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CTRI Number  CTRI/2024/05/068059 [Registered on: 29/05/2024] Trial Registered Prospectively
Last Modified On: 06/11/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study To Evaluate The Effectiveness Of Siddha Formulation Drakshai Chooranam In The Management Of Essential Hypertension among The Patients Attending Ayothidass Pandithar Hospital Nis  
Scientific Title of Study   Clinical Evaluation Of Siddha Formulation Drakshai Chooranam In The Management Of Essential Hypertension among The Patients Attending Ayothidass Pandithar Hospital Nis  
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 C Cilfa 
Designation  II year pg scholar Department of Maruthuvam 
Affiliation  National Institute Of Siddha 
Address  Department of Maruthuvam National Institute of siddha Tambaram sanitorium TAMIL NADU 600047
Department of Maruthuvam National Institute of siddha Tambaram sanitorium TAMIL NADU 600047
Chennai
TAMIL NADU
600047
India 
Phone  9500525364  
Fax    
Email  cilfajac@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Associate Professor 
Affiliation  National Institute Of Siddha 
Address  Department of Maruthuvam National Institute of siddha Tambaram sanitorium TAMIL NADU 600047
Department of Maruthuvam National Institute of siddha Tambaram sanitorium TAMIL NADU 600047
Chennai
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Vetha Merlin Kumari 
Designation  Associate Professor 
Affiliation  National Institute Of Siddha 
Address  Department of Maruthuvam National Institute of siddha Tambaram sanitorium TAMIL NADU 600047
Department of Maruthuvam National Institute of siddha Tambaram sanitorium TAMIL NADU 600047
Chennai
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Source of Monetary or Material Support  
National Institute Of Siddha Tambaram Sanatorium Chennai 600047 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 7/8 Department of maruthuvam National Institute of Siddha Kancheepuram 
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 C Cilfa  National Institute Of Siddha  Room no 7 Department of maruthuvam National Institute Of Siddha Tambaram Sanatorium
Chennai
TAMIL NADU 
9500525364

cilfajac@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
National Institute Of Siddha  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Healthy Human Volunteers  essential hypertension 
Patients  (1) ICD-10 Condition: I10||Essential (primary) hypertension,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Drakshai chooranam  20g of Drakshai chooranam will be dispensed in a air tight container once in 7 days for 48 days 
Comparator Agent  NIL  NIL 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Age 18 to 59 years(All Gender)
Stage I hypertension (According to JNC 8 guidelines)
 
 
ExclusionCriteria 
Details  Age above 60 years
K/c/o liver diseases
kidney disease
hematopoietic disease
malignant tumour
cardiovascular diseases
cerebrovascular diseases
white collar hypertension
Stage 2 hypertension
Pregnant women
Patients who are taking anti-hypertensive medications

 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the clinical effectiveness of siddha formulation Drakshai chooranam in the management of Essential hypertension through sphygmomanometer  4 months screening
4 months patient enrollment
4 months outcome assessment 
 
Secondary Outcome  
Outcome  TimePoints 
To assess the quality of life in patients with hypertension through SF-36 questionnaire   4 months screening
4 months patient enrollment
4 months outcome assessment 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="30" 
Phase of Trial   Phase 3 
Date of First Enrollment (India)   16/06/2024 
Date of Study Completion (India) 15/08/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  

BACKGROUND:

                   Siddha system of medicine provides rejuvenated health care based on the principles of panchayat boodham. The Siddha medicines are broadly classified into 32 Internal medicines & 32 external medicines which play a significant role in the treatment & management of various diseases.

Hypertension is a very common disorder that doubles the risk of cardiovascular diseases, including coronary heart disease(CHD), congestive heart failure(CHF), ischemic and hemorrhagic stroke, renal failure, and peripheral arterial disease(PAD).

The pathogenesis of Essential hypertension is not clearly understood. Different investigators have proposed the kidney, the peripheral resistance vessels and the sympathetic nervous system as the seat of primary abnormality.

 In reality, the problem is probably multi-factorial. Hypertension is more common in some ethnic groups and approximately 40 to 60 % is explained by genetic factors Important environmental factors include a high salt intake, heavy consumption of alcohol, obesity, lack of exercise and impaired intrauterine growth.

Hypertension occasionally causes headaches but, most patients remain asymptomatic. Accordingly, the diagnosis is usually made at a routine examination or when a complication arises. A blood pressure check is advisable every 5 years in adults.

An estimated 1.28 billion adults aged 30-79 years worldwide have hypertension, most (two-thirds)living in low- and middle-income countries. An Estimated 46% of adults with hypertension are unaware and less than half of adults (42%) are diagnosed and treated.

One of the global targets for non-communicable diseases is the reduction of the prevalence of hypertension by 33% between 2010 and 2030. It is estimated that at least one in four adults in India has hypertension, but only 12% of them have their blood pressure under control.

India has set a target of a 25% relative reduction in the prevalence of hypertension (raised blood pressure) by 2025. The overall prevalence of hypertension was 33% and higher among sedentary type (41%) in Tamil Nadu

PRIMARY OBJECTIVE:

To evaluate the clinical effectiveness of siddha formulation DRAKSHAI CHOORANAM  in the management of  Essential hypertension through sphygmomanometer

SECONDARY OBJECTIVE:

                               To assess the quality of life in patients with hypertension through the SF-36 questionnaire 

STUDY DESIGN:

                              An open non non-randomised clinical trial with 30 patients diagnosed with essential hypertension reporting at Ayothidass Pandithar Hospital National Institute of Siddha will be enrolled in the study. Patients with Stage I  systolic ≥140-≤159/ diastolic ≥90-≤99 mmHg (According to JNC 8 guidelines) will be included and patients with Stage 2 systolic   ≥160 / diastolic ≥110 mmHg, K/c/o  diabetes mellitus, liver diseases, kidney disease, hematopoietic disease, malignant tumour, cardiovascular diseases, cerebrovascular diseases, white collar hypertension and pregnant women are excluded. The trial drug Drakshai chooranam as internal medicine will be given for 48 days along with 2 month follow up

 

 
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