| CTRI Number |
CTRI/2024/06/068429 [Registered on: 06/06/2024] Trial Registered Prospectively |
| Last Modified On: |
31/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
Effect of Yoga on Chronic Insomnia |
|
Scientific Title of Study
|
Clinical assessment of Trataka and Nada Yoga on Anidra (Chronic Insomnia) |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ayushi Dwivedi |
| Designation |
Ph.D Scholar |
| Affiliation |
Banaras Hindu University |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University.
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
8318125459 |
| Fax |
|
| Email |
ayushidwivedi997@bhu.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Parameswarappa S Byadgi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Parameswarappa S Byadgi |
| Designation |
Professor |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9450711759 |
| Fax |
|
| Email |
psbyadgi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Vikriti Vigyan, Faculty of Ayurveda, Institute of Medical Sciences, Banaras Hindu University, Varanasi,Uttar Pradesh India 221005 |
|
|
Primary Sponsor
|
| Name |
Head Department of Vikriti Vigyan |
| Address |
Department of Vikriti Vigyan Faculty of Ayurveda Institute of Medical Sciences Banaras Hindu University Varanasi Uttar Pradesh Indian 221005 |
| 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 |
| Ayushi Dwivedi |
Sir Sunderlal Hospital |
Room no.23 Indian Medicine Wing Institute of Medical Sciences Banaras Hindu University Varanasi
Varanasi
UTTAR PRADESH |
8318125459
ayushidwivedi997@bhu.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| The Ethics Committee, Institute of Medical Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: G470||Insomnia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control Group |
Therapeutics prescribed by the Doctor as per the
requirement of the patient for 60 Days |
| Intervention |
Nadayoga |
Nadayoga for 20 minutes for 60 Days |
| Intervention |
Trataka |
Trataka for 20 minutes for 60 Days
|
| Intervention |
Trataka and Nadayoga |
Trataka and Nadayoga for 45 minutes together for 60 Days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
55.00 Year(s) |
| Gender |
Both |
| Details |
All subjects who have complain of Chronic Insomnia will be registered aged
between 18-55 years
Patients who fulfilled the diagnostic criteria for Chronic Insomnia
Both men and women
The patient who is willing to participate in the research work after giving
informed written consent in a predesigned proforma. |
|
| ExclusionCriteria |
| Details |
Patients less than 18 and more than 55 years will be excluded
Pregnant women
Patients who are unable to do yoga practices |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To evaluate the effect of Trataka and Nadayoga in the management of Anidra
Chronic Insomnia |
60 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assessment of Epworth Sleepiness Scale Insomnia Severity Index Hamilton Anxiety
Scale Hamilton Depression Scale before and after the Trataka and Nadayoga
Assessment of Sattwabala Pariksha on Anidra Chronic Insomnia |
60 Days |
|
|
Target Sample Size
|
Total Sample Size="140"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "Applicable only for Completed/Terminated trials"
Final Enrollment numbers achieved (India)="Applicable only for Completed/Terminated trials" |
|
Phase of Trial
|
Phase 3 |
|
Date of First Enrollment (India)
|
15/06/2024 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
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
|
A total of 140 patients suffering from chronic Insomnia will be selected and will be randomly divided into four groups. first group will receive Trataka second group will receive Nadayoga third group will receive Trataka and Nadayoga and fourth group will receive modern medicine for 60 days. the data will be analyzed to evaluate the effect of Trataka and Nadayoga in the management of Anidra (Chronic Insomnia) in comparison to modern medicine. |