| CTRI Number |
CTRI/2026/02/104524 [Registered on: 23/02/2026] Trial Registered Prospectively |
| Last Modified On: |
19/02/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of cold water immersion bath with Epsom salt (magnesium sulphate) in young adults |
|
Scientific Title of Study
|
Endocrine and autonomic response to cold water immersion bath with epsom salt in young adults: A randomized 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 Sujatha K J |
| Designation |
Professor and Dean |
| Affiliation |
Sri Dharmastala Manjunatheshwara college of Naturopathy and yogic sciences , Ujire |
| Address |
Devamoole house,Ramakrishna Nagar,Kandrady,Ujire,Karnataka-574240
Sri Dharmastala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire, Belthangady, Dakshina Kannada, Karnataka 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Sujatha K J |
| Designation |
Professor and Dean |
| Affiliation |
Sri Dharmastala Manjunatheshwara college of Naturopathy and yogic sciences , Ujire |
| Address |
Devamoole house,Ramakrishna Nagar,Kandrady,Ujire,Karnataka-574240
Sri Dharmastala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire, Belthangady, Dakshina Kannada, Karnataka 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sujatha K J |
| Designation |
Professor and Dean |
| Affiliation |
Sri Dharmastala Manjunatheshwara college of Naturopathy and yogic sciences , Ujire |
| Address |
Devamoole house,Ramakrishna Nagar,Kandrady,Ujire,Karnataka-574240
Sri Dharmastala Manjunatheshwara College of Naturopathy and Yogic Sciences,Ujire, Belthangady, Dakshina Kannada, Karnataka 574240
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9480401646 |
| Fax |
|
| Email |
drsujathadinesh2@gmail.com |
|
|
Source of Monetary or Material Support
|
| Rajiv Gandhi University of Health Sciences.
4th T block, Jayanagar, Bengaluru- 560041 |
| Sri Dharmastala Manjunatheshwara yoga and nature cure hospital, Shantivana, Dharmasthala 574216 |
| Sri Dharmastala Manjunatheshwara College of Naturopathy and Yogic Ssciences,Ujire Belthangady taluk, Dakshina Kannada District- 574240 |
|
|
Primary Sponsor
|
| Name |
Rajiv Gandhi University of Health Sciences . |
| Address |
4th T Block, Jayanagar, Bangalore -500041 |
| Type of Sponsor |
Government funding agency |
|
|
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 Sujatha K J |
Sri Dharmastala Manjunatheshwara yoga and Nature cure hospital, Shantivana |
COE Department of Natural therapeutics, Shantivana , Dharmastala, Belthangady taluk, Dakshina Kannada, Karnataka District, Karnataka -574216
Dakshina Kannada
KARNATAKA |
9480401646
drsujathadinesh2@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Sri Dharmastala 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 human volunteers |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold immersion bath |
Fill the tub with cold water at 25 degrees Celsius. Ask the subject to enter the tub with minimal clothing. Immerse the entire body for 20 minutes in head out position. |
| Intervention |
Cold immersion bath with epsom salt |
Fill the tub with cold water at 25 degrees Celsius. Add 200gms of epsom salt. Ask the subject to enter the tub with minimal clothing. Immerse the entire body for 20 minutes in head out position. |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
38.00 Year(s) |
| Gender |
Both |
| Details |
1. Healthy young adult volunteers
2. Subjects willing to participate by giving written consent. |
|
| ExclusionCriteria |
| Details |
1. History of mental illnesses
2. Subject with a history of alcohol and substance abuse
3. Female subjects during menstruation
4. Subjects under any medications during the study
5. Subjects with any disability and open wounds. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Testosterone
2. Cortisol
3. Dehydroepiandrosterone sulfate (DHEA-S)
4. Prolactin
5. Heart rate variability |
T1-baseline
T2- Immediately after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
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)
|
09/03/2026 |
| 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="4"
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
|
Cold water immersion (CWI) has become popular in sports as it is a low-cost technique that is easily performed in different situations and has been found to alleviate physiological and functional deficits associated with exercise-induced muscle damage. Despite its widespread use, significant procedural variations in Cold Water Immersion exist. Studies claim that the magnitude of these mechanisms depends on the intensity of the cold and how it affects the body. Using mineral water, peloids, or gases for illness prevention, treatment, or health promotion is known as Balneotherapy. Epsom salt has numerous applications, from establishing at-home spas to relieving sore muscles and lowering discomfort. Magnesium sulfate, a mineral found in Epsom salt, reduces pain. Magnesium functions as a cofactor in numerous metalloenzymes mechanistically. Magnesium is a calcium antagonist necessary for the proper functioning of the heart, muscles, and nerves. When Epsom salt is introduced to water, the Epsom salt separates into magnesium ions and sulfate ions, which are both readily absorbed by the skin. Magnesium reduces stress by diminishing the effects of adrenaline and encouraging the release of serotonin, which makes one feel calm. Because of its analgesic and anti-inflammatory qualities, it is a complementary alternative to steroidal and hormonal therapy. This study aims to evaluate the effect of cold-water immersion with Epsom salt on endocrine hormones on autonomic variables among healthy volunteers. |