| CTRI Number |
CTRI/2018/04/013523 [Registered on: 27/04/2018] Trial Registered Retrospectively |
| Last Modified On: |
12/04/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the drug of senkaluneer chooranam on vatha piththam |
|
Scientific Title of Study
|
A prospective open labeled randomized clinical trial on VATHA PITHTHAM primary systemic hypertension with evaluation of trial drug SENKALUNEER CHOORANAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Vettivel Jegatheeswaran |
| Designation |
Post Graduate Student |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
PG Scholar Third Year
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
9894468423 |
| Fax |
04622582010 |
| Email |
jegatheeswaran79@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR A MANOHARAN MD Siddha |
| Designation |
Professor & Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DR A MANOHARAN MD Siddha |
| Designation |
Professor & Head of the Department |
| Affiliation |
Government Siddha Medical College and Hospital |
| Address |
Department of Pothu Maruthuvam
Government Siddha Medical College and Hospital Palayamkottai
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9443886700 |
| Fax |
04622582010 |
| Email |
drmanoharan25@gmail.com |
|
|
Source of Monetary or Material Support
|
| Material Suppot Governemnt Siddha Medical College and Hospital Palayamkottai Tirunelveli |
| OPD and IPD Government Siddha Medical College and Hospital Palayamkottai Tirunelveli |
|
|
Primary Sponsor
|
| Name |
Prof Dr S Neelavathi |
| Address |
Principal
Government Siddha Medical College and Hospital
Palayamkottai 627 002
Tirunelveli
Tamil Nadu
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 |
| DR VETTIVEL JEGATHEESWARAN |
Government Siddha Medical College and Hospital |
OPD Room Number - 10 and IPD
PG Pohtu Maruthuvam
Government Siddha MEdical College and Hospital
Palayamkottai 627 002
Tirunelveli
TAMIL NADU |
9894468423
04622582010
jegatheeswaran79@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Siddha Medical College and Hospital Palayamkottai Tirunelveli |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
VATHA PITHTHAM
PRIMARY SYSTEMIC HYPERTENSION DISEASE, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
SENKALUNEER CHOORANAM |
1000mg Three times per Day for 30 Days |
|
|
Inclusion Criteria
|
| Age From |
30.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patient with Symtoms Headache
Giddiness
Palpitation
Dizziness
Dyspnoea
Shortness of Breath
Fatigue
Blood Pressure
Systolic 140 - 159 mmHg
Diastolic 90 - 99 mmHg
|
|
| ExclusionCriteria |
| Details |
Secondary Hypertension
High Risk Pregnancy
Hypertension Associated
Cerebro Vascular Accident
Ischemic Heart Disease
Chronic Alcoholism
Chronic Liver Disease
Chronic Renal Disease
Endocrine Disorder |
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Other |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Therapeutic Efficacy of KALUNEER CHOORANAM in the Treatment of VATHA PITHTHAM |
30 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To Evaluate the Siddha Cofactor Towords the Efficacy of the Trial Drug SENKALUNEER CHOORANAM and to Evaluate the Pharmacological Action |
30 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)
|
27/06/2017 |
| 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) |
Open to Recruitment |
|
Publication Details
|
No publication |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
The Study is Prospective Open Labeled Randomized Phase II Clinical Trial to Evaluate the Therapeutic Efficacy of Trail Drug SENKALUNEER CHOORANAM 800mg 1000mg tds for 30 days on the 40 Patients with VATHA PITHTHAM that will be conducted in Government Siddha Medical College and Hospital Palayamkottai The Primary Out come Therapeutic efficacy of SENKALUNEER CHOORANAM The Sencondary will be the Evaluation of Siddha Diagnostic Parameters |