Effect of milk prepared by boiling coarse powder of herbal drugs(i.e. Brihat Panchmula and Balamula) in it, on people having problem in sleeping/disturbed sleep quality and quantity due to excessive use of gadgets/screens(e.g computer, mobile, tablet,television) especially during night.
- Conditions
- Insomnia. Ayurveda Condition: निदà¥à¤°à¤¾à¤¨à¤¾à¤¶,
- Registration Number
- CTRI/2022/01/039793
- Lead Sponsor
- All India Institute Of Ayurveda
- Brief Summary
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.
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Not Yet Recruiting
- Sex
- All
- Target Recruitment
- 92
- 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.
- 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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Improvement in cardinal sign and symptoms of Nidranasha. 90 days To study in detail the concept of Nidra. 90 days
- Secondary Outcome Measures
Name Time Method Improvement in quality of life. 90days
Trial Locations
- Locations (1)
All India Institute Of Ayurveda, New Delhi
🇮🇳South, DELHI, India
All India Institute Of Ayurveda, New Delhi🇮🇳South, DELHI, IndiaVd Priyanshu ChauhanPrincipal investigator9711360088priyanshuchauhan028@gmail.com