Conceptual study of Nidra and to evaluate the efficacy of "panchamuladi siddha dugdha" in management of Nidranasha (insomnia) due to excessive screen time in purview of "pushti swapn kranam".
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 入组人数
- 92
- 试验地点
- 1
- 主要终点
- Improvement in cardinal sign and symptoms of Nidranasha.
研究概览
简要总结
In the view of increasing incidences of insomnia because of increased screen time, it is the need of the hour to find a safe and effective solution to the problem. The conventional treatment modalities have their own limitations and cannot be used for longer time. So, this study has been planned to find an effective and safe management according to principles of Ayurveda.
The criteria for diagnosis and assessment of patient of Nidranasha due to excessive screentime will be Athens Insomnia Scale and self developed questionnaire.
Patients of age group 18 to 60 years irrespective of education , gender ,race, occupation will be divided into two groups(46 patients each group)using random number table.
Patients of Group A will be advised to take Panchmuladi( bhritpanchmula and balamula) ksheerpaka 100ml orally at night before bedtime for two months and
Patients of group B will be advised to take Nidanparivarjan (SOP will be provided) alongwith ksheerpaka for two months.
Within group(before versus after treatment) comparison will be done by Wilcoxon Signrank test.
And between group comparison will be done by Mannwhitney U test.
PRIMARY ENDPOINT will be Improvement in the Cardinal Sign and Symptoms of Nidranasha and to study in detail the concept of Nidra. SECONDARY ENDPOINT will be Improvement in the Quality Of
Life.
研究设计
- 研究类型
- Interventional
- 分配方式
- Random Number Table
- 盲法
- Open Label
入排标准
- 年龄范围
- 18.00 Year(s) 至 50.00 Year(s)（—）
- 性别
- All
入选标准
- •Patients with classical sign and symptoms of Nidranasha irrespective of race,gender,occupation, religion,caste and education.
- •People who are having problem in sleeping (insomnia) atleast three times per week during last month.
排除标准
- •Individuals with comorbidities like epilepsy, hypertension, diabetes, Asthma, tuberculosis, carcinoma, schizophrenia, psychosis and any other severe illness.
- •Individuals on any type of anxiolytic drugs, antidepressant therapy.
- •Pregnant women and lactating mother who are having any serious comorbidities like hypertension, diabetes.
- •Individuals doing travel and shift work.
- •People who are alcoholic, emotionally upset or stressed.
- •People who are undergone panchkarma procedures and raktmokshana during the assessment and recruitment People who are suffering from rheumatoid arthritis etc.
- •diseases having pain as a symptom.
结局指标
主要结局
Improvement in cardinal sign and symptoms of Nidranasha.
时间窗: 90 days
To study in detail the concept of Nidra.
时间窗: 90 days
次要结局
- Improvement in quality of life.(90days)