| CTRI Number |
CTRI/2024/04/065675 [Registered on: 15/04/2024] Trial Registered Prospectively |
| Last Modified On: |
30/07/2025 |
| 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 wet sheet pack on autonomic variables among healthy participants |
|
Scientific Title of Study
|
“Effect Of Full Cold Wet Sheet Pack On Heart Rate Variability Among Healthy Individuals- A Single Arm Pre-Post 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 Rakhee Sharma |
| Designation |
Post Graduate student |
| Affiliation |
Maharishi Aurbindo 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
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut
UTTAR PRADESH
Meerut
UTTAR PRADESH
250005
India |
| Phone |
7535955846 |
| Fax |
|
| Email |
rakheesharma5846@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Nair Dhiren Ajit |
| Designation |
Assistant Professor and Post graduate (PG) coordinator |
| Affiliation |
Maharishi Aurbindo 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
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram 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 Aurbindo 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
Department of Post Graduate Studies Subharti College and Hospital of Naturopathy and Yogic Sciences Swami Vivekanand Subharti
University Subhartipuram Meerut
Meerut
UTTAR PRADESH
250005
India |
| Phone |
9639010531 |
| Fax |
|
| Email |
naturopathy@subharti.org |
|
|
Source of Monetary or Material Support
|
| Naturopathy and Yoga IPD and College of Maharishi Aurobindo Subharti College and Hospital of Naturopathy
and Yogic Sciences |
|
|
Primary Sponsor
|
| Name |
Dr Rakhee Sharma |
| 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 [] |
|
|
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 Rakhee Sharma |
Maharishi Aurobindo Subharti College and Hospital of Naturopathy and Yogic Sciences |
Swami Vivekanand
Subharti University
Subhartipuram NH-58
Delhi-Haridwar Bypass
Road
Meerut
UTTAR PRADESH |
7535955846
rakheesharma5846@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 |
| Healthy Human Volunteers |
Healthy |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
full cold wet sheet pack |
The participant will be positioned such that the upper border of the linen cloth (wet sheet) is only a few centimetres past their shoulders. participant extends both arms over head while the attendant bring one side of the wet sheet across the body, turning it well up under the arms and tucking it in comfortably all along the side of the body. The sheets edge is tucked over the leg of the matching side from the hips down, leaving the other leg exposed. As the individual lowers his arm and keeps them close by their side, the other half of the sheet is moved over, tucked up at the side, and wrapped over the exposed leg. The body is enveloped so firmly under the cool, moist sheet. After that, a cold compress will be applied to each participants head. Dry woollen blankets completely ringed the building outside of this. After that, the dry sheet at the head is folded neatly over each shoulder and tucked under the shoulder. Next, the woollen cloth is tucked under at the foot. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
30.00 Year(s) |
| Gender |
Both |
| Details |
Both genders
Age between 18 – 30 years
Subjects who are willing to participate in the study after signing the informed consent form
|
|
| ExclusionCriteria |
| Details |
Volunteers with diagnosed medical conditions
Subject with open wounds
Recent surgeries
Weak and debilitating persons
Inflammatory skin conditions
Cardiovascular co-morbidities
Pregnant and lactating women
Female under menstruation |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| HRV (Heart Rate Variability) Frequency domain (LF HF LF/HF) and Time domain(R-R RMSSD NN50 PNN500) |
The evaluations will be taken five minutes before the intervention followed by a post-assessment five minutes later with assessments taking place every 30 minutes for the next one hour |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Blood pressure (SBP DBP) Pulse rate Heart rate |
The evaluations will be taken five minutes before the intervention followed by a post-assessment five minutes later with assessments taking place every 30 minutes for the next one hour |
|
|
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
|
Phase 1 |
|
Date of First Enrollment (India)
|
20/04/2024 |
| Date of Study Completion (India) |
30/07/2025 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
30/07/2025 |
|
Estimated Duration of Trial
|
Years="1"
Months="0"
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 Research To Evaluate The Effect Of Cold Wet Sheet Pack Upon Autonomic Variables Like Heart Rate Blood Pressure Pulse Rate Among Healthy Volunteers So That The Knowledge Gained From This Can Be Directly Apply To Clinical Aspects. |