| CTRI Number |
CTRI/2024/12/078487 [Registered on: 23/12/2024] Trial Registered Prospectively |
| Last Modified On: |
04/06/2026 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Immediate Effect of Cold Immersion Bath on Heart Rate Variability in Hypertension |
|
Scientific Title of Study
|
Immediate Effect of Cold Immersion Bath on Heart Rate Variability in Primary Hypertensive 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 |
Yumnam Thajamanbi Chanu |
| Designation |
Post graduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science |
| 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
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7500233010 |
| Fax |
|
| Email |
yumnamthajamanbi@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 Science |
| 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
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 Science |
| 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
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD and OPDN of Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Science and Medicine department of the (CSSH) in Meerut. |
|
|
Primary Sponsor
|
| Name |
Dr Yumnam Thajamanbi Chanu |
| 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 [[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 NAIR DHIREN AJIT |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram, NH 58, Delhi Haridwar Bypass road
Meerut
UTTAR PRADESH |
7899143619
danny.a.nair@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: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
COLD IMMERSION BATH |
The patients should enter the bath as soon as possible and made to lie inside the tub with the head raised and water at the neck level with a temperature of 18-24°C (64-75°F), while the head in the bath being protected by a towel wet in cold water. Vigorous rubbing by the patient himself or by one or more attendants should be applied during the entire duration of the bath. After 20 minutes, the patients should come out from the bath tub and dry himself quickly and thoroughly. |
| Comparator Agent |
SUPINE REST |
The patients have to lie down comfortably in supine position with hands and feet apart where palms facing upward for 20 minutes. |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Subjects with primary hypertension |
|
| ExclusionCriteria |
| Details |
secondary hypertension, subject with habits of regular alcohol consumption and smoking, with history or complaints of mental illness, weak and debilitating subjects, pregnant woman, female subjects during their menstrual cycle. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability |
Pre and Post intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, Pulse rate, Heart rate |
Pre & Post Intervention |
|
|
Target Sample Size
|
Total Sample Size="130"
Sample Size from India="130"
Final Enrollment numbers achieved (Total)= "130"
Final Enrollment numbers achieved (India)="130" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
01/03/2025 |
| Date of Study Completion (India) |
13/05/2026 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
13/05/2026 |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
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
Modification(s)
|
A Randomized control trial to study the immediate effect of cold immersion bath on Heart Rate Variability and to test the hypothesis of cold immersion bath and its effect on primary hypertensive individuals by measuring heart rate variability, blood pressure and pulse rate. Data collection of about 80% is completed. |