| CTRI Number |
CTRI/2025/07/090445 [Registered on: 08/07/2025] Trial Registered Prospectively |
| Last Modified On: |
07/07/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Yoga & Naturopathy |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Banana Leaf bath for obesity |
|
Scientific Title of Study
|
Effect of Plantain Leaf Bath on Body Stat among Obesity: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 |
Preethi VC |
| Designation |
UG Student |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty Block(first floor),Department of Yoga,Kamarajar Nagar,Chengalpattu.
Kancheepuram
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8667802398 |
| Fax |
|
| Email |
preethivc43@gmail.com |
|
Details of Contact Person Scientific Query
|
| Name |
Dr M P Ramesh |
| Designation |
PG Scholar |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty Block(first floor),Department of Yoga,Kamarajar Nagar,Chengalpattu.
Kancheepuram
Kancheepuram TAMIL NADU 603001 India |
| Phone |
9787899899 |
| Fax |
|
| Email |
dr.rameshbnys@gmail.com |
|
Details of Contact Person Public Query
|
| Name |
Preethi VC |
| Designation |
UG Student |
| Affiliation |
International Institute of Yoga and Naturopathy Medical Sciences |
| Address |
184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty Block(first floor),Department of Yoga,Kamarajar Nagar,Chengalpattu.
Kancheepuram
Kancheepuram TAMIL NADU 603001 India |
| Phone |
8667802398 |
| Fax |
|
| Email |
preethivc43@gmail.com |
|
|
Source of Monetary or Material Support
|
| 184/4, International Institute of Yoga and Naturopathy Medical Sciences, Chengalpattu, Tamil Nadu, Pin-603001 |
|
|
Primary Sponsor
|
| Name |
Directorate of Indian Medicine and Homeopathy |
| Address |
Arumbakkam,Near Anna Arch,Chennai-600106 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 Ramesh |
International Institute of Yoga and Naturopathy Medical Sciences |
184/4,International Institute of Yoga and Naturopathy Medical Sciences,Faculty Block(first floor), Room No: 01,Department of Yoga,Kamarajar Nagar. Kancheepuram TAMIL NADU |
9787899899
dr.rameshbnys@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| International Institute of Yoga and Naturopathy Medical Sciences,184/4,Kamarajar Nagar,Ammanambakkam,Chengalpattu. |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: E669||Obesity, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NOT APPLICABLE |
NOT APPLICABLE |
| Intervention |
Plantain Leaf Bath |
On the day of the plantain leaf bath, participants will slowly drink approximately 1.5 liters of water in the morning. The intervention will be conducted between 8:00 and 11:00 AM. Participants will lie down on banana leaves spread on the open ground or terrace, with their entire body covered by plantain (banana) leaves, leaving only a small opening near the nose or mouth for breathing. This plantain leaf bath will be administered on three alternate days each week, continuing for eight weeks. After resting under the leaves, participants will be exposed to sunlight for 20 minutes, followed by a one-minute cold water affusion (pouring of cold water) to conclude the session. If any adverse event occurs, the procedure will be stopped immediately. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Female |
| Details |
BMI of 25 to 40 Kg/m² |
|
| ExclusionCriteria |
| Details |
Self reported moderate-to-vigorous exercise,
Engaged in any style of yoga,
Reported weight loss of greater than 3% or participating in a weight reduction diet,
Female and pregnant or breastfeeding,
Reporting a planned pregnancy during the study period,
Resting systolic blood pressure of greater than 160 mmHg or resting diastolic blood pressure of greater than 100 mmHg,
History of alcohol or substance abuse,
Currently treated for psychological issues (i.e.,depression,bipolar disorder,etc.)
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Outcome Assessor Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The body composition (1500) diverse body fat measurements were evaluated through multifrequency bioelectrical impedance analysis (BIA) using the Bodystat 1500 device (manufactured by Bodystat, Isle of Man, UK).An excitation current was applied to the distal electrodes and the voltage drop was detected by proximal electrodes (Bodystat 1500 and Dualscan 2005) and ECW (Bodystat Dualscan 2005) |
Proximal electrodes (Bodystat 1500 and Dualscan 2005) and ECW (Bodystat Dualscan 2005)will be assessed a day before and after intervention |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Impedance 50khz ,Total Body Fat ,Total Fat weight (Kg), Lean body weight (Kg), Total body weight (Kg), Basal metabolic rate (kcal), BMI (Kg/m²), Total Cholesterol, HDL, LDL, CRP |
Lipid profile,HDL,LDL,CRP will be assessed a day before and after the intervention |
|
|
Target Sample Size
|
Total Sample Size="40" Sample Size from India="40"
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
|
Phase 2 |
|
Date of First Enrollment (India)
|
07/08/2025 |
| 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="0" Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
Obesity is a growing global health concern, associated with
numerous chronic diseases, including diabetes, cardiovascular conditions,
Dyslipidemia, and metabolic syndrome. Dyslipidemia is characterized by abnormal
lipid levels in the bloodstream, which can increase the risk of cardiovascular
diseases . There are many reasons why some people have trouble losing weight.
Often, obesity results from inherited, physiological, and environmental
factors, combined with diet, physical activity, and exercise choices. Traditional
approaches to managing obesity often focus on dietary changes and physical
activity; however, complementary therapies are gaining attention for their
potential benefits One such therapy is the use of plant-based treatments, with
plantain leaves emerging as a promising candidate. Plantain leaves have been
traditionally used in various cultures for their medicinal properties,
including anti-inflammatory and antioxidant effects . Recent studies suggest
that herbal baths may influence body composition, improve skin health, and
enhance overall well-being. A notable study investigated the impact of banana
leaf baths a practice where individuals lie under direct sunlight covered with
banana leaves on cardiovascular parameters such as blood pressure and pulse
rate . Also, some studies included that Obesity is recognized as a
heterogeneous condition in which individuals with similar BMIs may have
distinct metabolic and CVD risk profiles. Thus, susceptibility to
obesity-related cardiovascular complications is not mediated solely by overall
body fat mass but depends largely on individual differences in regional body
fat distribution, which negatively affect cardiac, structure and function .
This pilot study aims to investigate the effects of plantain leaf baths on body
composition among individuals with obesity, exploring whether this natural
remedy can serve as an adjunct to conventional weight management strategies. By
examining changes in body mass index (BMI), body fat percentage, and other
health markers, this research seeks to provide preliminary insights into the
efficacy of plantain leaf baths. |