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CTRI Number  CTRI/2025/02/080427 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 14/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   Clinical trial on hypertension with the intervention of Siddha drug Seenthil chooranam 
Scientific Title of Study   Single centric non-randomized open clinical trial phase II in uratha pitha vatham (Essential Hypertension)with the Siddha medicine Seenthil chooranam among patients attending OPD at Government Siddha Medical College, Chennai 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  M Sharmila 
Designation  PG scholar 
Affiliation  Government Siddha Medical College, Arumbakkam, Chennai 
Address  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  8903320156  
Fax    
Email  sharmilamuthu99@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr R Menaka 
Designation  Lecturer 
Affiliation  Government Siddha Medical College, Arumbakkam, Chennai 
Address  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  6380932382  
Fax    
Email  rangasamymenaka75@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr R Menaka 
Designation  Lecturer 
Affiliation  Government Siddha Medical College, Arumbakkam, Chennai 
Address  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai

Chennai
TAMIL NADU
600106
India 
Phone  6380932382  
Fax    
Email  rangasamymenaka75@gmail.com  
 
Source of Monetary or Material Support  
No 6, Government Siddha Medical College,Anna arch road, Arumbakkam, Chennai-600106 
 
Primary Sponsor
Modification(s)  
Name  M Sharmila 
Address  Department of Pothu Maruthuvam, Room no 1 Government Siddha Medical College, Arumbakkam, Chennai-600106 
Type of Sponsor  Government medical college 
 
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 Sharmila M  Government Siddha Medical College, Arumbakkam, Chennai  Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU 		 8903320156

sharmilamuthu99@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, Government Siddha Medical College, Arumbakkam, Chennai  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Not applicable  Not applicable 
Intervention  Seenthil Chooranam  Stem of Purified Tinospora cordifolia will be peeled, powdered and washed for 21 times in pure water and dried. Then Cow milk will be sprinkled over the powder and dried.The whole plant of Eclipta alba will be washed, dried in shade and powdered.Purified Earthworm will be dried in sunlight and powdered. The powdered ingredients will be mixed and stored in an airtight container. 1.5 gram will be given twice daily with ghee for 48 days. 
 
Inclusion Criteria  
Age From  30.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Pre hypertension stage and Stage I hypertension according to JNC 8 guidelines will be included 
 
ExclusionCriteria 
Details  Age above 60 years
Stage II hypertension
Vulnerable population and patients with associated serious systemic illness. 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The Patients who are classified as prehypertension stage will be managed to normal stage. The patients who are classified as stage I hypertension will be managed to prehypertension stage or normal stage.  48 days 
 
Secondary Outcome  
Outcome  TimePoints 
The reduction in the lipid profile  48 days 
 
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)   20/02/2025 
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 - 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 -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    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 - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [sharmilamuthu99@gmail.com].

  6. For how long will this data be available start date provided 24-01-2025 and end date provided 31-12-2027?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - nil
Brief Summary   Hypertension is a common disorder in the past middle age, doubling the risk of cardiovascular diseases. Seenthil chooranam mentioned in Agastiyar paripooranam 400 is indicated in the treatment of uratha pitha vatham(Hypertension). The components of the medicine include Tinospora cordifolia, Eclipta alba, Earthworm. The constituents of the medicine possess anti-hypertensive , antioxidant and diuretic properties. The aim of the study is the clinical management of uratha pitha vatham(Hypertension )with the Siddha medicine Seenthil chooranam.  
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