| CTRI Number |
CTRI/2025/01/079727 [Registered on: 29/01/2025] Trial Registered Prospectively |
| Last Modified On: |
27/01/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Immediate Effect of Hot and Cold Chest Pack on Spirometric Variables |
|
Scientific Title of Study
|
Immediate effect of hot and cold chest pack on spirometric variables in healthy individuals - A comparative study |
| 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 Abhinav |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Postgraduate Studies, Subharti College and Hospital
of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9720021021 |
| Fax |
|
| Email |
drabhinav0021@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Postgraduate Studies, Subharti College and Hospital
of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7899143619 |
| Fax |
|
| Email |
danny.a.nair@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abhay M Shankaregowda |
| Designation |
Principal and Dean |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Postgraduate Studies, Subharti College and Hospital
of Naturopathy and Yogic Sciences, Swami Vivekanand Subharti University, Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Dr Abhinav self financed, Swami Vivekananda Subharti University and Chhatrapati Shivaji Subharti Hospital |
|
|
Primary Sponsor
|
| Name |
Dr Abhinav |
| Address |
Department of Post Graduate Studies Maharishi Aurobindo Subharti
College and Hospital of Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University Subhartipuram, NH 58,Haridwar
Bypass Road meerut Uttar Pradesh 250005 |
| 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 Abhinav |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science |
Swami Vivekanand
Subharti University
Subhartipuram NH-58
Delhi-Haridwar Bypass
Road
Meerut
UTTAR PRADESH |
9720021021
drabhinav0021@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee Medical |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
healthy individuals |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold Chest Pack |
Patients are required to stay in either a supine or sitting posture for the length of the intervention. The cold chest pack, which is made of a cotton fabric that is 2.5 meters long and 0.5 meters broad, should be loosely wrapped up, soaked in water that is between 58°F - 62°F, and then wrung out without unrolling. The wet bandage must be applied in the same way at every site in order to fit securely and keep out air. It will be used to cover the front and rear of the chest. Over a wet bandage, a woolen wrap of comparable breadth and a little wider width is placed firmly and carefully at each point to keep out air. After 20 minutes, the cold chest pack was removed |
| Intervention |
Hot Chest Pack |
This chest pack is unique in its design and function. A cotton cloth measuring roughly 2.5 m in length and 0.5 m in width was immersed in water and properly wrung out. After that, it was wrapped over the chest, covering the front and back, and then wrapped with the same-sized woollen wrap. This was done for 20 minutes The water temperature should be maintained from 97 fahrenheit to 104 fahrenheit |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Age 18-30 years
Both genders will be involved
Subjects who are willing to participate in the study |
|
| ExclusionCriteria |
| Details |
Open wound or scar on chest or back
The occurrence of an acute illness that could affect test performance (such as vomiting or nausea).
Recent surgery of the thorax or abdomen
Female under menstruation
Pregnant and lactating women
Volunteers with diagnosed medical conditions
Any other co-morbid conditions are excluded. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test |
The assessment will be taken immediately before and after intervention
|
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.Blood pressure
2.Pulse rate
3.SpO2
4.Breath Holding Time
5.Respiratory Rate |
Before & after the intervention |
|
|
Target Sample Size
|
Total Sample Size="120"
Sample Size from India="120"
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
|
N/A |
|
Date of First Enrollment (India)
|
07/03/2025 |
| 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="0"
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
|
A COMPARATIVE STUDY: IMMEDIATE EFFECT OF HOT AND COLD CHEST PACK ON SPIROMETRIC VARIABLES IN HEALTHY INDIVIDUALS Various research studies on hydrotherapy measures show effective results in multiple parameters among healthy people. However, the impact of hot and cold chest packs on PFT has not been examined till now. Thus, the current study is designed to assess the effects of hot and cold chest packs on pulmonary function tests among healthy individuals. |