| CTRI Number |
CTRI/2025/03/082425 [Registered on: 17/03/2025] Trial Registered Prospectively |
| Last Modified On: |
14/03/2025 |
| 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
|
Does Hot and Cold Wet Cloth affect Breathing and Heart Rate. |
|
Scientific Title of Study
|
To Evaluate the Immediate Effect of Hot and Cold Lung Compress on Cardiopulmonary Parameters in Healthy Individuals: A Randomized 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 Minu Rajalakshmi R L |
| Designation |
Post graduate scholar |
| Affiliation |
Internatioanal Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, Internatioanal Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
6381877182 |
| Fax |
|
| Email |
minurajalakshmi.23@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr M Pandiaraja |
| Designation |
Head of the Department - Naturopathy (Incharge) |
| Affiliation |
Internatioanal Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, Internatioanal Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu.
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 the Department - Naturopathy (Incharge) |
| Affiliation |
Internatioanal Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4, Internatioanal Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU
603001
India |
| Phone |
9952448729 |
| Fax |
|
| Email |
drpandiarajamuthupandimd@gmail.com |
|
|
Source of Monetary or Material Support
|
| 184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First Floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu-603001, Tamilnadu, India. |
|
|
Primary Sponsor
|
| Name |
Dr Minu Rajalakshmi R L |
| Address |
184/4, International Institute of Yoga and Naturopathy Medical Sciences, Faculty block(First Floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu-603001, Tamilnadu, India. |
| 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 Minu Rajalakshmi R L |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4, Internatioanal Institute of Yoga and Naturopathy Medical Sciences, Faculty block (First floor), Department of Naturopathy, Kamarajar Nagar, Chengalpattu.
Kancheepuram
TAMIL NADU |
06381877182
minurajalakshmi.23@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical College and Sciences, Chengalpattu, Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Healthy individuals
|
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Application of hot and cold lung compress |
Subjects will be given hot and cold lung compress for 20 minutes, where a hot fomentation bag will be applied over the dorsal region reaching from the base of the neck to the level of the thoracic vertebrae 12 region, while the cold compress will cover the ventral side from the base of the neck, the whole anterior surface of the chest to the level of the lowest rib. The water temperature will be maintained for hot compress at (98-104 degree F) and for cold compress at (55-65 degree F) |
| Comparator Agent |
Lying in a resting position |
Controls will be lying down in supine position with a cotton cloth wrapped around their thorax. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
40.00 Year(s) |
| Gender |
Both |
| Details |
Individuals who are healthy, does not currently or previously have a history of cardiac and/or respiratory systemic disorders of both genders. Individuals who are willing to give consent. |
|
| ExclusionCriteria |
| Details |
Individuals who currently have and/or previously had a history of cardiac, respiratory systemic illness due to primary or secondary causes. Individuals with a previous history of thoracic and abdominal surgery. Individuals with a habit of chewing tobacco and smoking. Individuals who practice regular active and aquatic sports. Individuals who are pregnant, lactating and menstruating women. Individuals who are not willing to participate in the study. |
|
|
Method of Generating Random Sequence
|
Adaptive randomization, such as minimization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV1). |
The values of Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV1) will be measured before and after the intervention. (Pre- and post-study). |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Assessment of Heart Rate Variability (HRV) |
values of Heart Rate Variability (HRV) before, during, & after the intervention. |
|
|
Target Sample Size
|
Total Sample Size="90"
Sample Size from India="90"
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)
|
13/04/2025 |
| 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) |
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 - YES
- What data in particular will be shared?
Response - All of the individual participant data collected during the trial, after de-identification.
- What additional supporting information will be shared?
Response - Study Protocol
Response - Informed Consent Form
- 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 [minurajalakshmi.23@gmail.com].
- For how long will this data be available start date provided 13-04-2025 and end date provided 17-11-2026?
Response - Immediately following publication. No end date.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - NIL
|
|
Brief Summary
|
Cardiorespiratory fitness (CRF) is a key indicator of overall health, reflecting the body’s ability to transport oxygen and nutrients to cells. CRF is linked to cardiovascular and respiratory health, and research shows that it is a reliable predictor of cardiovascular disease and mortality. In fact, studies suggest that CRF is a more reliable indicator of cardiovascular health than traditional risk factors like hypertension, diabetes, and obesity.
Pulmonary function tests (PFTs), such as Peak Expiratory Flow Rate (PEFR) and Forced Expiratory Volume (FEV), provide valuable insights into lung function. Heart rate and heart rate variability (HRV) are also important indicators of cardiovascular health. HRV, in particular, is emerging as a tool for diagnosing cardiac diseases. Naturopathic treatments, including hydrotherapy, aim to restore health by promoting healthy lifestyle habits and using natural remedies.
The application of hot and cold compresses, specifically lung compresses, may have a positive impact on heart rate variability, pulmonary function tests, and overall cardiopulmonary fitness. Research suggests that cold compresses can reduce heart rate and blood pressure, while hot compresses can improve pulmonary function. The use of lung compresses may be a useful adjunctive therapy for improving cardiovascular and respiratory health. |