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CTRI Number  CTRI/2024/05/067698 [Registered on: 21/05/2024] Trial Registered Prospectively
Last Modified On: 15/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Other 
Public Title of Study   Athimathura Chooranam for High Blood Pressure 
Scientific Title of Study   Single centric Non- Randomised open clinical trial Phase ll in Uratha Pitha Vatham (Essential Hypertension) with the Siddha medicine Athimathura chooranam among patients attending OPD at Government Siddha Medical College Hospital Chennai 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  Dr N Rakshana 
Designation  PG Scholar 
Affiliation  Government Siddha Medical College,Arumbakkam 
Address  Room no S1 Department of PG Pothu maruthuvam,Government Siddha Medical College Arumbakkam Chennai India Chennai TAMIL NADU 600106 India
Room no S1 Department of PG Pothu maruthuvam,Government Siddha Medical College Arumbakkam Chennai India Chennai TAMIL NADU 600106 India
Chennai
TAMIL NADU
600106
India 
Phone  9498438428  
Fax    
Email  rakzvic@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr U Chitra 
Designation  Lecturer 
Affiliation  Government Siddha Medical College,Arumbakkam 
Address  Room no S1 Government Siddha Department of PG Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai India Chennai TAMIL NADU
Room no S1 Government Siddha Department of PG Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai India Chennai TAMIL NADU
Chennai
TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr U Chitra 
Designation  Lecturer  
Affiliation  Government Siddha Medical College,Arumbakkam 
Address  Room no S1 Government Siddha Medical College Arumbakkam Chennai India Chennai TAMIL NADU
Room no S1 Government Siddha Medical College Arumbakkam Chennai India Chennai TAMIL NADU
Chennai
TAMIL NADU
600106
India 
Phone  9445716802  
Fax    
Email  mmsankar2000@gmail.com  
 
Source of Monetary or Material Support  
Government Siddha Medical College, Arumbakkam, Chennai 600106 Tamil Nadu India  
 
Primary Sponsor  
Name  N RAKSHANA 
Address  Department of Pothu Maruthuvam Government Siddha Medical College Arumbakkam Chennai 600 106 Tamil Nadu, India 
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 
DrN Rakshana  Government Siddha Medical College, Arumbakkam, Chennai.  Room no S1,Department of PG Pothu Maruthuvam,Government Siddha Medical College, Arumbakkam, Chennai,TAMIL NADU
Chennai
TAMIL NADU 		 9498438428

rakzvic@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Instituitional Ethical 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 
Intervention  Athimathura Chooranam  Athimathuram Inji Thipilli Elam Seeragam Nattu sakarai. The above mentioned drugs will be purified and pulverised. After mixing well the powder will be mixed with nattu sakarai and kept in a air tight container. Duration : 48 days Dosage : 1gm Twice a day Oral route adminisation Adjuvant : Cows Milk 
Comparator Agent  NA  NA 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details   Grade 1
SBP ≥140 mmHg and 159 mmHg
DBP ≥90 mmHg and 99 mmHg
 Grade 2
SBP ≥160 mmHg and 179mmHg
DBP≥100 mmHg and 109mmHg
 
 
ExclusionCriteria 
Details   Age above 60 yrs
 Vulnerable Population.
 Associated Serious Illness.
 Grade III SBP ≥180 mmHg DBP ≥110 mmHg
 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of this treatment will be as follows.The blood pressure reduction of 80% is taken as good,reduction in 50% is taken as moderate,20% reduction is taken as poor.

 		 3 Months

 
 
Secondary Outcome  
Outcome  TimePoints 
Reduction in Total Cholesterol levels  3 Months 
 
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)   09/09/2024 
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 -  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 (Others) -  Nil

  6. For how long will this data be available start date provided 05-06-2025 and end date provided 31-12-2026?
    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 or high blood pressure is a chronic condition in which blood pressure in arteries is higher than the normal. This condition can put extra strain on the heart and circulatory system , which must work harder to circulate the blood. Hypertension is a major risk factor for variety of cardiovascular diseases , including coronary artery disease , heart failure ,stroke and peripheral vascular disease. 


The aim of the study is the clinical management of Uratha Pitha Vatham (ESSENTIAL HYPERTENSION) with the siddha trial Medicine Athimathura Chooranam. Thus in Siddha system of Medicine , there are unique combination of medicines which have the solution to Hypertension. One such combination is Athimathura Chooranam which is mentioned in Pathartha Guna Vilakam. The hypothesis is created in such a way  to evaluate the efficacy of Athimathura Chooranam in the management of Hypertension. 
 
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