| CTRI Number |
CTRI/2026/02/103854 [Registered on: 13/02/2026] Trial Registered Prospectively |
| Last Modified On: |
12/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A trial to study the effect of Yoga in Ulcerative colitis patients. |
|
Scientific Title of Study
|
To study the effectiveness of standard medical therapy with yoga compared to standard medical therapy for the treatment of mild to moderate ulcerative colitis. A randomized control study |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| Nil |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Gourav Sahu |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
House No. 1011, Sector 15B, Chandigarh
Department of Gastroenterology, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
8966030146 |
| Fax |
|
| Email |
sahu.gourav15@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Gourav Sahu |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
House No. 1011, Sector 15B, Chandigarh
Department of Gastroenterology, PGIMER Chandigarh
Chandigarh
CHANDIGARH
160015
India |
| Phone |
8966030146 |
| Fax |
|
| Email |
sahu.gourav15@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Gourav Sahu |
| Designation |
Senior Resident |
| Affiliation |
PGIMER Chandigarh |
| Address |
House No. 1011, Sector 15B, Chandigarh
Department of Gastroenterology, PGIMER Chandigarh
CHANDIGARH
160015
India |
| Phone |
8966030146 |
| Fax |
|
| Email |
sahu.gourav15@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Nil |
| Address |
Nil |
| Type of Sponsor |
Other [Nil] |
|
|
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 |
| Gourav Sahu |
PGIMER Chandigarh |
Department of Gastroenterology, PGIMER Chandigarh
Chandigarh
CHANDIGARH |
08966030146
sahu.gourav15@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, PGIMER Chandigarh |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K519||Ulcerative colitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Standard therapy |
Patients will receive the standard of care of ulcerative colitis in comperator arm.
Steroids/5-ASA/Tofacitinib |
| Intervention |
Yoga + Standard therapy |
In addition to standard of care conventional IBD treatment, intervention participants will receive Yoga. The 12 week Hatha Yoga intervention include 2 components : (i) Physical postures (Cat cow, yoga namaskar, tree, thunderbolt, Yogi squat, yoga namaskar in goddess, Triangle, Seated twist, Happy baby, reclining twist, wind removing pose, Beauty pose, Locust pose) for 30 minutes per day for atleast 5 days a week and (ii) Breathing techniques ( Diaphragmatic breathing, alternate nostril breathing, sitali) for 15 minutes per day for atleast 5days a week. |
|
|
Inclusion Criteria
|
| Age From |
19.00 Year(s) |
| Age To |
85.00 Year(s) |
| Gender |
Both |
| Details |
1. Patients with age more 18 years
2. Diagnosed cases of UC by endoscopy and biopsy.
3. Patients with mild to moderate disease.
|
|
| ExclusionCriteria |
| Details |
1. Patients in remission
2. Patients having toxic megacolon
3. Patients with Crohn’s disease, microscopic colitis, and celiac disease
4. Patients with uncertain diagnosis
5. Patients with infectious colitis and exposure to radiation
6. Patient unwilling to participate in study
7. Lactating and pregnant females
8. Patients with suspected or proven malignancy of any organ and GI malignancy
9. Patients with severe co-morbidities
10. Previous history of venous thromboembolism.
11. Patients undergoing major surgery.
12. History of prolonged immobilisation.
13. Myocardial infarction (within previous 3 months)/Heart failure
|
|
|
Method of Generating Random Sequence
|
Stratified block randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The proportion of subjects in remission at the end of week 12. |
The proportion of subjects in remission at the end of week 12. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
The proportion of subjects achieving mucosal healing at Week 12.
Clinical response at 12weeks.
change in inflammatory biomarkers. |
At 12weeks |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
25/02/2026 |
| 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="1"
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 - NO
|
|
Brief Summary
|
Current study will be conducted to assess the role of yoga in mild to moderate ulcerative colitis patients. |