| CTRI Number |
CTRI/2019/02/017577 [Registered on: 11/02/2019] Trial Registered Prospectively |
| Last Modified On: |
08/02/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
THE CLINICAL TRIAL TO STUDY THE EFFECT OF THE DRUG RATHA AZHUTHA NIVARANI CHOORANAM IN PATIENTS HAVING HIGH BLOOD PRESSURE |
|
Scientific Title of Study
|
EVALUATION OF RATHA AZHUTHA NIVARANI CHOORANAM FOR URATHA PITHAVATHAM(HYPERTENSION)-AN OPEN CLINICAL STUDY |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DR THAMIL OVIAM R |
| Designation |
PG SCHOLAR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEAGE ARUMBAKKAM CHENNAI |
| Address |
Department of general medicine
Government siddha medical College
6, Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7200665114 |
| Fax |
|
| Email |
ovimithran@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR KANAKAVALLI K |
| Designation |
PROFESSOR |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI |
| Address |
Department of general medicine
Government siddha medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444122865 |
| Fax |
|
| Email |
drkkanakavalli@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Thamiloviam |
| Designation |
Pg scholar |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE ARUMBAKKAM CHENNAI |
| Address |
Department of general medicine
Government siddha medical College
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Tamilnadu
India
600106
Chennai
TAMIL NADU
600106
India |
| Phone |
7200665114 |
| Fax |
|
| Email |
ovimithran@gmail.com |
|
|
Source of Monetary or Material Support
|
| GOVERNMENT SIDDHA MEDICAL COLLEAGE ARUMBAKKAM CHENNAI TAMIL NADU |
|
|
Primary Sponsor
|
| Name |
GOVERNMENT SIDDHA MEDICAL COLLEGE |
| Address |
NO 6 ANNA ARCH ROAD NSK NAGAR ARUMBAKKAM CHENNAI TAMIL NADU |
| 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 |
| DR THAMIL OVIAM R |
Arignar Anna Government Hospital for Indian Medicine |
Room No: 2
Siddha Department
Arignar Anna Government hospital for Indian Medicine
6 Anna Arch Road
NSK Nagar
Arumbakkam
Chennai
Tamil Nadu
India
600106
Chennai
TAMIL NADU |
7200665114
ovimithran@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: I10-I16||Hypertensive diseases, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
NIL |
NIL |
| Intervention |
RATHA AZHUTHA NIVARANI CHOORANAM |
RATHA AZHUTHA NIVARANI CHOORANAM IS ADMINISTRATTED ORALLY AT THE DOSE OF 1gm TWICE A DAY ALONG WITH HONEY FOR 48 DAYS |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
BLOOD PRESSURE LEVEL ABOVE 140/90mmHg AND BELOW 180/100mmHg
FATIGUE
HEADACHE
NAUSEA
GIDDINESS
SWEATING
OBESITY |
|
| ExclusionCriteria |
| Details |
BLOOD PRESSURE LEVEL ABOVE 180/100mmHg
HYPERTENSION IN PREGNANCY
ASSOCIATED OTHER SECONDARY DISEASES LIKE RENAL FAILURE CCF
OTHER CARDIAC PROBLEMS
CHRONIC DISEASES
HORMONAL DISORDERS
DIABETES MELLITUS |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Outcome is mainly assessed by decrease in BP to optimum level |
Outcome is mainly assessed by decrease in BP to optimum level |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| NIL |
NIL |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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)
|
13/02/2019 |
| 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
|
NOT YET |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
THIS IS SINGLE NON-RANDOMIZED OPEN CLINICAL TRIAL TO STUDY THE SAFETY AND EFFICACY OF SIDDHA TRIAL DRUG RATHA AZHUTHA NIVARANI CHOORANAM. THE TRIAL DRUG IS GIVEN 1gm TWICE A DAY ALONG WITH HONEY AS A ADJUVENT FOR 48 DAYS.CLINICAL TRIAL IS CONDUCTED AFTER CONDUCTING PRECLINICAL TOXICITY STUDY.THE TRIAL DRUG RATHA AZHUTHA NIVARANI CHOORANAM IS MENTIONED IN THE PHARMACOPOEIA OF SIDDHA RESEARCH MEDICINES. DURING THE TRIAL ALL THE STUDY RELATED DATA WILL BE RECORDED AND DOCUMENTED. AFTER THE COMPLETION OF TRIAL ALL THE DATA WILL BE ANALYSED STATISTICALLY. |