| CTRI Number |
CTRI/2022/03/040776 [Registered on: 03/03/2022] Trial Registered Prospectively |
| Last Modified On: |
01/03/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial on SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (SYSTEMIC HYPERTENSION) |
|
Scientific Title of Study
|
A Prospective Open labelled non Randomized phase II clinical trial on SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (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 |
SIVALATHAJINI SIVATHEEPAN |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college and hospital |
| Address |
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
sivalatha088@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrSUmakalyani MDs |
| Designation |
Lecturer |
| Affiliation |
Government Siddha Medical college and hospital. |
| Address |
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
8072685509 |
| Fax |
|
| Email |
sukgsmc2014@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Prof DrAManoharan MDs PhD |
| Designation |
Professor |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Government Siddha Medical College and Hospital Palayamkottai Tirunelveli Tamilnadu India
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
|
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Opd and Ipd department of Government Siddha Medical College and Hospital |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college and hospital |
| Address |
Government siddha medical college and hospital Palayamkottai Tirunelveli Tamilnadu India |
| 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 |
| Sivatheepan Sivalathajini |
Government Siddha Medical College and Hospital |
PG department of Pothu Maruthuvam, OP no 10, Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli-627002, Tamilnadu.
Tirunelveli
TAMIL NADU |
9659690865
sivalatha088@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical 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 |
| Comparator Agent |
Nil |
0 |
| Intervention |
Saaranai chooranam |
20milligram/body weight twice a day with ghee/jaggery for 45 days |
|
|
Inclusion Criteria
|
| Age From |
35.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
1.Patient presenting with the conditions such as known systemic hypertension - Stage II (≥140/ ≥90 mm/hg), AHA, Hyperlipidemia, Diabetic mellitus - Type II, Choronic alcoholism, Smoking. |
|
| ExclusionCriteria |
| Details |
1.Age group below 34 years and above 71 years.
2.Patients presenting with the following conditions, such as Known malignant Hypertension, Ischaemic heart disease, Chronic kidney disease, Chronic liver disease, Pregnancy, Lactating mother. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| The outcome will be aimed at reducing the systemic hypertension. If during or after treatment systolic blood pressure below or equal to 130mmHg and diastolic blood pressure below or equal to 90mmHg it will be considered as successful outcome. |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1.To evaluate the pharmacological activities of trial drug.
2.Study about the prevalance of Raththa kothippu (Systemic Hypertension) in relation between diet and life style.
3.To evaluate safety profile for acute and sub acute toxicity of trail drug.
4.To perform biochemical analysis.
|
45 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)
|
11/03/2022 |
| 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 Applicable |
| Recruitment Status of Trial (India) |
Not Yet Recruiting |
|
Publication Details
|
NIL |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
The study is a prospective open labelled phase II non-randomized clinical trial to evaluate the therapeutic efficacy of SAARANAI CHOORANAM in the management of RATHTHA KOTHIPPU (SYSTEMIC HYPERTENSION). The trial drug will be administered orally at the dose of 20mg/Kg/BW/Twice a day20mg/Kg/BW/Twice a day for 45 days along with Ghee / Jaggery as adjuvant in 40 patients. The trial period of 12 months will be carried out in Government Siddha Medical College and Hospital, Palayamkottai, Tirunelveli, Tamilnadu. The primary outcome will be the evaluation of therapeutic efficacy of trial drug SAARANAI CHOORANAM. The secondary outcome will be the evaluation of Siddha diagnostic parameters, aseessment of safety profile of trial drug, assessment of pharmacological and biochemical parameters of trial drug. In case of any adverse events (AE) is noticed and it will be referred to pharmacovigilance department of SCRI. Further management of patients will be given in OPD facility. |