| 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
|
|
|
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
|
|
|
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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