| CTRI Number |
CTRI/2025/02/080378 [Registered on: 12/02/2025] Trial Registered Prospectively |
| Last Modified On: |
11/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Effect of Yogic Cleansing Technique (Vaman Dhauti) on Heart Rate Variability in Healthy University Students |
|
Scientific Title of Study
|
Trigeminal mechanical stimulation of the dorsal anterior mucosal surface of the tongue by Vaman Dhauti: Effects on Heart Rate Variability (HRV) |
| 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, Neurophysiology lab, Lab no.- 5, Central university of Rajasthan, Ajmer, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
8618142265 |
| Fax |
|
| Email |
sanjib.patra@curaj.ac.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Megha Pundir |
| Designation |
PhD Scholar |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Neurophysiology lab, Lab no.- 5, Central university of Rajasthan, Ajmer, Rajasthan, India
Ajmer
RAJASTHAN
305817
India |
| Phone |
8218172780 |
| Fax |
|
| Email |
meghapundeer20899@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Megha Pundir |
| Designation |
PhD Scholar |
| Affiliation |
Central University of Rajasthan |
| Address |
Department of Yoga, Neurophysiology lab, Lab no.- 5, Central university of Rajasthan, Ajmer, Rajasthan, India
RAJASTHAN
305817
India |
| Phone |
8218172780 |
| Fax |
|
| Email |
meghapundeer20899@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central University of Rajasthan, Ajmer, Rajasthan, Pin- 305817, India |
|
|
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 University of Rajasthan, a 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 |
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 |
| Healthy Human Volunteers |
Healthy University students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Vaman Dhauti (Voluntarily induced vomiting) |
Vaman Dhauti is a yogic cleansing technique that involves voluntarily inducing regurgitation to expel stomach impurities, promoting digestive health and detoxification. Participants will perform Vaman Dhauti only once. This is an immediate effect study so intervention will be given only once. |
| Comparator Agent |
Vomit mimicary after drinking normal water |
Participants will drink normal water and mimic vomiting without touching any part of tongue only once. This is an immediate effect study so intervention will be given only once. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
28.00 Year(s) |
| Gender |
Both |
| Details |
Healthy university students aged 18–30 years.
Willing to provide written informed consent and comply with study procedures.
Normal resting heart rate and blood pressure within the healthy range. |
|
| ExclusionCriteria |
| Details |
History of cardiovascular, neurological, respiratory, gastrointestinal, or metabolic disorders.
Any psychiatric illness, substance abuse, or use of medications affecting autonomic function.
History of gastric ulcers, acid reflux, or any other digestive issues.
Recent or chronic upper respiratory tract infections.
Pregnant or lactating women. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
ECG: Test will be used to assess Heart rate variability.
Photoplethysmography (PPG) will be used to detect volumetric changes in blood in peripheral circulation.
|
We will conduct four assessments on two separate days: (1) Vaman Dhauti Condition: Baseline assessment before performing Vaman Dhauti and post-intervention assessment immediately after. (2) Control Condition (Drinking Normal Water): Baseline assessment before drinking normal water and post-intervention assessment immediately after. These time points will help compare the effects of Vaman Dhauti with the control condition. |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Photoplethysmography (PPG) will be used to detect volumetric changes in blood in peripheral circulation. |
We will conduct four assessments on two separate days: (1) Vaman Dhauti Condition: Baseline assessment before performing Vaman Dhauti & post-intervention assessment immediately after. (2) Control Condition (Drinking Normal Water): Baseline assessment before drinking normal water & post-intervention assessment immediately after. These time points will help compare the effects of Vaman Dhauti with the control condition. |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
25/02/2025 |
| 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="2"
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
|
The purpose of this scientific study is to understand
the effect of mechanically stimulation of the dorsal anterior mucosal surface
of the tongue by Vaman Dhauti on cardiac activity by HRV and BVP (Blood Volume
Pulse) obtained from ECG recording using BIOPAC MP36R four-channel amplifier
Systems. |