| CTRI Number |
CTRI/2025/09/095256 [Registered on: 22/09/2025] Trial Registered Prospectively |
| Last Modified On: |
06/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
Modification(s)
|
Evaluating the Efficacy of Yoga as an Adjunct to Conventional Treatment on Symptomatic Relief and Mental Well-being in Patients with Gastroesophageal Reflux Disease |
|
Scientific Title of Study
|
EVALUATING THE EFFICACY OF YOGA AS AN ADJUNCT TO CONVENTIONAL TREATMENT ON SYMPTOMATIC RELIEF AND MENTAL WELL-BEING IN PATIENTS WITH GASTROESOPHAGEAL REFLUX DISEASE |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ankit Semwal |
| Designation |
Ph.D scholar |
| Affiliation |
School of Yoga Science, Swami Rama Himalayan University, Jolly grant, Dehradun, India |
| Address |
School of Yoga Science, Swami Rama Himalayan university Dehradun Uttarakhand India
Swami Rama Himalayan University Jolly grant Dehradun Uttarakhand India
Dehradun
UTTARANCHAL
248140
India |
| Phone |
07505277282 |
| Fax |
|
| Email |
vedicsystem53@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Somlata Jha |
| Designation |
Assistant Professor |
| Affiliation |
School of Yoga Science, Swami Rama Himalayan University |
| Address |
School of Yoga Science, Swami Rama Himalayan university JollyGrant Dehradun Uttarakhand India
Dehradun
UTTARANCHAL
248140
India |
| Phone |
9350641464 |
| Fax |
|
| Email |
somlatajha@srhu.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Dr Saurabh Singh |
| Designation |
Associate Professor |
| Affiliation |
Himalayan Institute of Medical Science, Swami Rama Himalayan, University |
| Address |
Department of Gastroenterology Swami Rama Himalayan University JollyGrant, Dehradun Uttarakhand India
Dehradun
UTTARANCHAL
248140
India |
| Phone |
8800178977 |
| Fax |
|
| Email |
drsingh.saurabh@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Gastroenterology Swami Rama Himalayan University |
|
|
Primary Sponsor
|
| Name |
Ankit Semwal |
| Address |
Swami Rama Himalayan University, Jolly grant, Dehradun, Uttarakhand, India |
| Type of Sponsor |
Other [Self] |
|
|
Details of Secondary Sponsor
|
|
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Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 1 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Saurabh SIngh |
Department of Gastroenterology |
Department of Gastroenterology Swami Rama Himalayan University
Dehradun
UTTARANCHAL |
8800178977
drsingh.saurabh@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Ethics Commitee, Swami Rama Himalayan University |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: K210||Gastro-esophageal reflux disease with esophagitis, |
|
Intervention / Comparator Agent
Modification(s)
|
| Type |
Name |
Details |
| Comparator Agent |
Conventional medical care for gastroesophageal reflux disease |
Medicines include 1) proton pump inhibitors, 2) Alginates, 3) prokinetics, 4), and 5) laxative
Frequency & Total Duration:
Medications will be administered daily as prescribed by the treating physician. The treatment duration is expected to be up to 12 weeks, depending on the patient’s response and clinical management. Some patients may discontinue or adjust medication after 8 weeks based on symptom improvement and physician’s advice. |
| Intervention |
Yoga |
A structured, integrated yoga protocol to conventional treatment for patients with gastroesophageal reflux disease (GERD)
The intervention comprises a specific set of yoga practices aimed at improving GERD symptoms, reducing stress, and enhancing quality of life.
The Yoga protocol includes:
1) Diaphragmatic breathing, as mentioned in the (Swami Rama Himalayan tradition), for 5 minutes.
2) Nadi Shodhan pranayama, as mentioned in the (Swami Rama Himalayan traditional) for 5 minutes.
3) Bhramari Pranayama, as mentioned in the (Traditional yoga text "Gheranda Samhita ") for 5 minutes with pauses.
4) Systematic relaxation, as mentioned in the (Swami Rama Himalayan tradition), for 15 minutes.
5) Soham meditation, as mentioned in the (Swami Rama Himalayan tradition), for 5 minutes.
The overall intervention consists of 35 minutes, 6 days per week, for 12 weeks.
Intervention will be delivered both in-person and through tele-yoga for participants unable to attend physically, ensuring proper follow-up.
A structured, integrated yoga protocol to conventional treatment for patients with gastroesophageal reflux disease (GERD). The intervention comprises a specific set of yoga practices aimed at improving GERD symptoms, reducing stress, and enhancing quality of life. Intervention will be delivered both in-person and through tele-yoga for participants unable to attend physically, ensuring proper follow-up.
Frequency & Total Duration:
The intervention will be conducted 6 days per week, with each session lasting 35 minutes.
Intervention duration will be 12 weeks
|
|
Inclusion Criteria
Modification(s)
|
| Age From |
18.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Individuals diagnosed with erosive GERD
2.Subjects between the age group of 18 between 70
3. Both literate and illiterate
4. participants who consume alcohol occasionally
|
|
| ExclusionCriteria |
| Details |
1. Patients diagnosed with non-erosive reflux disease
2. Subjects who have recently undergone any thoracic and abdominal surgery
3. Patients diagnosed with Barretts esophagus
4. Patient with a diagnosis of liver cirrhosis
5. Individuals with current or past or current diagnoses of any form of malignancy
6. An individual consuming alcohol cigarettes and other drugs
7. An individual having medication that triggers GRED like calcium channel blocker beta blockers etc
8. Patients with large hiatal hernia Grade 3 and Grade 4
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Outcome Assessor Blinded |
Primary Outcome
Modification(s)
|
| Outcome |
TimePoints |
| Gerd Symptoms using GERDQ questionnaire |
Baseline and final assessment after 12 weeks |
|
Secondary Outcome
Modification(s)
|
| Outcome |
TimePoints |
1 Stress by PSS-10
2 Quality of life by GERD-HRQL |
Baseline & final assessment after 12 weeks |
|
|
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 1/ Phase 2 |
|
Date of First Enrollment (India)
|
10/10/2025 |
| 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="8"
Days="30" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Yet Recruiting |
| 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
Modification(s)
|
Title of the Study:
Evaluating the Efficacy of Yoga as an Adjunct to Conventional Treatment on Symptomatic Relief and Mental Well-Being in Patients with Gastroesophageal Reflux Disease (GERD) Type of Study:
Randomized Controlled Trial (Parallel Group Design) Study Design and Randomization:
This is a 12-week, randomized, parallel controlled study with two groups. A total of 120 participants will be enrolled, with 60 patients in each group. Randomization will be carried out using a computer-generated block randomization list. Allocation concealment will be maintained through the snoSEAL (sealed envelope) method. Study Groups: Group A (Intervention Group): Yoga-based intervention (specific yoga protocol) + Conventional medical treatment for GERD. Group B (Control Group): Conventional medical treatment alone. Sample Size:
120 participants (60 in each group). Study Setting:
The study will be conducted in the Department of Gastroenterology, Himalayan Institute of Medical Sciences (HIMS), Swami Rama Himalayan University, Dehradun, Uttarakhand, India. Follow-up and Assessments: Baseline and post-intervention assessments (after 12 weeks) will be done using standardized tools such as GERD-Q, GERD-HRQL, and Perceived Stress Scale (PSS). Intervention group will follow a structured yoga protocol (35 minutes/day, 6 days/week, for 12 weeks) including diaphragmatic breathing, Nadi Shodhan, Bhramari, systematic relaxation, and meditation. Primary Outcome Measures: Reduction in GERD symptoms (measured by GERD-Q) Secondary Outcome Measures: 1. Reduction in stress levels (PSS). 2. Improvement in quality of life (GERD-HRQL) |