| CTRI Number |
CTRI/2025/11/097676 [Registered on: 18/11/2025] Trial Registered Prospectively |
| Last Modified On: |
08/07/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Cool immersion bath on Overweight individuals |
|
Scientific Title of Study
|
Effect of Cool Immersion bath on Metabolic changes among Overweight Individuals - A radomised controlled trial |
| 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 Divine King J |
| Designation |
MD Scholar |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences Room Number 9 Department of Clinical Naturopathy Moodbidre Mangalore Taluk Dakshina Kannada
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
8525019305 |
| Fax |
|
| Email |
divineking9712@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Vanitha Shetty |
| Designation |
Guide |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic sciences Shobhavana Campus Mijar Moodbidri Dakshana Kannada Karnataka
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9008004542 |
| Fax |
|
| Email |
drvanithashetty16@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Prajwal H M |
| Designation |
Assistant Professor |
| Affiliation |
Alvas College of Naturopathy and Yogic Sciences |
| Address |
Alvas College of Naturopathy and Yogic Sciences, Room no 9 Tenkamijar Shobhavana Campus Moodbidri
Dakshina Kannada
KARNATAKA
574225
India |
| Phone |
9740435261 |
| Fax |
|
| Email |
hmprajwal8@gmail.com |
|
|
Source of Monetary or Material Support
|
| Alvas college of Naturopathy and Yogic sciences, Mijar,Moodbidri, Dakshana Kannada, Karnataka, India - 574225 |
|
|
Primary Sponsor
|
| Name |
Dr Divine King J |
| Address |
Alvas College of Naturopathy and Yogic Sciences, Tenkamijar, Shobavana Campus, Moodbidri |
| Type of Sponsor |
Other [Self sponser] |
|
|
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 Divine King J |
Alvas college of Naturopathy and Yogic Sciences |
Room no 3, Department of Clinical Naturopathy,Alvas college of Naturopathy and Yogic Sciences, Mijar, Moodbidri, Mangalore taluk
Dakshina Kannada
KARNATAKA |
8525019305
divineking9712@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee for human studies of ALVAS College of Naturopathy and Yogic Sciences |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E663||Overweight, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cool Immersion Bath |
Cool Immersion Bath will be given to overweight individuals for 20 minutes on alternate days for 8 weeks |
| Comparator Agent |
No intervention: will be asked to follow daily routine |
Control group is not given any interventions but they are asked to follow their daily routine for 8 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
25.00 Year(s) |
| Gender |
Both |
| Details |
1) BMI should lie between 25.0 to 29.9 kg/m2
2) Participants should be willing to engage in an 8-week intervention program |
|
| ExclusionCriteria |
| Details |
1) Subjects with any other co-morbidity
2) Subjects on any medication at the time of study
3) Doing regular workouts, exercise and yoga
4) Subjects involved in substance abuse like alcohol, tobacco, illegal drugs and other related substances
5) Subjects with mental illness |
|
|
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 |
1. BMI and anthropometric measurements
2. Fasting blood glucose level
3. Postprandial blood glucose level
4. Blood pressure |
Pre assessment - Day 0 before giving the intervention
Post assessment - After 8th week of intevntion |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Body composition (Fat free weight, Visceral fat, Subcutaneous fat, Muscle mass and Body mass) |
Pre assessment - Day 0 before giving the intervention
Post assessment - After 8th week of intevntion |
|
|
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/ Phase 3 |
|
Date of First Enrollment (India)
|
29/11/2025 |
| Date of Study Completion (India) |
29/06/2026 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This proposed study aims to investigate the effects of an
8-week cool water immersion bath intervention on metabolic changes in
overweight individuals. In a randomized controlled trial, 60 participants aged
18-25 with a BMI between 25.0 and 29.9 kg/m² will be allocated to either an
intervention group or a control group. The intervention group will undergo a
whole-body cool immersion bath (70-80°F) for 20 minutes on alternate days,
while the control group receives no intervention. Before and after the study period,
both groups will be assessed on primary outcomes including BMI, anthropometric
measurements, blood pressure, and blood glucose levels, as well as secondary
outcomes of body composition. The research hypothesizes that regular cool water
immersion will activate thermogenic processes, leading to significant
improvements in metabolic health markers compared to the control group, thereby
providing evidence for hydrotherapy as a simple, non-pharmacological approach
to managing overweight conditions. |