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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  
Name  Address 
Nil  Nil 
 
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  
Status 
Not Applicable 
 
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.


 
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