| CTRI Number |
CTRI/2021/07/034997 [Registered on: 20/07/2021] Trial Registered Prospectively |
| Last Modified On: |
16/07/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
EFFECT OF HOT FOOT BATH AND COLD CHEST PACK ON HYPERTENSION |
|
Scientific Title of Study
|
IMMEDIATE EFFECT OF HOT FOOT BATH AND COLD CHEST PACK ON HEART RATE VARIABILITY IN HYPERTENSIVE INDIVIDUAL - A RANDOMIZED CONTROL TRIAL |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Ajay Puri |
| 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
Swami Vivekanand Subharti University Subhartipuram, NH 58,Meerut-250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7983168847 |
| Fax |
|
| Email |
drajaykrishnapuri@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Dhiren Ajit Nair |
| 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
250005
India
Swami Vivekanand Subharti University Subhartipuram
Meerut -250005
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
250005
India
Swami Vivekanand Subharti University Subhartipuram NH-58,Meerut 250005
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| 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 |
|
|
Primary Sponsor
|
| Name |
Dr Ajay Puri |
| 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
|
| Name |
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 |
|
|
Countries of Recruitment
|
India |
|
Sites of Study
|
| No of Sites = 2 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| Dr Ajay Puri |
OPD of general medicine chattarpati shivaji subharti hospital |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti University Subhartipuram NH-58 Delhi-Haridwar Bypass Road Meerut-250005
Meerut
UTTAR PRADESH |
7983168847
drajaykrishnapuri@gmail.com |
| Dr Ajay Puri |
Out Patient Department of Naturopathy and Yoga |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences
Swami Vivekanand Subharti University Subhartipuram NH-58 Delhi-Haridwar Bypass Road Meerut-250005
Meerut
UTTAR PRADESH |
7983168847
drajaykrishnapuri@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 |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, (2) ICD-10 Condition: I10||Essential (primary) hypertension, (3) ICD-10 Condition: I10||Essential (primary) hypertension, (4) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Cold chest pack |
The application of a cold chest pack will be given for 15 minutes. subjects are made to be in sitting or supine position during the intervention. The chest pack, involved cotton material which is around 8-10 inches in width, 6-8 feet long, it should be loosely rolled up, dipped into water at 58 F - 62 F, and wrung out without unrolling. The bandage is applied in such a design. (bandage applied then again to two sections), typically two portions of a limb above and below the joint, A wool wrap of similar width and a little greater length is applied over the moist bandage firmly a similar way to make it fit gradually at each point so as exclude the air. the pack can be removed after 15 min. |
| Comparator Agent |
Hot foot bath |
The hot foot bath (HFB) comprises of setting the feet in hot water (beginning at 100 to 102.6 degrees F) and applying a cold compress to the head. It is given at temperatures going from 100 to 102.6 degrees F. This treatment can be given with the patient sitting on a seat, chair or resting. In any case, need to ensure the bedding or floor with a plastic sheet. foot tub or bucket 1â„4 loaded with water at 100-102.6 degrees F. the water temperature is gradually increased to 110 degrees F. The tub filled before subject comes for mediation or while subject is getting undressed. Pour in steaming hot water cautiously while blending in with hand, making it hotter according to patients tolerance. hot water will be added step by step until the temperature is 110 to 115 degrees F. the process will be accomplished for 15 minutes of the duration after that finish the treatment by pouring cold water over feet and dry feet completely. |
| Intervention |
Hot foot bath & Cold chest pack (both) |
The hot foot bath (HFB) comprises of setting the feet in hot water (beginning at 100 to 102.6 degrees F) and applying a cold compress to the head. It is given at temperatures going from 100 to 102.6 degrees F. This treatment can be given with the patient sitting on a seat, chair or resting. In any case, need to ensure the bedding or floor with a plastic sheet. foot tub or bucket 1â„4 loaded with water at 100-102.6 degrees F. the water temperature is gradually increased to 110 degrees F. The tub filled before subject comes for mediation or while subject is getting undressed. Pour in steaming hot water cautiously while blending in with hand, making it hotter according to patients tolerance. hot water will be added step by step until the temperature is 110 to 115 degrees F. the process will be accomplished for 15 minutes of the duration after that finish the treatment by pouring cold water over feet and dry feet completely.
The application of a cold chest pack can be given for 15 minutes. subjects are made to be in sitting or supine position during the intervention. The chest pack, involved cotton material which is around 8-10 inches in width, 6-8 feet long, it should be loosely rolled up, dipped into water at 58 F - 62 F, and wrung out without unrolling. The bandage is applied in such a design. (bandage applied then again to two sections), typically two portions of a limb above and below the joint, A wool wrap of similar width and a little greater length is applied over the moist bandage firmly a similar way to make it fit gradually at each point so as exclude the air. the pack can be removed after 15 min. |
| Comparator Agent |
Standard Treatment/ Allopathy Medication |
Medication or pharmacotherapy as prescribed based on the severity of disease & state of a being. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
59.00 Year(s) |
| Gender |
Both |
| Details |
Systolic Blood Pressure more than equal to 140mmHg and Diastolic Blood Pressure more than equal to 90mmHg |
|
| ExclusionCriteria |
| Details |
1.Secondary Hypertension
2.Cardiovascular events or hospitalisation for flimsy angina in recent 3 months
3.Pregnancy
4.A medical condition likely to restrict endurance to < 3 years or a malignancy other than non melanoma skin cancer in recent 2 years. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Heart rate variability (Blood pressure & pulse rate) |
Before & after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| N/A |
N/A |
|
|
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)
|
21/07/2021 |
| 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="2"
Months="0"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
A prospective, randomised study aims to explore the immediate effect of hot foot bath & cold chest pack individually & as combined treatment on heart rate variability in hypertensive individuals as primary outcome. |