| CTRI Number |
CTRI/2018/02/012097 [Registered on: 22/02/2018] Trial Registered Retrospectively |
| Last Modified On: |
22/02/2018 |
| 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 to study the effect of trial drug Vishnu Chakra Mathirai (Internal),Kodiveli Thylam (External)on Pakkavatham(Hemiplegia) |
|
Scientific Title of Study
|
An Open Clinical Study to evaluate the clinical efficacy of siddha sasthric formulation "Vishnu Chakra Mathirai"(Internal)"Kodiveli Thylam "(External) for the treatment of Pakkavatham(Hemiplegia) |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr R Kirubakaran |
| Designation |
pg student |
| Affiliation |
government siddha medical college and hospital |
| Address |
Department of pg sirappu maruthuvam
government siddha medical college
palayamkottai
tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drkirubakaran1@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr A S Poongodi kanthimathi |
| Designation |
Head of the Department |
| Affiliation |
government siddha medical college and hospital |
| Address |
Department of pg sirappu maruthuvam
Sirappu maruthuvam department
government siddha medical college
palayamkottai
tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
arunapriya1995@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Kirubakaran |
| Designation |
pg scholar |
| Affiliation |
Government siddha medical college |
| Address |
Department of pg sirappu maruthuvam. government siddha medical college.palayamkottai.tirunelveli.
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
|
| Fax |
|
| Email |
drkirubakaran1@gmail.com |
|
|
Source of Monetary or Material Support
|
| OPD and IPD of government siddha medical college and hospital.
library of government siddha medical college and hospital |
|
|
Primary Sponsor
|
| Name |
Dr S Neelavathi |
| Address |
Principal
Government siddha medical college and hospital palayamkottai
Tirunelveli |
| 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 R Kirubakaran |
Government siddha medical college and hospital |
OP NO 4
Pg sirappu maruthuvam department
Tirunelveli
TAMIL NADU |
9597250752
drkirubakaran1@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 |
inability or difficulty to use lt or rt upper limp and lower limp
difficulty in speech
deviation of ankle of mouth, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Not applicable |
Not applicable |
| Intervention |
Vishnuchakra mathirai130mg twice a day with thirikadugu choornam and inji juice and honey(Interal)
Kodiveli thylam 30 ml Thylam (External) |
130mg twice a day with thirikadugu choornam and inji juice and honey(Internal)
30 ml Thylam (External) |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.willing for admission and study in IPD for 40 days or willing to attend OPD.
2.Inability/difficulty to use upper/lower limb of one side.
3.willing to sign in the informed consent form |
|
| ExclusionCriteria |
| Details |
1.Age:Below 15 and above 60
2.Pregnant and lactating women
3.known h/o hypersensitivity or allergy to drug ingredients
4.Renal failure
5.Cirrhosis of liver
6.Cardiac diseases |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
On-site computer system |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Ability to perform day to day activities well. |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Evaluation of siddha diagnostic parameter |
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)
|
05/09/2017 |
| 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="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
none yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Phase II criteria based clinical study to evaluate the clinical efficacy of siddha herbo mineral formulation on Vishnuchakra mathirai 130mg twice a day with thirikadugu choornam +inji juice &honey (Internal) for 48 days and Kodiveli thylam 30 ml (External) for 48 days in the treatment of pakkavatham(Hemiplegia) during the trail period of one year six months that will be conducted in government siddha medical college and hospital , palayamkottai , tirunelveli , tamilnadu . the primary outcome will be the ability to perform day to day activities of well trail drug (Vishnu chakra mathirai) on pakkavatham .the secondary outcome will be the evaluation of siddha diagnostic parameters . |