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CTRI Number  CTRI/2024/05/068040 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 29/05/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Non-randomized, Multiple Arm Trial 
Public Title of Study   Munthirigai chooranam and Siddhar yogam for Primary Hypertension 
Scientific Title of Study   Evaluation of the therapeutic effectiveness of Siddhar Yogam and Munthirigai chooranam in the management of Kurthi Azhal noi (Primary Hypertension) patients reporting at Ayothidoss Pandithar Hospital of National Institute of Siddha, Chennai-A Comparative Non-randomized Double arm Clinical trial 
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 P Manivannan 
Designation  Postgraduate Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Siddhar Yoga maruthuvam National Institute of Siddha Tambaram sanatorium Chennai TAMILNADU

Kancheepuram
TAMIL NADU
600047
India 
Phone  7010223758  
Fax  22381314  
Email  surimani211298@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr V Mahalakshmi 
Designation  Associate Professor 
Affiliation  National Institute of Siddha 
Address  Department of Siddhar Yoga Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai TAMILNADU

Kancheepuram
TAMIL NADU
600047
India 
Phone  9444519975  
Fax  22381314  
Email  rvmahalakshmi85@gmail.com  
 
Details of Contact Person
Public Query  
Name  Dr P Manivannan 
Designation  Postgraduate Scholar 
Affiliation  National Institute of Siddha 
Address  Department of Siddhar Yoga Maruthuvam National Institute of Siddha Tambaram Sanatorium Chennai TAMILNADU

Kancheepuram
TAMIL NADU
600047
India 
Phone  7010223758  
Fax  22381314  
Email  surimani211298@gmail.com  
 
Source of Monetary or Material Support  
NIL 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  National Institute of Siddha Tambaram Sanatorium Chennai 600047 TAMILNADU 
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 Manivannan P  Ayothidoss Pandithar Hospital  OPD NO : 13 Ayothidoss Pandithar Hospital National Institute of Siddha Tambaram Sanatorium Chennai Tamil Nadu
Kancheepuram
TAMIL NADU 		 7010223758
22381314
surimani211298@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
THE INSTITUTIONAL ETHICS COMITTEE, NATIONAL INSTITUTE OF SIDDHA  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  Internal medicine - Munthirikai chooranam  Drug : Munthirigai chooranam Dosage : 1 gram (twice a day after food with hot water) Duration : 48 days 
Intervention  Siddhar Yogam  30 minutes of Yogam practice Duration:48 days  
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1.Primary hypertension
Grade 1 hypertension: SBP 140 to 159mmHg and/or DBP 90 to 99mmHg
2.Patients who are willing to provide blood sample for investigation before and after treatment.
3.Patient who are willing to sign in the consent form.
 
 
ExclusionCriteria 
Details  1.Secondary hypertension
2.Obesity (BMI-30 and above)
3.Pregnancy and Lactation
4.Alcoholism and Smoking
5.Patient with any other severe systemic disorder 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The outcome of the study will be assessed by reduction in Systolic Blood pressure less than 85
and Diastolic Blood pressure less than 130 after the treatment. 		 SCREENING - 3 MONTHS
PATIENT ENROLLMENT - 5 MONTHS
TRIAL DRUG - 2 MONTHS
DATA ANALYSIS - 1 MONTHS
FOLLOW UP - 3 MONTHS 
 
Secondary Outcome  
Outcome  TimePoints 
NIL  NIL 
 
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)   09/06/2024 
Date of Study Completion (India) Applicable only for Completed/Terminated trials 
Date of First Enrollment (Global)  09/06/2024 
Date of Study Completion (Global) Applicable only for Completed/Terminated trials 
Estimated Duration of Trial   Years="1"
Months="6"
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   Hypertension is one among the lifestyle modification disorders. Hypertension also known as high or raised blood pressure that can increase the risk of heart, brain, kidney and other diseases. In the Siddha concept, it is correlated to the Kuruthi azhal noi.Hence considerably more patients of Hypertension have been recorded in the Ayothiyadoss pandithar hospital, the Siddha formulation Munthirigai chooranam is said to be cost effective, simple formulation and has anti-hypertensive, diuretic and antioxidant property. Yogasanam plays an important role in the management of Hypertension, yogam reduces perceived stress and exerts positive effects on blood pressure. Yoga and meditative practices, including mindfulness-based interventions, provide the tools to manage this cardiovascular reactivity through restoration of psycho physiological balance. So, I hope Yogasanam and Munthinigai chooranam will be effective in the treatment of hypertension. 
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