| CTRI Number |
CTRI/2025/07/090020 [Registered on: 02/07/2025] Trial Registered Prospectively |
| Last Modified On: |
18/04/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Studying the effect of an 8-week yoga, diet, and counseling program on improving gut health in people with asthma. |
|
Scientific Title of Study
|
Efficacy of a eight week life style modification
programme (yoga, diet and counselling) on Gut
microbial diversity in Asthmatics |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Sanjib Patra |
| Designation |
Professor |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Roll no.- 05, Central University of Rajasthan, pin- 305817, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
08218172780 |
| Fax |
|
| Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Sanjib Patra |
| Designation |
Professor |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Roll no.- 05, Central University of Rajasthan, pin- 305817, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
08218172780 |
| Fax |
|
| Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person
Public Query
|
| Name |
Sanjib Patra |
| Designation |
Professor |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Roll no.- 05, Central University of Rajasthan, pin- 305817, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
08218172780 |
| Fax |
|
| Email |
sanjib.patra@curaj.ac.in |
|
|
Source of Monetary or Material Support
|
| Central university of Rajasthan |
|
|
Primary Sponsor
|
| Name |
Central University of Rajasthan |
| Address |
Department of Yoga, Neurophysiology lab, Lab no- 5, Central University of Rajasthan, Ajmer, Rajasthan,
Pin- 305817, India |
| Type of Sponsor |
Other [Central government 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 Sanjib Patra |
Central University of Rajasthan |
Department of Yoga, Neurophysiology
lab, lab no.- 5
Ajmer
RAJASTHAN
Ajmer
RAJASTHAN |
8618142265
sanjib.patra@curaj.ac.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Human Institutional Ethics committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J668||Airway disease due to other specific organic dusts, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Control group will be continue with their conventional care. |
Control group will be continue with their conventional care and no other intervention will be given to this group. |
| Intervention |
Yoga based lifestyle program including counselling and diet modification |
8 weeks intervention of yoga classes, diet modification, personal counselling, massage therapy. Intervention will be given 5 hours daily for 8 weeks. |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Both male and female aged between 35 and 70.
Participants diagnosed with allergic Asthma.
Participants with no prior exposure to Yoga. |
|
| ExclusionCriteria |
| Details |
a)Participants have other respiratory complications such as Emphysema, Tuberculosis, Pulmonary fibrosis, etc. Hypertension, and Tuberculosis.
b)Participants consume drugs and steroids
c)Participants have severe Neurological and Psychiatric disorders.
d)Participants with severe Insomnia and other co-morbidity.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
Percentage of beneficial gut microbiota (probiotics) as measured by shotgun metagenome sequencing.
Presence or absence of pathogenic bacteria and fungi in the intestinal microbiome. |
These will be assessed at baseline (Week 0) and post-intervention (Week 8). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Antibiotic resistance against common antibiotics
Metabolites such as vitamins, Neurotransmitters, & SCFAS (Short chain fatty acids) before & after the interventions based on the algorithm-based output. |
These will be assessed at baseline (Week 0) & post-intervention (Week 8). |
|
|
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
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
15/07/2025 |
| 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="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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
|
The goal of the study is to assess the diversity of gut microbiota and the metabolites produced by the bacteria in asthmatics. To measure the population of beneficial bacteria and the presence or absence of pathogenic microorganisms. |