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CTRI Number  CTRI/2018/12/016506 [Registered on: 03/12/2018] Trial Registered Prospectively
Last Modified On: 18/01/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Yoga & Naturopathy
Preventive
Screening
Behavioral
Other (Specify) [Quality of life]  
Study Design  Randomized, Parallel Group, Placebo Controlled Trial 
Public Title of Study   Yoga for Acid Peptic Diseases 
Scientific Title of Study   Yogic Gut Aeration Techniques to Inhibit Helicobacter Pylori Induced Acid Peptic Diseases 
Trial Acronym   
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  Assistant Professor 
Affiliation  University of Patanjali 
Address  B-2O1,Sankardeh Vanprasth Ashram,near Patanjali Yoga Peeth,Phase-2.
Room no-416, 3rd floor,department of yoga science,University of Patanjali,Phase-1,Haridwar,Uttarakhand,249405.
Hardwar
UTTARANCHAL
249405
India 
Phone  9634510540  
Fax  -  
Email  rbap@uop.edu.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Rudra Bhandari 
Designation  Assistant Professor 
Affiliation  University of Patanjali 
Address  B-2O1,Sankardeh Vanprasth Ashram,near Patanjali Yoga Peeth,Phase-2.
Room no -416, 3rd floor,department of yoga science,University of Patanjali,Phase-1,Haridwar,Uttarakhand,249405.
Hardwar
UTTARANCHAL
249405
India 
Phone  9634510540  
Fax  -  
Email  rbap@uop.edu.in  
 
Details of Contact Person
Public Query  
Name  Rohini Dayma 
Designation  PhD Scholar 
Affiliation  University of Patnajali 
Address  D- 403, seva sadan,near patanjali yoga peeth, phase-2,haridwar.
Room no-416, 3rd floor,department of yoga science,University of Patanjali,Phase-1,Haridwar,Uttarakhand,249405.
Hardwar
UTTARANCHAL
249405
India 
Phone  8368413241  
Fax    
Email  rdyoga46@gmail.com  
 
Source of Monetary or Material Support  
University of Patanjali 
 
Primary Sponsor  
Name  Vice Chancellor  
Address  University of Patanjali,pahse-1,Haridwar,Uttrakhand- 249405. 
Type of Sponsor  Other [University of Patanjali] 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Rohini Dayma  Patanjali Ayurved Hospital  Patanjali Ayurved Hospital,phase-1,Haridwar,Uttrakhand-249405.
Hardwar
UTTARANCHAL 		 8368413241

rdyoga46@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: K296||Other gastritis,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NIL  NIL 
Intervention  Yogic Gut Aeration Techniques  1)loosening practices: to prepare the body for yogic practices for 15 min. 2)Manduki mudra (through mouth) for 5 min. 3)Kaki mudra to injest air through mouth, for 15 min. 4)Inveted postures (shashank asana, viprit karni asana) 2 round each.It may take 15 Min. 5)Rest (shavasana) 5 min. Total duration of the therapy is 55 min/day (six days per week for the duration of three months). 
 
Inclusion Criteria  
Age From  20.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  H. pylori induced APDs(GERD, hyperacidity,1st stage ulcer.Subjects with positive H.Pylori test and score > 27 in the GSRS(Gastrointestinal Symptom Rating Scale). 
 
ExclusionCriteria 
Details  Patients with: tonsillectomy, recent abdominal surgery, and pregnancy hypertension,Severe spinal problems or other chronic illnesses.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
1)Inhibition of Helicobacter pylori bacteria.
2)Improvement in overall GIT health.
3)Reduce frequency of medicinal intake. 		 3 months 
 
Secondary Outcome  
Outcome  TimePoints 
1.)Improvement in overall GIT health and quality of life.
2.)Therapeutic application of YGATs to prevent and moderate APDs in the other population. 		 1-1.5 years 
1)Improve Quality of life.
2)Reduce level of stress.
3)Improve work performance.
4)Prevent gastric ulcer and cancer.
 		 1 year 
 
Target Sample Size   Total Sample Size="78"
Sample Size from India="78" 
Final Enrollment numbers achieved (Total)= "34"
Final Enrollment numbers achieved (India)="34" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   01/04/2019 
Date of Study Completion (India) 31/10/2020 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="0"
Months="6"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Completed 
Publication Details
Modification(s)  		 To be published in PubMed indexed journal/s 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Brief Summary
Modification(s)  

Helicobacter pylori bacteria is the cause of most of the Gastro-Intestinal Tract infections (Mandeville et al., 2009). Fifty percent of the human population is suffering from H. pylori infection (Hooi et al., 2017) and more than 20 million Indians are estimated to suffer from the same (Thirmurthi & Graham, 2012), which has potential to cause Gastro Intestinal Diseases such as gastritis, peptic ulcer, gastric cancer, duodenal ulcer and gastric mucosal associated lymphoid-tissue such as lymphoma, anemia, vitamin B12 deficiency, gastric atrophy, primary gastric B-cell lymphoma etcetera (Malfertheener, Chan, & Coll, 2009).

In order to inhibit H. pylori, most of the patients are consuming Proton Pump Inhibitors (PPIs) such as Omeprazole, Lansoprazol, and Pantoprazole etcetera to control their symptoms related to Acid Peptic Diseases (APDs). It is common observation that a substantial number of patients keep taking PPIs for several months to years which are known to cause neuropathy, ischemic heart disease, dementia and acute kidney injury (Desbuissons, Deray & Mercadal, 2017). Over use of PPIs is not only the reason for adverse side effects but also has become a big economic burden for concerned authorities and stakeholders due to its exponentially increasing cost (Savarino, Dulbecco, Bortoli, Ottonello, & Savarino, 2016) (which is around 1355$ ) as calculated by Dache, Steward,& Graber (2007) on October 2007 and aforementioned side effects. This creates a big challenge for prevention and treatment of H. pylori in conventional medical system and warrants the need of innovative researches to discuss efficacy of complementary and Alternative Medicine (CAM) to inhibit it. In the CAM, air ingestion through YGATs, maneuvering it through the GIT and releasing it as flatus is described in the ancient yogic text (Gheranda Samhita, 1:15, 16, 17, Sarswati,1997) as a gut cleansing process.  H. pylori are micro-aerophilic organism which grows best in absence of oxygen and presence of a little carbon-dioxide (Malshe, 2016). Accordingly, various anti- H. pylori regimens are being used clinically with proven effectiveness Aeration of the gut has been proposed as an effective way to inhibit H. pylori and other microaerophilic/anaerobic microorganisms (Malshe, 2010). This warrants a Randomized Controlled Trial (RCT) entitled “Yogic Gut Aeration Techniques to Inhibit Helicobacter Pylori Induced Acid Peptic Diseases”.

To drink air, retain into pyloric region and subsequently manoeuvre it into gut to release as a flatus can be performed by two yogic ways: 1) Doing inverted postures immediately after ingesting air through kaki/bhujangi mudra to retain it into pyloric region followed its maneuvering into lower gut; and 2) Using pierced straw to drink air followed by drinking of water and then go for postural manipulation (inverted postures) as explained by Dr Malshe (2010).

Objectives

The specific objectives of the research are to assess the efficacy of YGAT on

 1) H. pylori count/infection

 2) Stress level

 3) Quality of life

 4) Frequency and doses of medication/s intake of patients afflicted with APDs.

Method

78 participants will be screened from employees and patient populations at Patanjali Yoga Peeth and other organizations using Gastrointestinal symptom rating scale, their symptoms if any would be recorded. Those who will score more than 27 will be included for the study. A short clinical examination will be made at the beginning for selected subjects that includes stool antigen test to check the presence of bacteria, to measure quality of life  the quetionnaire named â€œQuality of life for reflux and dyspepsia” will be used and for measuring stress “stress indicator questionnaire” will be used before and after the intervention. out of 78 participants 39 will be randomly allocated for each experimental and control group. experimental group will be taught the mentioned yogic techniques of drinking air. All candidates will be supervised for 3 months and their symptoms will be reviewed once again after intervention. Those who were taking PPIs regularly will be specially inquired for their need to take PPIs in-between the intervention and a special note will be made about medicinal intake. Success of the taught technique will be evaluated by questioning about gas passage, auscultation over the stomach area and plain x- ray of abdomen if needed. Control group will continue the allopathic medicine. After 3 months again stool antigen test will be taken to check the presence of bacteria for both the groups.

 
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