| CTRI Number |
CTRI/2024/03/064053 [Registered on: 13/03/2024] Trial Registered Prospectively |
| Last Modified On: |
17/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A Research to see the effect of cold chest pack on PFT among Chronic obstructive pulmonary disease patient. |
|
Scientific Title of Study
|
IMPACT OF COLD CHEST PACK ON PULMONARY FUNCTION IN PATIENTS WITH COPD:- A SINGLE ARM INTERVENTION 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 Ashutosh Choudhary |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India
Meerut
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9448697044 |
| Fax |
|
| Email |
aschoudhary14@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 Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India
Meerut
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India
Meerut
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 Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India
Meerut
Department of Post Graduate Studies Subharti College and Hospital
of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut UTTAR PRADESH India
Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD of Maharishi Aurobindo Subharti College and Hospital of
Naturopathy and Yogic Science and Respiratory Department of the (CSSH) in Meerut. |
|
|
Primary Sponsor
|
| Name |
Dr Ashutosh Choudhary |
| Address |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences Swami Vivekanand Subharti University
Subhartipuram NH-58 Delhi Haridwar Bypass Road Uttar Pradesh
250005 |
| Type of Sponsor |
Other [Research PG] |
|
|
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 Ashutosh Choudhary |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Maharishi Aurobindo
Subharti College and
Hospital of Naturopathy
and Yogic Sciences
Swami Vivekanand
Subharti University
Subhartipuram NH-58
Delhi-Haridwar Bypass
Road Meerut-250005
UTTAR PRADESH
Meerut
UTTAR PRADESH |
9448697044
aschoudhary14@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) swami vivekanand subharti university |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J449||Chronic obstructive pulmonary disease, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COLD CHEST PACK |
cold chest packs are administered to research participants. Patients must stay in either a supine or sitting posture for the duration of the intervention. The cold chest pack, which is made of a cotton fabric that is 2.5 meters long and .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 to fit securely and keep out air. It will be used to cover the front and rear of the chest. After 30 minutes, the cold chest pack was removed. |
| Comparator Agent |
Not Applicable |
Not Applicable |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with COPD meet the GOLD diagnostic criteria. |
|
| ExclusionCriteria |
| Details |
Unknown source of hemoptysis [since forced expiration may make the underlying problem worse].
Pneumothorax
Unstable cardiovascular state, recent myocardial infarction, or pulmonary embolism, since forceful expiratory maneuvers might exacerbate angina or alter blood pressure.
Aneurysms in the thorax, abdomen, or brain that run the risk of rupturing due to elevated thoracic pressure.
Recent surgery of the thorax or abdomen.
Presence of acute disease process that might interfere with the test performance [e.g. nausea, vomiting]. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary function test |
Before and After Intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| pulse oximetry |
Before and After Intervention |
|
|
Target Sample Size
|
Total Sample Size="100"
Sample Size from India="100"
Final Enrollment numbers achieved (Total)= "100"
Final Enrollment numbers achieved (India)="100" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
21/03/2024 |
| Date of Study Completion (India) |
02/06/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
02/06/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| 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
Modification(s)
|
A Single-Arm Study to find the effect of a cold chest pack on pulmonary function test (PFT) and to test the hypothesis of the cold chest pack measured by the mean difference in PFT and pulse oximetry among COPD patients. 75% of the data collection has been done. |