| CTRI Number |
CTRI/2024/04/066369 [Registered on: 26/04/2024] Trial Registered Prospectively |
| Last Modified On: |
16/04/2024 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy
Screening |
| Study Design |
Other |
|
Public Title of Study
|
Mental Health benefits of Yoga |
|
Scientific Title of Study
|
Effect of Yoga on Stress, Depression, Anxiety and Insomnia-an Interventional study across Punjab. |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Kamlesh Kumar Mishra |
| Designation |
Yoga Consultant |
| Affiliation |
Guru Ravidas Ayurved University Punjab Hoshiarpur |
| Address |
Guru Ravidas Ayurved University Punjab,Una Road Hoshiarpur
Punjab
"CM Di Yogshala"
Medical Educational Bhawan
sector 69 SAS nagar Mohali
Punjab
Hoshiarpur
PUNJAB
146110
India |
| Phone |
9560437000 |
| Fax |
|
| Email |
yogikamlesh@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Kamlesh Kumar Mishra |
| Designation |
Yoga Consultant |
| Affiliation |
Guru Ravidas Ayurved University Punjab Hoshiarpur |
| Address |
Guru Ravidas Ayurved University Punjab,Una Road Hoshiarpur
Punjab
"CM Di Yogshala"
Medical Educational Bhawan
sector 69 SAS nagar Mohali
Punjab
Hoshiarpur
PUNJAB
146110
India |
| Phone |
9560437000 |
| Fax |
|
| Email |
yogikamlesh@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Kamlesh Kumar Mishra |
| Designation |
Yoga Consultant |
| Affiliation |
Guru Ravidas Ayurved University Punjab Hoshiarpur |
| Address |
Guru Ravidas Ayurved University Punjab,Una Road Hoshiarpur
Punjab
"CM Di Yogshala"
Medical Educational Bhawan
sector 69 SAS nagar Mohali
Punjab
Hoshiarpur
PUNJAB
146110
India |
| Phone |
9560437000 |
| Fax |
|
| Email |
yogikamlesh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Data collection, Investigation,
and Yog practice from CM Di Yogshala,Camp office Mohali,Punjab,INDIA,PIN-160062 |
|
|
Primary Sponsor
|
| Name |
Guru Ravidas Ayurved University |
| Address |
Una Road, Kharka
Hoshiarpur Punjab
146110 |
| Type of Sponsor |
Research institution |
|
|
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 |
| Kamlesh Kumar Mishra |
Guru Ravidas Ayurved University Punjab, Una Road, Hoshiarpur ,Punjab |
Room No.10,CM Di Yogshala
Admin Block
Hoshiarpur
PUNJAB |
9560437000
yogikamlesh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee of Guru Ravidas Ayurved University Punjab Hoshiarpur |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
, (1) ICD-10 Condition: F411||Generalized anxiety disorder, (2) ICD-10 Condition: F413||Other mixed anxiety disorders, (3) ICD-10 Condition: F413||Other mixed anxiety disorders, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NA |
NA |
| Intervention |
YOGA Activities |
Period of Study: 6 month
Sukhsham Vyayam, Aasana Paranayam. Meditation,
ShadKriya et.
these process will be done as per patients condition. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
a) Individuals screened positive for Stress
Depression Anxiety and Insomnia.
b) Individuals who gives consent. |
|
| ExclusionCriteria |
| Details |
a) Individuals on medication for any Psychiatric
illness.
b) Individuals having chronic Physical Disease.
c) Individuals not have intellectual disability.
d) Individuals who are not able to follow up for 3
months
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Significant reduction in Serum Cortisol levels |
zero day,90th day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To see the efficacy of Yoga in people coming to CMDY in cities of Punjab having stress, depression, anxiety and insomnia |
zero day,30th day,60th day,90th days |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
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 2 |
|
Date of First Enrollment (India)
|
15/08/2024 |
| 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="0"
Months="3"
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 - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
Response - Statistical Analysis Plan
Response - Informed Consent Form
Response - Clinical Study Report
Response - Analytic Code
- Who will be able to view these files?
Response - Anyone
- For what types of analyses will this data be available?
Response - Any purpose.
- By what mechanism will data be made available?
Response - Data are available indefinitely at (Link to be included www.graupunjab.org).
- For how long will this data be available start date provided 07-04-2024 and end date provided 03-07-2024?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - N/A
|
|
Brief Summary
|
SUMMARY Background- Due to exhausting fast pace of life, stress has become an integral part of our lives. It further leads to various physical and psychiatric disorders. Contrarily Yoga has been proven to be beneficial in improving our overall health. Novelty- Doing a non-psychopharmacological intervention like Yoga alone in people have stress, depression, anxiety and insomnia in various cities of Punjab having ‘C.M di Yogshala (CMDY)’ initiative. Objective- Primary objective- To see the efficacy of Yoga in people coming to CMDY in cities of Punjab having stress, depression, anxiety and insomnia. Methods- 100 people (25 each) suffering from depression, anxiety, stress and insomnia shall be consecutively enrolled in study from different cities having CMDY. DASS-21 (21 itemed depression, anxiety and stress scale) will be applied to diagnose depression, anxiety and stress. To diagnose insomnia, Insomnia Severity Index (ISI) shall be used. To further confirm diagnosis of depression, anxiety and insomnia, International Classification of Diseases 10th edition for mental health and behavioral disorders (ICD-10) shall be used. For confirming stress serum cortisol levels will be analyzed. Above mentioned scales shall be applied at baseline and at 3 months after intervention is over. Yogic intervention will be provided by trained Yoga instructors daily for 1 hour for 3 months. Data will be analyzed statistically on SPSS-22.0. Expected outcome- Yoga should improve the over-all quality of life. It should lower the scores of depression, anxiety and stress on DASS-21; it should also lower insomnia on ISI, including Serum Cortisol Levels. |