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CTRI Number  CTRI/2025/06/088981 [Registered on: 17/06/2025] Trial Registered Prospectively
Last Modified On: 16/06/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A study to evaluate if siddha medicine can help reduce weight and body measurements in people with moderate obesity  
Scientific Title of Study   An open labelled single centric prospective clinical trial for evaluating the therapeutic efficacy of a Siddha regimen in the management of Athithoolam Atitula noy obesity Class I and II 
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 Ilanchezhiyan S 
Designation  PG Scholar 
Affiliation  National Institute of Siddha 
Address  room no 10,11 Department of Gunapadam National Institute of Siddha Tambaram Sanatorium Chennai 47
room no 10,11 Department of Gunapadam National Institute of Siddha Tambaram Sanatorium Chennai 47
Chennai
TAMIL NADU
600047
India 
Phone  8610004064  
Fax    
Email  chezhiyanilan@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr G Senthilvel  
Designation  Head of the department  
Affiliation  National Institute of Siddha 
Address  room no 10,11 Department of Gunapadam National Institute of Siddha Tambaram Sanatorium Chennai 47

Chennai
TAMIL NADU
600047
India 
Phone  8925856333  
Fax    
Email  siddha.senthilvel@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr G Senthilvel  
Designation  Head of the department  
Affiliation  National Institute of Siddha 
Address  room no 10,11 Department of Gunapadam National Institute of Siddha Tambaram Sanatorium Chennai 47

Chennai
TAMIL NADU
600047
India 
Phone  8925856333  
Fax    
Email  siddha.senthilvel@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Siddha, Tambaram Sanatorium Chennai 47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha, Tambaram Sanatorium,Chennai 47 
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 G Senthilvel  Ayothidoss Pandithar Hospital  Room no 10,11, Department of Gunapadam, Ayothidoss Pandithar Hospital, National Institute of Siddha, Tambaram Sanatorium Chennai 47
Chennai
TAMIL NADU 		 89258 56333

siddha.senthilvel@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Certificate of Approval  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 
Intervention  Karunjeeraga Chooranam Naththaichoori chooranam Kukil parpam tablet   Karunjeeraga Chooranam 2 gm Naththaichoori chooranam 2 gm Kukil parpam tablet 2 nos Will be given twice a day for 48 days followed by a period of 7 day drug holiday after which the trial regimen will be given again for a period of 48 days  
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  K/C/O Diabetes Mellitus
Obesity – BMI greater than or equal to 30 kg/m^2
Obesity class I – BMI 30 to 34.9 kg/m^2
Obesity class II – BMI 35 to 39.9 kg/m^2 
 
ExclusionCriteria 
Details  Vulnerable groups (Pregnancy and lactation)
Hypothyroidism
Malignancy
The patient is not willing to undergo laboratory investigations 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
A 5 to 10 percent reduction in BMI and a reduction in anthropometric measurements from
baseline to endpoint 		 103 days 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the difference in laboratory parameters and Enhanced Quality of Life from
baseline to endpoint 		 103 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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/ Phase 3 
Date of First Enrollment (India)   30/06/2025 
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="0"
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 open-labelled, single-centric, prospective clinical trial aims  to evaluate the therapeutic efficacy of a Siddha regimen (Karunjeeraga Chooranam, Kukil parpam tablet, Naththaichoori chooranam) at Ayothidoss Pandithar Hospital Chennai, in managing Class 1 and 2 obesity. Participants aged between 18 and 60 years with a BMI greater than or equal to 30 kg/m², who meet the specified inclusion and exclusion criteria, will be enrolled in the trial. They will receive the trial regimen for an initial period of 48 days, followed by a 7-day drug-free interval, and then continue the regimen for an additional 48 days. The primary objective is to achieve a 5-10% reduction in BMI and anthropometric measurements, while secondary objectives include assessing changes in laboratory parameters and quality of life. The study excludes vulnerable groups, hypothyroidism, and malignancy, aiming to provide evidence on the efficacy of Siddha medicine in obesity management. 
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