| CTRI Number |
CTRI/2021/11/037810 [Registered on: 03/11/2021] Trial Registered Prospectively |
| Last Modified On: |
29/10/2021 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Biological
Siddha
Other (Specify) |
| Study Design |
Non-randomized, Active Controlled Trial |
|
Public Title of Study
|
Clinical evaluation of Siddha medicine elathi chooranam for the management of hypertension |
|
Scientific Title of Study
|
Phase II non randomized open clinical evaluation of Siddha medicine elathi chooranam for the management of Uratha pitha vatham (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 Dinesh kumar |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Post graduate Department of general medicine Government Siddha Medical College, Arumbakkam, Chennai Tamilnadu 600106 India
Post graduate Department of general medicine Government Siddha Medical College, Arumbakkam, Chennai Tamilnadu 600106 India
Chennai
TAMIL NADU
600106
India |
| Phone |
6379266336 |
| Fax |
|
| Email |
gulludinesh1995@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrRSasirekha |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical College |
| Address |
Department of pothu maruthuvam Government Siddha Medical College, Arumbakkam, Chennai 600106
Department of pothu maruthuvam Government Siddha Medical College, Arumbakkam, Chennai 600106
Chennai
TAMIL NADU
600106
India |
| Phone |
9444832728 |
| Fax |
|
| Email |
sasirekha.siddha@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
SDinesh kumar |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College |
| Address |
Second year PG Scholar, Department of pothu maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai-106
Second year PG Scholar, Department of pothu maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai-106
Chennai
TAMIL NADU
600106
India |
| Phone |
6379266336 |
| Fax |
|
| Email |
gulludinesh1995@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College Arumbakkam Chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| 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 |
| SDinesh kumar |
Arignar Anna Hospital of Indian Medicine and Homoeopathy |
Room no S-1, Department of pothu maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai-106
Chennai
TAMIL NADU |
6379266336
gulludinesh1995@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||Essential (primary) hypertension, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
ELATHI CHOORANAM |
5gms of ELATHI CHOORANAM is administered twice a day with honey for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Primary hypertension
Giddiness
Sweating
Nausea
Headache
Fatigue
Blood pressure level140/90mmhg |
|
| ExclusionCriteria |
| Details |
Secondary hypertension
Hypertension in pregnancy
Hypertension with diabetes mellitus
Blood pressure above 180/100 |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Primary outcome is mainly assessed by reducing blood pressure up to 10-20 mmHg systolic and 5-10 mmhg in diastolic level |
48days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Secondary outcome is assessed by comparing the safety parameters before and after treatment |
48 days |
|
|
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)
|
11/11/2021 |
| 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)?
Response - NO
|
|
Brief Summary
|
This is single Non randomized open clinical trial to study the safety and efficacy of siddha trial drug ELATHI CHOORANAM. The trial drug is given 5grams twice a day for 48 days. Clinical trial is conducted after conducting pre clinical toxicity study. The trial drug ELATHI CHOORANAM is mentioned in sarabenthira vaithiya muraikal. During the trial all the study related data will be recorded and documented. After the completion of the trial all the data will be analysed statistically |