| CTRI Number |
CTRI/2026/01/100288 [Registered on: 05/01/2026] Trial Registered Prospectively |
| Last Modified On: |
04/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Other |
|
Public Title of Study
|
Immediate effect of hot foot bath with Epsom salt on blood pressure in prehypertensive patients |
|
Scientific Title of Study
|
Immediate effect of hot foot bath with Epsom salt on blood pressure among prehypertensive patients—A pilot 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 Preety Kumari Jaiswal |
| Designation |
undergraduate student |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Maharishi Aurobindo Subharti College and Hospital of
Naturopathy and Yogic Sciences Swami
Vivekanand Subharti University, Subhartipuram Meerut,
UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
8923288365 |
| Fax |
|
| Email |
preetyjais18@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR NAIR DHIREN AJIT |
| Designation |
Associate Professor and Post Graduate (PG) coordinator |
| Affiliation |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
| Address |
Department of undergraduate Maharishi Aurobindo Subharti College and Hospital of
Naturopathy and Yogic Sciences Swami Vivekanand Subharti University, Subhartipuram, Meerut, UTTAR PRADESH, India
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 undergraduate Maharishi Aurobindo Subharti College and Hospital of
Naturopathy and Yogic Sciences Swami Vivekanand Subharti University, Subhartipuram, Meerut, UTTAR PRADESH, India
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD/OPD of Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Science in Meerut, Uttar Pradesh, India-250005 |
|
|
Primary Sponsor
|
| Name |
Dr. Preety kumari jaiswal |
| 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 Preety kumari jaiswal |
Subharti yoga and naturopathy Hospital |
Department of
Naturopathy and yogic
sciences, Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH |
8923288365
preetyjais18@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 2 |
| Name of Committee |
Approval Status |
| University Ethics Committee (Medical) swami vivekanand subharti university |
Approved |
| 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 |
Hot foot bath with epsom salt |
The pre-analysis of patients is done before starting the procedure, then epsom salt is added to a tub full of hot water. The patient is asked to immerse the foot inside the tub and a cold compress is kept on the head. The temperature of the water is maintained at 38-40 degrees celsius throughout the procedure. The treatment is carried out for 15 to 20 minutes. After the treatment the foot is wiped with the turkish towel. Later on post-analysis of the patient is done and assessed. |
| Comparator Agent |
Hot foot immersion |
The pre-analysis of patients is done before starting the procedure, then a tub full of hot water. The patient is asked to immerse the foot inside the tub and a cold compress is kept on the head. The temperature of the water is maintained at 38 to 40 degrees celsius throughout the procedure. The treatment is carried out for 15 to 20 minutes. After the treatment the foot is wiped with the turkish towel. Later on post-analysis of the patient is done and assessed. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
35.00 Year(s) |
| Gender |
Both |
| Details |
Subjects who are readily active to be part of the study.
Independent individual.
No secondary hypertension.
|
|
| ExclusionCriteria |
| Details |
Patient with secondary hypertension
Patient those who are not willing to participate in the study
Pregnancy
Patient having blood pressure above 140 mm hg |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRV |
Baseline and post-intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure, Pulse rate, Spo2 |
Baseline & post-intervention |
|
|
Target Sample Size
|
Total Sample Size="24"
Sample Size from India="24"
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)
|
16/01/2026 |
| Date of Study Completion (India) |
Applicable only for Completed/Terminated trials |
| Date of First Enrollment (Global) |
16/01/2026 |
| Date of Study Completion (Global) |
Applicable only for Completed/Terminated trials |
|
Estimated Duration of Trial
|
Years="0"
Months="5"
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
|
In this study an intervention group receives a hot foot bath (39°C and 43°C) with Epsom salt for prehypertensive individuals for 15-20 minutes. Heart rate variability, blood pressure, pulse rate, and SpO2 analysis are done before and after the intervention. Similarly, the control group will receive only a hot foot bath of 39°C-43°C, and heart rate variability, Blood pressure, Pulse rate, and spo2 analysis is done before and after the intervention |