| CTRI Number |
CTRI/2023/10/058516 [Registered on: 11/10/2023] Trial Registered Prospectively |
| Last Modified On: |
10/01/2026 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Efficacy of Siddha Polyherbal formulation
Venthamarai Chooranam against high blood pressure - A Clinical Trial |
|
Scientific Title of Study
|
Therapeutic effect of Siddha medicine in hypertension patients – a Randomized Control Trial in government Primary Health Center, Tamil Nadu |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrPSelva Shunmugam |
| Designation |
President |
| Affiliation |
Global Center for Siddha Medicine and Research |
| Address |
Member, Scientific Advisory Committee, Global Center for Siddha Medicine and Research, 31, Venkat Narayana Road, Thyagaraya Nagar
Chennai
TAMIL NADU
600017
India |
| Phone |
09894828968 |
| Fax |
|
| Email |
siddhaselva@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
GJChristian |
| Designation |
Professor |
| Affiliation |
National Institute of Siddha is affiliated to The TN. Dr. M.G.R. Medical University |
| Address |
Teaching block 2, Department of Noi Naadal, National Institute of Siddha
Chennai
TAMIL NADU
600047
India |
| Phone |
9962545930 |
| Fax |
|
| Email |
christianvijila@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
P.SelvaShunmugam |
| Designation |
President |
| Affiliation |
President, Global Center for Siddha Medicine and Research |
| Address |
Member, Scientific Advisory Committee, Global Center for Siddha Medicine and Research, 31, Venkat Narayana Road, Thyagaraya Nagar
Chennai
TAMIL NADU
600017
India |
| Phone |
9894828968 |
| Fax |
|
| Email |
siddhaselva@gmail.com |
|
|
Source of Monetary or Material Support
|
| Global Center for Siddha Medicine and Research, 31, Venkat Narayana Road, Thyagaraya Nagar |
|
|
Primary Sponsor
|
| Name |
Global Center for Siddha Medicine and Research |
| Address |
Global Center for Siddha Medicine and Research
31 Venkatanarayana Road
Thyagarajanagar
Chennai 600017 |
| Type of Sponsor |
Private hospital/clinic |
|
|
Details of Secondary Sponsor
|
|
|
Countries of Recruitment
|
India |
Sites of Study
Modification(s)
|
| No of Sites = 3 |
| Name of Principal
Investigator |
Name of Site |
Site Address |
Phone/Fax/Email |
| DrPSelva Shunmugam |
Government Primary Health Centre, Mangadu, Kanchipuram |
Primary Health Centre Mangadu,Kunrathur Road, Karim Nagar, Mangadu, Chennai, 600122
Chennai
TAMIL NADU |
09894828968
siddhaselva@gmail.com |
| Dr P Selva Shunmugam |
Health India Foundation |
Room No.4 31 Venkatnarayana Road Thyagaraya Nagar Chennai 600017
Chennai
TAMIL NADU |
09894828968
siddhaselva@gmail.com |
| Prof Dr G J Christian |
National Institute of Siddha |
OPD No 20 21 Department of Noi Naadal National Institute of Siddha
Chennai
TAMIL NADU |
9962545930
christianvijila@gmail.com |
|
Details of Ethics Committee
Modification(s)
|
| No of Ethics Committees= 4 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committe Directorate of Public Health & Preventive Medicine |
Approved |
| Institutional Ethics Committe Directorate of Public Health & Preventive Medicine |
Approved |
| Institutional Ethics Committee Directorate of Public Health and Preventive Medicine |
Approved |
| Institutional Ethics Committee Directorate of Public Health and Preventive Medicine |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Amlodipine 2.5mg twice a day. |
Amlodipine 2.5mg twice a day for 3 months. |
| Intervention |
Venthamarai Chooranam
|
Venthamarai Chooranam
3 grams twice a day for 3 months.
|
|
|
Inclusion Criteria
|
| Age From |
25.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
⮚Age: 25-70 years
⮚Sex: Both male & Female
⮚Weight: 40-100 kgs
⮚Patients of Hypertension having – Grade 1, BP Systolic 140-159 mm Hg and Diastolic 90-99 mm Hg (Patients who have not taken any medicine for more than 30 days or newly diagnosed patients) |
|
| ExclusionCriteria |
| Details |
⮚Secondary Hypertension with any organ damage like retinopathy or renal dysfunction,
⮚H/o. CVD
⮚Orthostatic Hypotension
⮚Hypertension in Pregnancy
⮚Hypertension associated with Stroke, Ischemic heart disease
⮚Drugs (NSAIDS, Oral contraceptive pills)
⮚Alcohol abuse |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
4.7)Outcome measure: BP measurement as per the 2020 International Society of Hypertension guidelines. Then, Lab Investigation before and after treatment.
4.8)Primary outcome: BP – Quantified measurement |
0, 90 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Laboratory parameter (Quantitative / Qualitative data) |
0, 90 days |
|
|
Target Sample Size
|
Total Sample Size="198"
Sample Size from India="198"
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 3 |
|
Date of First Enrollment (India)
|
18/10/2023 |
| 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="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
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
- What data in particular will be shared?
Response (Others) -
- What additional supporting information will be shared?
Response (Others) -
- Who will be able to view these files?
Response (Others) -
- For what types of analyses will this data be available?
Response (Others) -
- By what mechanism will data be made available?
Response (Others) -
- For how long will this data be available start date provided 29-09-2023 and end date provided 30-10-2024?
Response - Beginning 9 months and ending 36 months following article publication.
- Any URL or additional information regarding plan/policy for sharing IPD?
Additional Information - Nil
|
Brief Summary
Modification(s)
|
Venthamarai chooranam(VMC), a polyherbal Siddha medicine was studied in animal model about its potential therapeutic effect on hypertension and found VMC potentially interacts with renin-angiotensin components and endothelial functions, and thereby exerts its antihypertensive action . A Review article - Phytochemical Profile and Biological Activity of Nelumbo nucifera elucidates the various scientific experiments conducted on Nelumbo nucifera . The dissertation research work of Siddha PG scholar also demonstrates the safety and therapeutic effect in animal models . The Siddha Medicine Venthamarai Choornanam is a time-tested medicine and is being prescribed for hypertension patients. It is well tolerated and would provide holistic benefit to the patient. With this background, a clinical research in the form of Randomised Control Trial(RCT) is proposed to determine the thereaputic effect of Venthamarai Choornam on Grade-1 hypertension as measured by 2020 International |