| CTRI Number |
CTRI/2025/08/093756 [Registered on: 27/08/2025] Trial Registered Prospectively |
| Last Modified On: |
27/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Ayurveda
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Yoga for managing IBS-C |
|
Scientific Title of Study
|
Integral yoga intervention for managing constipation predominant irritable bowel syndrome: a randomized controlled trial |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Rudra Bhandari |
| Designation |
Associate Professor |
| Affiliation |
University of Patanjali |
| Address |
Office of Dr Rudra Bhandari, Room no.1, ground floor,Department of yogic science, University of Patanjali, Delhi-Haridwar Highway, Patanjali Yogpeeth-I,Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Rudra Bhandari |
| Designation |
Associate Professor |
| Affiliation |
University of Patanjali |
| Address |
Office of Dr Rudra Bhandari, Room no.1, ground floor,Department of yogic science, University of Patanjali, Delhi-Haridwar Highway, Patanjali Yogpeeth-I,Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prabhu Narayan Kushawaha |
| Designation |
PhD scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of yogic science, University of Patanjali, Delhi-Haridwar Highway, Patanjali Yogpeeth-I,Bahadrabad, Haridwar
Hardwar
UTTARANCHAL
249405
India |
| Phone |
7536044982 |
| Fax |
|
| Email |
dr.pnk57@gmail.com |
|
|
Source of Monetary or Material Support
|
|
Department of yoga science, University of Patanjali, Haridwar, Uttarakhand -249405, India |
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Delhi-Haridwar Highway, Patanjali Yogpeeth-I, Haridwar, 249405, Uttarakhand, India |
| Type of Sponsor |
Other [Private University] |
|
|
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 Girish KJ |
Patanjali Bhartiya Ayurvigyan Evam Anusandhan Sansthan |
Patanjali Ayurveda Hospital, Patanjali Yogpeeth phase-1, Bahadrabad.
Hardwar
UTTARANCHAL |
944 64 6855
girideepa@yahoo.co.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee, University of Patanjali |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition:K581||Irritable bowel syndrome with constipation. Ayurveda Condition: GRAHANIDOSHAH, |
|
|
Intervention / Comparator Agent
|
| sno | Intervention/Comparator | Type | Drug-Type | Procedure Name | Details | | 1 | Intervention Arm | Drug | Classical | | (1) Medicine Name: Abhyaristha, Reference: Bhaishajyaratnavali-Arsharogadhikara, Route: Oral, Dosage Form: Arishta, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -(2) Medicine Name: Triphala, Reference: Charak samhita- Rasayan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: (3) In addition to the above medication, participants in the intervention arm will receive an Integral yoga module comprising Shatkarma,asana,Pranayam, mudra, bandha, meditation, and naad yoga, administered for 60 minutes/day, 6 days/week, over 3 months. | | 2 | Comparator Arm | Drug | Classical | | (1) Medicine Name: Abhyaristha, Reference: Bhaishajyaratnavali-Arsharogadhikara, Route: Oral, Dosage Form: Arishta, Dose: 30(ml), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: -(2) Medicine Name: Triphala, Reference: Charak samhita- Rasayan, Route: Oral, Dosage Form: Gutika/Vati/Ghana Vati/ Tablets, Dose: 1000(mg), Frequency: bd, Bhaishajya Kal: Adhobhakta, Duration: 3 Months, anupAna/sahapAna: Yes(details: luke warm water), Additional Information: Can be taken as churna or powder form. |
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
1. Patient diagnosed with IBS-C, based on ROME-IV criteria.
2. Not enrolled in any other alternatives medicine programs.
3. Committed for 3 Months interventions and follow up procedures. |
|
| ExclusionCriteria |
| Details |
i. Patients with other medical issues like DM, HTN, Thyroid, kidney, heart and liver diseases, etc.
ii. Severe psychiatric disorders, physical and mental disability to do yoga.
iii. Patient’s history of drug, alcohol, or chemical abuse within 6 months prior to screening.
iv. Inability to comply with study and follow up procedures.
v. Pregnant and lactating women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Change in IBS Symptom Severity Score (IBS-SSS) |
At baseline (T0) and at 3 months (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Changes in quality of life (IBS-QOL), gastrointestinal cognition and health, fear of food and visceral sensitivity of IBS-C Patients. |
At baseline (T0) and at 3 months (T1) |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
15/09/2025 |
| 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="6"
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
|
Slow moving stool in the intestine often becomes dehydrated creating hard stool, which can exacerbate symptoms of constipation and this type of constipation predominant is the most common type, affecting nearly 50% of people with IBS. Stool transit time may be sped up or slowed down due to a disruption in communication between the brain and the intestine. Assuming that the syndrome may have general autonomic control as the main player in etiopathogenesis, we considered studying the efficacy of integral yoga interventions on symptoms severity, gastrointestinal health, quality of life, visceral sensitivity, gastrointestinal cognition and fear of food like parameters in constipation predominant IBS patients. It will provide insights into the benefits for integrating yoga intervention for other diseases too to foster holistic health in patients. The finding could inform both educational practices and health policies aimed at enhancing overall health of the people. |