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CTRI Number  CTRI/2023/08/056858 [Registered on: 24/08/2023] Trial Registered Prospectively
Last Modified On: 23/08/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   Seenthil Chooranam for Type II Diabetes Mellitus  
Scientific Title of Study   Phase II non randomized open clinical evaluation of Siddha medicine Seenthil Chooranam for the management of Madhumegam (Type II Diabetes Mellitus) 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Rohini alias Elavarasi J 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College,Chennai 
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9003988208  
Fax    
Email  rohinielavarasi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Menaka R 
Designation  Lecturer 
Affiliation  Government Siddha Medical College,Chennai 
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College,Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9444669661  
Fax    
Email  rangasamymenaka75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Rohini alias Elavarasi J 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College,Chennai 
Address  Post Graduate Department of Pothu Maruthuvam, Government Siddha Medical College,Arumbakkam, Chennai.

Chennai
TAMIL NADU
600106
India 
Phone  9003988208  
Fax    
Email  rohinielavarasi@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, Arumbakkam, Chennai. 
 
Primary Sponsor  
Name  J Rohini alias Elavarasi 
Address  Post Graduate Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai 
Type of Sponsor  Other [Self] 
 
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 J Rohini alias Elavarasi   Government Siddha Medical College  Room no. S1, Department of PG Pothu MaruthuvamArumbakkam Chennai
Chennai
TAMIL NADU 		 9003988208

rohinielavarasi@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethics Committee of GSMC, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: E119||Type 2 diabetes mellitus without complications,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not Applicable  Not Applicable 
Intervention  SEENTHIL CHOORANAM  This siddha drug will be given as 1gram, BD dose with Ghee, for 90 days, for the management of Type 2 Diabetes Mellitus. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1 Sex: All Gender
2 Polyuria
3 Polyphagia
4 Polydipsia
5 Nocturia
6 HbA1C - 6.5% to 9%
 
 
ExclusionCriteria 
Details  1 Pregnant women
2 Lactating mothers
3 Insulin dependent Diabetes mellitus
4 Cardiovascular disease
5 Diabetic nephropathy
6 Diabetic retinopathy
• Recently diagnosed patient with tuberculosis
• HbA1c > 9%
The above criteria will be excluded clinically or based on the available medical reports. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
Reduction in HbA1C level (at least 20%)  90 Days 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in clinical symptoms like Polyuria,Polydipsia,Polyphagia & Fatigue.  90 Days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   01/09/2023 
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Statistical Analysis Plan
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Anyone

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [rohinielavarasi@gmail.com].

  6. For how long will this data be available start date provided 01-06-2024 and end date provided 01-12-2024?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - Nil
Brief Summary  

Diabetes mellitus is a clinical syndrome characterised by increase in plasma blood glucose (Hyperglycemia). There are two types of diabetes mellitus ,Type I and Type II. Type I Diabetes Mellitus is caused by autoimmune destruction of beta cells in the pancreas, resulting in absolute insulin deficiency, whereas Type I  Diabetes Mellitus is due to insulin deficiency or defective action of insulin or both. Chronic hyperglycemia is responsible for diabetes specific microvascular complications affecting the eyes (retinopathy), kidneys (nephropathy) and feet (neuropathy).

India is deemed as the world’s capital of Diabetes. In 2021, approximately 537 million adults (20-79years of age ) are living with diabetes. The total number of people living with diabetes is projected to rise to 643 million by 2030 and 783 million by 2045.The diabetic population in the country close to hitting the alarming mark of 69.9 million by2030.

The classical siddha medicine formulation â€œSEENTHIL CHOORANAM” mentioned in "The Siddha Formulary of India-Part I ". is indicated for Madhumegam (Diabetes mellitus). Moreover this formulation has anti-diabetic activity that had been proven scientifically .So the author tries to evaluate its efficacy in the management of Type II Diabetes Mellitus)in a non-randomised open clinical trial.


 
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