| CTRI Number |
CTRI/2025/11/096840 [Registered on: 03/11/2025] Trial Registered Prospectively |
| Last Modified On: |
30/10/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
effect of Revulsive compress in patients with abnormal cholestrol levels |
|
Scientific Title of Study
|
Effect of revulsive compress to liver region on lipid profile in patients with dyslipidaemia: A single group 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 R Sangamithraa |
| Designation |
PG scholar |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of naturopathy,Government Yoga and Naturopathy medical college and hospital,PG block,Arumbakkam,Chennai
Department of Naturopathy, Government Yoga and Naturopathy medical college and hospital,PG block,Arumbakkam,Chennai-6000106
Chennai
TAMIL NADU
600106
India |
| Phone |
8825568738 |
| Fax |
|
| Email |
sangamithraa135@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A Mooventhan |
| Designation |
Assistant medical officer cum lecturer grade 2 |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of research,Second floor,Government Yoga and Naturopathy medical college and hospital,PG block,Arumbakkam,Chennai
Department of research,Second floor,Government Yoga and Naturopathy medical college and hospital,PG block,Arumbakkam,Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9844457496 |
| Fax |
|
| Email |
dr.mooventhan@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Sangamithraa |
| Designation |
PG scholar |
| Affiliation |
Government yoga and naturopathy medical college and hospital |
| Address |
Department of naturopathy,Government Yoga and Naturopathy medical college and hospital,PG block,Arumbakkam,Chennai
Department of Naturopathy, Government Yoga and Naturopathy medical college and hospital,PG block,Arumbakkam,Chennai-6000106
Chennai
TAMIL NADU
600106
India |
| Phone |
8825568738 |
| Fax |
|
| Email |
sangamithraa135@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Government Yoga and Naturopathy Medical College and Hospital |
| Address |
Government Yoga and Naturopathy Medical College and Hospital,Arumbakkam,Chennai |
| Type of Sponsor |
Government medical college |
|
|
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 |
| A Mooventhan |
Government Yoga and Naturopathy medical college and hospital |
Government Yoga and Naturopathy medical college and hospital,
Arumpakkam,
chennai - 600106
Chennai
TAMIL NADU |
09943797853
dr.mooventhan@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Government Yoga and Naturopathy Medical College Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Healthy Human Volunteers |
Dyslipidaemia (ICD-10 Code: E78.5 – Disorder of lipoprotein metabolism, unspecified) |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NL |
NIL |
| Intervention |
Revulsive compress to liver region |
Subjects will be given a revulsive compress [alternating hot (98–104°F / 36–40°C) fomentation bag for four minutes, followed by cold (55–65°F / 12–18°C) ice bag for one minute] to the liver region (right hypochondrium and lumbar, and epigastric). This sequence constitutes one cycle. Each session will be repeated for a total of four cycles, resulting in an overall treatment duration of 20 minutes. Each session will always begin with hot and end with cold. The therapy will be administered five days per week over two consecutive weeks. Temperatures will be monitored using a digital water thermometer to ensure consistency. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
45.00 Year(s) |
| Gender |
Both |
| Details |
The study targets adult men and women aged between 18 and 45 years who have dyslipidaemia as per NCEP criteria and are willing to undertake the procedure by signing the written consent form |
|
| ExclusionCriteria |
| Details |
Subjects with comorbidities such as uncontrolled diabetes and hypertension, chronic kidney disease, and cardiovascular disease.
Subjects with a history of hypersensitivity to cold or hot applications
Skin conditions or infections over the abdominal or liver region
Pregnant or lactating women, and menstruating women
Participating in any other clinical trial in the past 3 months
Alcohol or substance abuse
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Lipid profile |
Lipid profile will be taken before and after the intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="37"
Sample Size from India="37"
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)
|
10/11/2025 |
| 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="1"
Months="6"
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
|
This single-group pre-post interventional study aims to evaluate the effect of revulsive compress therapy applied to the liver region on the lipid profile of adults with dyslipidaemia. Dyslipidaemia is a major risk factor for cardiovascular diseases, often requiring long-term pharmacological therapy that may cause adverse effects. As an alternative, naturopathic hydrotherapy methods such as revulsive compress—an alternating hot and cold water application—may enhance hepatic circulation, stimulate metabolism, and support lipid regulation. A total of 37 adults (aged 18–45 years) clinically diagnosed with dyslipidaemia (as per NCEP guidelines) will be recruited from the Government Yoga and Naturopathy Medical College & Hospital, Arumbakkam, Chennai. Participants will receive revulsive compress therapy to the liver region (right hypochondrium, lumbar, and epigastric areas) for 20 minutes per session, five days per week, for two consecutive weeks. Each session involves alternating hot (36–40°C for 4 minutes) and cold (12–18°C for 1 minute) applications, repeated in four cycles, starting and ending with heat. Lipid profile parameters:Total Cholesterol (TC), Triglycerides (TG), High-Density Lipoprotein (HDL-C), and Low-Density Lipoprotein (LDL-C) will be measured before and after the intervention. Data will be analyzed using appropriate statistical methods to determine changes in lipid levels. This study seeks to provide scientific evidence for the potential of hydrotherapy-based naturopathic interventions as a safe and effective adjunct for improving lipid metabolism in patients with dyslipidaemia. |