| CTRI Number |
CTRI/2025/06/088924 [Registered on: 16/06/2025] Trial Registered Prospectively |
| Last Modified On: |
16/06/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Yoga on Helicobacter pylori induced Dyspepsia |
|
Scientific Title of Study
|
Yogic gut aeration for managing Helicobacter pylori induced Dyspepsia 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 |
Department of Yoga Science, Room No 1, Ground Floor,
Oriental Science Block
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 |
Department of Yoga Science, Room No 1, Ground Floor,
Oriental Science Block
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9634510540 |
| Fax |
|
| Email |
yogidrrudra@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Arti Saini |
| Designation |
Research Scholar |
| Affiliation |
University of Patanjali |
| Address |
Department of Yoga Science, Room No 1, Ground Floor,
Oriental Science Block
Hardwar
UTTARANCHAL
249405
India |
| Phone |
9719003766 |
| Fax |
|
| Email |
sainiarti1426@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Yoga Science, University of Patanjali, Haridwar-249405, Uttarakhand |
|
|
Primary Sponsor
|
| Name |
University of Patanjali |
| Address |
Department of yoga science, University of Patanjali, Haridwar, Uttarakhand -249405 |
| 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 Rohit Gupta |
AIIMS RISHIKESH |
Department of Gastroenterology
Dehradun
UTTARANCHAL |
971003766
docgupta1976@gmail.com |
|
|
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: K30||Functional dyspepsia, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional Medicine (PPIs and Antacids excluding antibiotics) |
Control group participants will take antacids or PPIs or both for three months as prescribed by the gastroenterologist of AIIMS Rishikesh |
| Intervention |
Loosening yoga poses and breath regulation practices followed by Yogic Gut Aeration (YGA) |
The proposed intervention will be given for 3 months, 5 days/week and 30-45 minutes each day. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of either gender with H. pylori induced dyspeptic clinical symptoms, aged 15-60 years and having willingness to yoga practice, and no other chronic illness/es, pregnancy, recent surgery and addictive behaviors will be included |
|
| ExclusionCriteria |
| Details |
1.Patients with upper gastrointestinal bleeding gastrointestinal malignancy, documented H.pylori eradication and other life-threatening conditions.
2.Dyspeptic patients with recent abdominal surgery, tonsillectomy, hypertension, pregnancy, severe spinal problems and other chronic illness.
3.Dyspeptic patients taking PPIs, NSAIDs or corticosteroids and H2 receptor antagonists or antibiotics with in 4 weeks preceding the intervention. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| changes in Inhibit H. pylori infection and reduce dyspeptic symptoms, addressing psychological and improving, QOL. |
At baseline (T0) and at 3 months (T1) |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="132"
Sample Size from India="132"
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)
|
01/07/2025 |
| 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="1"
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
|
50% of the global human population and over 20 million Indians are suffering from helicobacter pylori (H.pylori) infection.it may result in gastrointestinal disorder -dyspepsia different gastric ulcers, anemia, vitamin B12 deficiency, gastric atrophy, primary gastric B-cell lymphoma, etc. H.pylori is a microaerophilic bacterium found on the gastric epithelium, thriving in 5-15% Oxygen and inhabited when exposed to oxygen level equal to or higher than the atmospheric levels. Yogic gut Aeration techniques (YGAT). as described in Gherand Samhita, involve air ingestion, maneuvering into the gut and releasing as flatus. YGAT is proposed as a gut cleansing and detoxification method, potentially inhibiting H. Pylori and other microaerophilic/anaerobic in the gut and mitigating dyspepsia.
The study proposes a one-month RCT to assess the effects of YGAT on H.pylori inhibition, dyspepsia its symptoms, quality of life (QoL), and psychological comorbidities (depression , anxiety and stress), carbon-uera breath test (UBT), Gastrointestinal Symptoms Rating Scale (GSRS), Depression, Anxiety, Stress, Scale( DASS-21) and Quality of Life in Reflux and Dyspepsia (QOLRAD) will be used as measurement tools. A total of 132 participants will be enrolled and allocated to two groups: the experimental group and the control group in the study.
The data will be analyzed by using the Shapiro-Wilk test and split analysis of variance for between groups, within- group, and interactive effects, along with Bonferroni -adjusted post hoc analysis.
Primary outcomes include improvement in the C-UBT test and Dyspepsia after one month of intervention. Secondary outcomes include the improvement in dyspeptic symptoms, QoL, and psychological comorbidities (depression, anxiety and stress) after one month of intervention. |