| CTRI Number |
CTRI/2025/02/080760 [Registered on: 18/02/2025] Trial Registered Prospectively |
| Last Modified On: |
12/02/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Can cold water immersion help people with obesity to lose weight and improve their cholesterol levels |
|
Scientific Title of Study
|
Evaluating the impact of cold immersion bath on body composition and lipid profile among grade I and II obese individual
|
| 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 K Pavithra |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor),Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9361056080 |
| Fax |
|
| Email |
drpavithramd99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor),Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of Department - Naturopathy (Incharge) |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences , Chengalpattu |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor),Branch I -Department of Naturopathy, Kamarajar nagar, Chengalpattu - 603001
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu - 603001 |
|
|
Primary Sponsor
|
| Name |
Dr K Pavithra |
| Address |
International Institute of Yoga and Naturopathy Medical sciences, Chengalpattu - 603001 |
| 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 K Pavithra |
International Institute of Yoga and Naturopathy Medical sciences |
184/4 International Institute of Yoga and Naturopathy Medical Sciences Faculty block First floor Branch I Department of Naturopathy Kamarajar nagar Chengalpattu 603001
Kancheepuram
TAMIL NADU |
9361056080
drpavithramd99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E00-E89||Endocrine, nutritional and metabolic diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold immersion bath |
The subjects in the group will be given cold immersion bath for the duration of 15 to 20 minutes for 3 days per week for 6 weeks. |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
Patients with BMI ranges from 30 to 40.Patients who had the ability to tolerate cold temperature. Patients who are willing to participate in the study. |
|
| ExclusionCriteria |
| Details |
Patients with BMI ranges above 40. Patients under any medications for chronic illness. Women during menstruation, pregnancy and lactation. Patients with fever, systemic disorders like respiratory, cardiac, nervous, renal, psychiatric disorders etc. Young children and old age people. Patient who having acute infections and inflammation. Patient who are sensitive to cold temperature. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Body composition assessment, Lipid profile test |
6 Weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Anthropometric measurements |
Anthropometric measurements -Body Mass Index (BMI), waist circumference & waist-hip ratio for the patients with obesity grade I & II at baseline & after 6 weeks of intervention. |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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 |
|
Date of First Enrollment (India)
|
27/02/2025 |
| 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="1"
Months="2"
Days="2" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - YES
- What data in particular will be shared?
Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).
- What additional supporting information will be shared?
Response - Study Protocol
- Who will be able to view these files?
Response - Researchers who provide a methodologically sound proposal.
- For what types of analyses will this data be available?
Response - To achieve aims in the approved proposal.
- By what mechanism will data be made available?
Response - Proposals should be directed to [drpavithramd99@gmail.com].
- For how long will this data be available start date provided 10-12-2026 and end date provided 15-12-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Obesity is defined as
the excessive fat accumulation posing health risks, it is a global epidemic and
a major risk factor for chronic diseases like heart disease and stroke. It is a
complex, chronic disease with genetic, cultural, socioeconomic, and
environmental causes, and a leading cause of preventable death. By 2025, the
WHO estimates 167 million adults and children will be unhealthy due to
overweight or obesity. India ranks third globally in obesity, with 80 million
obese individuals and a projected rise in both urban and rural populations.
Obesity is diagnosed using Body Mass Index (BMI), calculated from height and
weight. A BMI of 25-29.9 is overweight, 30 or above is obese, with further
grades of obesity defined by higher BMI ranges. Body composition assessment,
dividing body mass into fat mass and fat-free mass, is crucial for diagnosing
and managing obesity and related nutritional problems. Obese individuals often
exhibit dyslipidemia in their lipid profile.
Naturopathy uses holistic approaches to enhance the body’s
natural healing abilities. A key principle is "Vis Medicatrix
Naturae," the healing power of nature. Naturopathic treatments include mud
therapy, hydrotherapy, magnetotherapy, massage, and other natural therapies.
Hydrotherapy, using water in various forms and temperatures is a core
component.
Cold immersion bath is one of the hydrotherapy treatment
that can be effective for obesity. Cold exposure stimulates thermogenesis,
increasing metabolic rate and potentially activating brown adipose tissue
(BAT). This activation leads to fat breakdown suggesting brown adipose tissue’s
potential in obesity treatment. While cold exposure has shown promise in
changing body measurements, lipid profiles, and body composition, the effect of
cold immersion bath specifically on these factors in obese individuals hasn’t
been studied. Therefore, this study will investigate the effects of cold
immersion baths on body composition and lipid profiles in obese individuals. |