| CTRI Number |
CTRI/2024/06/068940 [Registered on: 14/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Comparison of the immediate effects of regular and inexperienced vastra dhauti practitioners on stomach movement |
|
Scientific Title of Study
|
IMMEDIATE EFFECT OF VASTRA DHAUTI ON GASTRIC MOTILITY COMPARED BETWEEN REGULAR AND NOVICE VASTRA DHAUTI PRACTITIONERS - A QUASI EXPERIMENTAL STUDY |
| 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 Mahendra K M |
| Designation |
PG STUDENT |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
Division of research
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences
Ujire
Belthangady
Dakshina kannada
Karnataka
India 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9036869615 |
| Fax |
|
| Email |
drmahishetty29@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Ashwin V P |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
Division of research
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences
Ujire
Belthangady
Dakshina kannada
Karnataka
India 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9538372524 |
| Fax |
|
| Email |
ashwinvp09@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ashwin V P |
| Designation |
ASSISTANT PROFESSOR |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences |
| Address |
Department of Yoga
Division of research
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences
Ujire
Belthangady
Dakshina kannada
Karnataka
India 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9538372524 |
| Fax |
|
| Email |
ashwinvp09@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Nature cure Hospital Shanthivana
Dharmasthala
dakshina kannada
Karnataka
India 574240 |
|
|
Primary Sponsor
|
| Name |
DR MAHENDRA K M |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences
Ujire Belthangady Dakshina kannada 574240 |
| Type of Sponsor |
Other [Self] |
|
|
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 Mahendra K M |
Sri Dharmasthala Manjunatheshwara Nature cure Hospital |
Department of Yoga
Division of research
Dharmasthala
Dakshina Kannada
KARNATAKA |
9036869615
drmahishetty29@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Vastra dhauti |
In comparator group am taking novice vastra dhauti practitioners which includes 30 subjects
The procedure of intervention is the practitioner swallows a soft cotton cloth that is about 2 meters long and 4 centimeters wide and removes the same and it is practiced in an empty stomach
And it is practiced only one time and the duration of the intervention will 3 to 5 minutes |
| Intervention |
Vastra dhauti |
In intervention group am taking experienced vastra dhauti practitioners which includes 30 subjects
The procedure of intervention is the practitioner swallows a soft cotton cloth that is about 2 meters long and 4 centimeters wide and removes the same and it is practiced in an empty stomach
And it is practiced only one time and the duration of the intervention will 3 to 5 minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
24.00 Year(s) |
| Gender |
Both |
| Details |
Age between eighteen to twenty four years
Gender includes both Male and female
Healthy individuals
Subjects who are willing to participate |
|
| ExclusionCriteria |
| Details |
Systemic illness
Recent surgeries
Peptic ulcer |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Electrogastrogram |
3 times Electrogastrogram data will be taken
first before the intervention
second immediately after the intervention
third after 15 minutes of intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
Final Enrollment numbers achieved (Total)= "60"
Final Enrollment numbers achieved (India)="60" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
28/06/2024 |
| Date of Study Completion (India) |
22/05/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
21/05/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="7"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Completed |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
IMMEDIATE EFFECT OF VASTRA DHAUTI ON GASTRIC MOTILITY COMPARED BETWEEN REGULAR AND NOVICE VASTRA DHAUTI PRACTITIONERS -A QUASI EXPERIMENTAL STUDY The study is to understand immediate effect of vastra dhauti on electrogastrogram changes of gastric motility compared between regular and novice vastra dhauti practitioners The study subjects will be identified and screened as per the demands of the inclusion & exclusion criteria Total subjects are divided into 2 groups Group 1: 30 subjects of regular vastra dhauti practitioners Group 2: 30 subjects of novice vastra dhauti practitioners
subjects will be assessed using electrogastrogram |