| CTRI Number |
CTRI/2025/03/082833 [Registered on: 19/03/2025] Trial Registered Prospectively |
| Last Modified On: |
27/09/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of neutral and cold underwater massage on bronchial asthma patient- ARCT |
|
Scientific Title of Study
|
Effect of neutral and cold underwater massage on pulmonary function test among bronchial asthma patients- 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 SHIVANGI |
| 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
250005
India |
| Phone |
8218066209 |
| Fax |
|
| Email |
shivangimogha8324@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
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
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 in Meerut, Uttar Pradesh, India-250005 |
|
|
Primary Sponsor
|
| Name |
DR SHIVANGI |
| 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
UTTAR PRADESH
250005
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 shivangi |
Maharishi Aurobindo Subharti College and Hospital of Naturopath y and Yogic Sciences |
Department of
Naturopathy and yogic sciences,
Department of Respiratory
Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
8218066209
shivangimogha8324@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| University Ethic committee (Medical) |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: J454||Moderate persistent asthma, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold Underwater Massage |
The cold underwater massage should be given to the participants for 20 mins followed by follow up for 2 hours. |
| Intervention |
Neutral Underwater Massage |
The neutral underwater massage should be given to the participants for 20 mins followed by follow up for 2 hours. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
42.00 Year(s) |
| Gender |
Both |
| Details |
willing to participate
Patients between the ages of 18 and 42 years
Both males and females are included
Based on clinical signs and symptoms
The patients who met the diagnostic criteria are included in the study
|
|
| ExclusionCriteria |
| Details |
Lung cancer
Pregnancy
Ischemic heart disease, or cardiac failure
History of alcohol/ substance abuse
Female under menstruation |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Pulmonary Function Test |
Pre and post treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Respiratory rate |
pre and post treatment |
|
|
Target Sample Size
|
Total Sample Size="150"
Sample Size from India="150"
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)
|
20/04/2025 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
20/04/2025 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
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)
|
This study hypothesis explains the impact of a neutral underwater and cold underwater massage on bronchial asthma patients using pulmonary function tests (PFT) as a parameter. Data collection of about 20% is completed |