| CTRI Number |
CTRI/2024/05/067137 [Registered on: 10/05/2024] Trial Registered Prospectively |
| Last Modified On: |
16/08/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Crossover Trial |
|
Public Title of Study
|
Effect of cold douche to Abdomen on gastric motility |
|
Scientific Title of Study
|
Impact of cold douche to abdomen on gastric myoelectrical activity and autonomic variables in healthy young adults |
| 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 Mithun A C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Department of Natural Therapeutics
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire,Belthangady,Dakshina kannada-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9902672179 |
| Fax |
|
| Email |
mithungowdaac7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Mithun A C |
| Designation |
PG Scholar |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Dept of Natural Therapeutics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire,Belthangady,Dakshina kannada-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9902672179 |
| Fax |
|
| Email |
mithungowdaac7@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Dean Division of Nutrition and Dietetics |
| Affiliation |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire |
| Address |
Dept of Nutrition and Dietetics, Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire,Belthangadi,Dakshina kannada-574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara yoga and Naturecure hospital Shanthivana |
|
|
Primary Sponsor
|
| Name |
Dr Mithun A C |
| Address |
Sri Dharmasthala Manjunatheshwara College of Naturopathy and Yogic Sciences,ujire,Belthangadi,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 Mithun A C |
Sri Dharmasthala Manjunatheshwara Yoga and Nature Cure Hospital Shantivana |
COE , Department of Natural Theuraputics, Shantivana, Dakshina Kannada, Karnataka
Dakshina Kannada
KARNATAKA |
9902672179
mithungowdaac7@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| SDM College of Naturopathy and Yogic Sciences Institutional Ethics Committe |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy Volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold abdominal douche |
Subjects will be obligated to remain 3.5 metres away from the douche equipment with their abdomens uncovered and facing the douche apparatus. For five minutes, the anterior abdomen surface will be subjected to a single stream of cold water(12°C–17°C)
Duration - 5minutes |
| Comparator Agent |
Neutral Abdominal Douche |
Subjects will be obligated to remain 3.5 metres away from the douche equipment with their abdomens uncovered and facing the douche apparatus. For five minutes, the anterior abdomen surface will be subjected to a single stream of neutral water (33°C–35°C)
Duration- 5minutes |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1) subjects who are willing to participate in the study after signing the informed consent form |
|
| ExclusionCriteria |
| Details |
1 Weak and debilitating individuals
2 Any medical illness/ taking medications
3 Recent surgeries
4 Smokers and alcoholics
5 Caffeine intake before 24 hours
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Gatric motility and Heart rate Variablity |
baseline, immediately after intervention, 30min after intervention and 1hr after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
•To quantify the change in dominant power and dominant frequency of gastric motility induced by cold douche to abdomen.
•To assess the percentage of change in normogastric, bradygastric and tachygastric waves.
•To corelate the change in gastric motility with change in heart rate variability
|
baseline, immediately after intervention, 30min after intervention and 1hr after intervention |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2/ Phase 3 |
|
Date of First Enrollment (India)
|
06/06/2024 |
| Date of Study Completion (India) |
12/12/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
12/12/2024 |
|
Estimated Duration of Trial
|
Years="0"
Months="6"
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
|
Douche is a hydrotherapeutic modality which uses water application with pressure to desired body parts using a single or multiple columns of water. In the therapeutic employment of the douche, active three factors are: temperature, pressure and duration . Anecdotal studies show that cold abdominal douche can be helpful in managing the altered gastric motility. It is essential to understand the underlying mechanisms before applying them as a theraputic agents. So the present study was designed to assess the influence of cold douche to abdomen on gastric myoelectrical activity. Grouping 30 healthy subjects will be assessed at 2 times with a wash out period of 2 days by dividing into 2 groups with equal number 2 Groups Group 1 (n=15) Group 2 (n=15) The institutional ethical clearance will be obtained prior to the conduct of the study. An informed consent will be obtained from the individuals by explaining the study objectives, methods, intervention after an appraisal about the study protocol. All the rights of the individual pertaining to the study will be explained to the individual in their convenient language. after selecting the elegible subjects. Allotment will be done by using a computer generated random number Day 1: Subject 1- Cold douche to abdomen(5min) Subject 2- neutral douche to abdomen Day 4: Subject 1- neutral douche to abdomen(5min) Subject 2- Cold douche to abdomen(5min) Assessments will be done before and after intervention at time intervals at T= 0,1,2,3 T= 0(baseline) T= 1(immediately after the intervention) T= 2(30minutes after intervention) T= 3(1hr after intervention)
th t |