Dr DY Patil School of Ayurveda , Nerul ,Navi Mumbai