| CTRI Number |
CTRI/2023/08/056821 [Registered on: 23/08/2023] Trial Registered Prospectively |
| Last Modified On: |
19/08/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
To Evaluate the Effect of Integrated yoga and Herbal drug compound in the management of Insomnia (Anidra) |
|
Scientific Title of Study
|
Evaluation of Integrated Yoga and Herbal Drug Compound in the Management of Anidra (Insomnia) |
| Trial Acronym |
NA |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Vijay Shanker Yadav |
| Designation |
PhD Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Dhanwantri Bhawan, Department of Sangyaharan, Faculty of Ayrveda, IMS BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9455050889 |
| Fax |
|
| Email |
VIJAYSHANKERAHIR89@GMAIL.COM |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Bhola Nath Maurya |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Sangyaharan Dhanwantri Bhawan Institute of Medical Science Banaras Hindu University
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9415447600 |
| Fax |
|
| Email |
bnmaurya@bhu.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Bhola Nath Maurya |
| Designation |
Assistant Professor |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Sangyaharan Dhanwantri Bhawan Institute of Medical Science Banaras Hindu University
UTTAR PRADESH
221005
India |
| Phone |
9415447600 |
| Fax |
|
| Email |
bnmaurya@bhu.ac.in |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Banaras Hindu University |
| Address |
IMS, BHU, Varanasi |
| Type of Sponsor |
Government medical college |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Bhola Nath Maurya |
Sir Sundar Lal Hospital |
Room No. 15, Dept.of Sangyaharan,
Varanasi
UTTAR PRADESH |
9415447600
bnmaurya@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:F99||Mental disorder, not otherwise specified. Ayurveda Condition: NIDRANASAH/ASVAPNAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Lifestyle | - | - | Dinacarya: na, Ritucarya: na, Acara Rasayana:na, Other:, Pathya/Apathya:no, Pathya:, Apathya: | | 2 | Comparator Arm (Non Ayurveda) | | - | Yoga | Specific Physical, Breathing, and Meditation intervention will be given | | 3 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Compound of Nardostachys Jatamansi and Tagar, Reference: Dravyaguna Vijnana 2nd Volume, Prof. P.V. Sharma, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 300(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: No, Additional Information: - |
|
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1. People with insomnia.
2. Who can write, read and understand Hindi or English.
3. Age range between 18 and 50 years.
4. Both genders.
5. Willing to participate in the study |
|
| ExclusionCriteria |
| Details |
1. Participants suffering from chronic diseases will be excluded.
2. Individuals with a history of neurologic disease.
3. Known case of psychiatric disease.
4. Those who are unable to perform yogic practices.
5. Those who take medicine of another disease. |
|
|
Method of Generating Random Sequence
|
Stratified randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
The Pittsburgh Sleep Quality Index (PSQI)
Insomnia Severity index |
3 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| total sleep time (TST), sleep efficiency |
3 months |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="0" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
01/09/2023 |
| Date of Study Completion (India) |
Date Missing |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
In this study we are focusing on Evaluating the effect of Yoga on Insomnia and the side effects of Insomnia. We are using Ayurveda Medicine as a comparator arm for the study. |