| CTRI Number |
CTRI/2024/06/068570 [Registered on: 07/06/2024] Trial Registered Prospectively |
| Last Modified On: |
08/02/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Effect of Cold Mud Pack on Stress and Sleep in Medical Students |
|
Scientific Title of Study
|
Effect of Cold Mud Pack on Abdomen and Eyes on Acute Stress Reactivity, Perceived Stress and Sleep disturbance among Medical Students |
| 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 Nagachaithanya S |
| Designation |
PG Student |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department Of Natural Therapeutics,
SDM College of Naturopathy and Yogic Sciences, Ujire,Belthangadi,
Dakshina Kannada-574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9148983228 |
| Fax |
|
| Email |
nagachaithanya.deeksha@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nagachaithanya S |
| Designation |
PG Student |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department Of Natural Therapeutics,
SDM College of Naturopathy and Yogic Sciences, Ujire,Belthangadi,
Dakshina Kannada-574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9148983228 |
| Fax |
|
| Email |
nagachaithanya.deeksha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Geetha B Shetty |
| Designation |
Professor and Dean Division of Nutrition and Dietitics Department |
| Affiliation |
SDM College of Naturopathy and Yogic Sciences |
| Address |
Department of Nutrition and Dietetics,
SDM College of Naturopathy and Yogic Sciences, Ujire, Belthangadi,
Dakshina Kannada-574240
Karnataka
India
Dakshina Kannada
KARNATAKA
574240
India |
| Phone |
9449714767 |
| Fax |
|
| Email |
gbsujire@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sri Dharmasthala Manjunatheshwara Yoga and Nature cure hospital Shanthivana,Dharmasthala,
Belthangadi,
Dakshina Kannada-574216
Karnataka
India |
|
|
Primary Sponsor
|
| Name |
Dr Nagachaithanya S |
| Address |
SDM 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 Nagachaithanya S |
Shri Dharmasthala Manjunatheshwara Yoga and Nature cure Hospital Shanthivana |
COE, Department of Natural Therapeutics,Shanthivana,
Dharmasthala,Belthangadi,
Dakshina Kannada
Dakshina Kannada
KARNATAKA |
9148983228
nagachaithanya.deeksha@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 |
Medical Students |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Cold Mud Pack on Abdomen and Eyes |
The pasty-looking mud was spread out to a thickness of one inch in the centre of a rectangular-shaped piece of wet muslin fabric, wrapped on all sides, and kept ready in a tray, placing a mud pack over the eyes, and placing it over the pelvis just below the umbilical region of the abdomen.
duration: 5 sessions a week for 4 weeks of 20 minutes duration |
| Comparator Agent |
Dry Pack |
A cotton cloth thickness of one inch in the centre of a rectangular-shaped piece of dry muslin fabric, wrapped on all sides, and kept ready in a tray, placed over the eyes, and placing it over the pelvis just below the umbilical region of the abdomen.
Duration : 5 sessions a week for 4 weeks of 20 minutes duration |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
1. Age: 18 – 30 years
2. Subjects who are willing to participate in the study.
3. Gender: Male and Female
|
|
| ExclusionCriteria |
| Details |
1. Medical Illness
2. Subjects with open wounds
3. Had caffeine 24 hours before
|
|
|
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.Cold Pressor Test
2.Blood Pressure
3.Galvanic Skin Response |
Baseline, 4 weeks post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Perceived Stress Scale (PSS-10) |
Baseline, 4 weeks post intervention |
|
|
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)
|
01/07/2024 |
| Date of Study Completion (India) |
30/03/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/03/2025 |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
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
|
Clinically mud application in various forms is found benefited to relieve stress and reduce blood pressure in hypertensive individuals but there are no studies documented so far on the significant impact of cold mud application on abdomen and eyes. Hence this study is designed to hypothesize that there would be a significant difference in the acute stress response of the test group when the subjects have undergone cold pressor test which indicates that there was a decreased sympathetic arousal which represents cold mud pack may act on catecholaminergic activity in prefrontal cortex. 6.3.1 Objectives of the study 1. To quantify the change in acute stress response for cold pressor test after CMPEA. 2. To assess the effect of CMPEA on sleep quality and resilience among medical students. Grouping : Sixty Healthy individuals will be assessed at baseline and after 4 weeks of intervention by dividing into 2 groups with an equal number. Test group: n = 30 Control group: n = 30 |