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CTRI Number  CTRI/2025/05/087168 [Registered on: 20/05/2025] Trial Registered Prospectively
Last Modified On: 15/04/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Siddha 
Study Design  Single Arm Study 
Public Title of Study   A Study on Siddha Formulation Seedhobalathi Chooranam for Kuruthi Azhal Noi (Essential Hypertension) 
Scientific Title of Study   Clinical Evaluation of Siddha Formulation Seedhobalathi Chooranam in the Management of Kuruthi Azhal Noi (Essential Hypertension) Among the Patients Attending Ayothidoss Pandithar Hospital, National Institute of Siddha 
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 Pooja R M 
Designation  PG Scholar 
Affiliation  National institute of siddha 
Address  Room no 7/8,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  6369850332  
Fax    
Email  poojarmsiddha@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr H Vetha Merlin Kumar 
Designation  Professor 
Affiliation  National institute of siddha 
Address  Room no 7/8,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai

Kancheepuram
TAMIL NADU
600047
India 
Phone  9894782366  
Fax    
Email  dr.vetha@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr H Vetha Merlin Kumar 
Designation  Professor 
Affiliation  National institute of siddha 
Address  Room no 7/8,Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, 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-47 
 
Primary Sponsor  
Name  National Institute of Siddha 
Address  Room no 7/8, Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-47  
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 Pooja R M  Ayothidoss Pandithar Hospital  Department of Maruthuvam, National Institute of Siddha, Tambaram Sanatorium, Chennai-600047
Kancheepuram
TAMIL NADU 
6369850332

poojarmsiddha@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONAL ETHICS COMMITTEE NATIONAL INSTITUTE OF SIDDHA CHENNAI - 600 047  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  NIL  NIL 
Intervention  Seedhobalathi Chooranam  3 grams of Seedhobalathi Chooranam with milk twice a day after food for 48 days. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  59.00 Year(s)
Gender  Both 
Details  Stage I Hypertension according to Joint National
Committee 8 guidelines 
 
ExclusionCriteria 
Details  K/c/o liver diseases, kidney disease, hematopoietic disease, malignant tumor, cardiac diseases, cerebrovascular diseases, white collar hypertension.
Patients who are taking anti-hypertensive medication 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
The changes in systolic and diastolic blood pressure will be assessed before and after treatment
( according to JNC 8 guidelines). 
48 days 
 
Secondary Outcome  
Outcome  TimePoints 
The quality of life in patients with hypertension through SF-36 questionnaire will be assessed
before and after treatment. 
48 days 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   03/07/2025 
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="1"
Months="0"
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 - NO
Brief Summary  

BACKGROUND:

 

         Siddha system of medicine provides rejuvenate health care based on the principles of pancha Bootham. The Siddha medicines are broadly classified into 32 Internal medicines & 32 External medicines which plays a significant role in the treatment & management of various disease.Hypertension is one of the major public health problems around the globe and its prevalence is rapidly increasing among developing countries. It’s important to note  that increase in hypertension directly contribute on even more serious conditions like strokes, diabetes, heart diseases and renal impairment.Therefore management of  hypertension has become a biggest challenge in developing country like India. Hypertension, commonly known as high blood pressure defined with standard criteria as systolic BPgreater than or equal to 140 mmHg and diastolic BP greater than or equal to 90 mmHg. Prevalence of hypertension in India is at alarming level and is estimated to account for 10.8% of all the deaths in the country.Lack of awareness is one of the major factor leads to increased prevalence of  hypertension in India. Many people are not aware about their hypertension condition,even in some cases the reason for death remains elusive as most of the time person suffering from hypertension do not show any visible symptoms, remains normal and diagnosed only after appearance of cardio vascular disease or stroke.According to the global burden of diseases estimate 2015, hypertension is a most important cause of mortality. It is estimated that, 57% and 24% of stroke and coronary artery disease-related deaths respectively are due to hypertension.

            In Siddha, various botanical species and their preparations have proven to be advantageous in the management of cardiovascular ailments. Multiple pieces of data exist that demonstrate the efficacy of different Siddha medications in treating cardiovascular problems. The clinical trial indicates that marudham pattai is effective in treating congestive heart failure, chronic stable angina, and hypertension. The marudham pattai tree and its components, such as arjunolic acid, exhibit a cardioprotective effect in rats by virtue of their antioxidant activity . The alcoholic extract derived from the bulb of Allium ascalonicum demonstrates a favourable impact on the proteolytic and hypocholesterolemic activity in rabbits . The rhizome of Curcuma longa Linn, also known as turmeric, and its active compound curcumin, have demonstrated a hypolipidemic impact, anti  atherosclerotic activity, and antithrombotic effect. Recent research have shown that natural components effectively inhibit, regulate, and impede key factors associated with cardiovascular disease, such as oxidative stress and inflammatory mediators. Medicinal herbs have been beneficial in treating individuals with congestive heart failure, systolic hypertension, angina pectoris, atherosclerosis, cerebral insufficiency, and venous insufficiency..

    OBJECTIVE:

PRIMARY OBJECTIVE:

To evaluate the clinical effectiveness of siddha formulation  Seedhobalathi Chooranam in the management of Essential hypertension (according to Joint Nationl Committee 8 guideliness) among the patients attending Ayothidoss Pandithar Hospital, National Institute of Siddha.

SECONDARY OBJECTIVE:

The Quality of life in patients with hypertension through SF-36             Questionnaire will be assessed before and after treatment.

STUDY DESIGN:

This is an interventional study of Non randomized sampling which will be carried out for 1 year in patients with Essential hypertension reporting at Ayothidoss Pandithar Hospital, National Institute of Siddha, Chennai – 600 047 with 30 participants as sample size. Participants with age 18 to 59 years of both sex, Participants with Stage 1 Hypertension according to JNC 8 guidelines will be included in this study. Participants with liver diseases, kidney disease, hematopoietic disease, malignant tumor, cardiac diseases,  cerebrovascular diseases, white collar hypertension, Pregnant women. Patient who are taking anti-hypertensive medication will been excluded in this study.

OUTCOME: 

PRIMARY OUTCOME:

The changes in  systolic and diastolic blood pressure will be assessed  before and after treatment according to JNC 8  guidelines.

 SECONDARY OUTCOME:

The quality of life in patients with hypertension through SF-36 questionnaire will be assessed before and after treatment.

RESULTS AND DISCUSSION:

The results will be statistically analyzed and reported.

KEYWORDS: Kuruthi azhal noi, Essential Hypertension, Seedhobalathi chooranam, Siddha Medicine.


 
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