| CTRI Number |
CTRI/2022/02/040005 [Registered on: 03/02/2022] Trial Registered Prospectively |
| Last Modified On: |
02/02/2022 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Other |
|
Public Title of Study
|
Siddha drug veppampoo Mathirai for Blood pressure |
|
Scientific Title of Study
|
Preclinical and clinical evaluation of Siddha drug Veppampoo Mathirai in uraththa pitha vaatham - Systemic Hypertension |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr S M Chitra |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical College Arumbakkam chennai 106 |
| Address |
Government siddha medical College Arumbakkam chennai 106
F 3 D Vgn imperia phase 1 VGN Mahalakshmi Nagar Thiruverkadu Chennai 77
Chennai
TAMIL NADU
600106
India |
| Phone |
09444177230 |
| Fax |
|
| Email |
chittu758@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr N Anbu |
| Designation |
Professor |
| Affiliation |
Government siddha medical College Arumbakkam chennai 106 |
| Address |
Government siddha medical College Arumbakkam chennai 106
Government siddha medical College Arumbakkam chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9443279412 |
| Fax |
|
| Email |
nanbu.sumi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr S M Chitra |
| Designation |
Lecturer |
| Affiliation |
Government siddha medical College Arumbakkam chennai 106 |
| Address |
Government siddha medical College Arumbakkam chennai 106
Government siddha medical College Arumbakkam chennai 106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444177230 |
| Fax |
|
| Email |
chittu758@gmail.com |
|
|
Source of Monetary or Material Support
|
| Aringnar Anna Government hospital for Indian Medicine |
|
|
Primary Sponsor
|
| Name |
Self |
| Address |
Government siddha medical College Arumbakkam chennai 106 |
| Type of Sponsor |
Government medical college |
|
|
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 |
| S M Chitra |
Aringnar Anna Government hospital of Indian medicine |
Aringnar Anna Government hospital campus Arumbakkam chennai 106
Chennai
TAMIL NADU |
09444177230
chittu758@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Instituitional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I00-I99||Diseases of the circulatory system, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Nil |
Nil |
| Intervention |
Veppampoo mathirai |
500gm 2 tablets twice daily with lukewarm water for 60 days. |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Newly diagnosed systemic Hypertension patients having blood pressure value systolic 140-179mmHg and diastolic 90-109mmHg, willing to give written consent to participate in the study |
|
| ExclusionCriteria |
| Details |
Blood pressure value having systolic greater or equal to 180mmHg and diastolic greater or equal to 110mmHg, Secondary hypertension, Diabetes mellitus, cardiovascular disease/ hepatic disease, asthmatic and copd patients, pregnant women and lactating mothers, patients who are on steroids, oral contraceptive pills, oestrogen replacement therapy.participants will be excluded clinically or based on available medical reports. |
|
|
Method of Generating Random Sequence
|
|
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome assessed by an expected reduction in blood pressure value of systolic 10-20mmHg and diastolic 5-15mmHg. |
0 day and 61 day |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Liver and renal parameters compared before and after treatment. |
0 day and 61 day |
|
|
Target Sample Size
|
Total Sample Size="31"
Sample Size from India="31"
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)
|
10/02/2022 |
| 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 Yet Recruiting |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
Not published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is an open clinical interventional evaluation of Siddha drug Veppampoo Mathirai for Systemic Hypertension. Both gender of age 18-60 will be enrolled based on inclusion and exclusion criteria. Intervention will be given for 60 days and the outcome is assessed on the basis of systolic, diastolic and mean arterial pressure before and after treatment. |