| CTRI Number |
CTRI/2019/07/020042 [Registered on: 05/07/2019] Trial Registered Prospectively |
| Last Modified On: |
23/06/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Clinical evaluation of the effect on oral administration of tarÄ mÄttirai in management of Vitiligo |
|
Scientific Title of Study
|
Clinical evaluation of the effect on oral administration of tarÄ mÄttirai in management of VENKUTTAM |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
L Santhosh kumar |
| Designation |
Post graduate student |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai. |
| Address |
Department Of Kuzhanthai Maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU
627 002
India |
| Phone |
8883447447 |
| Fax |
|
| Email |
drsanthosh94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
K Shyamala |
| Designation |
Lecturer Grade-II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai. |
| Address |
Department Of Kuzhanthai Maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
K Shyamala |
| Designation |
Lecturer Grade-II |
| Affiliation |
Government Siddha Medical College and Hospital,Palayamkottai. |
| Address |
Department Of Kuzhanthai Maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli
Tirunelveli
TAMIL NADU
627002
India |
| Phone |
9442277124 |
| Fax |
|
| Email |
shyamsujisathya@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college and hospital, palayamkottai, Tirunelveli,
Tamil Nadu - 627002 |
|
|
Primary Sponsor
|
| Name |
Santhoshkumar L |
| Address |
Department Of Kuzhanthai Maruthuvam,
Government siddha medical college and hospital,
Palayamkottai.
Tirunelveli-627002 |
| Type of Sponsor |
Other [Self] |
|
|
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 |
| L Santhosh Kumar |
Government Siddha Medical College and Hospital,Palayamkottai Tirunelveli-627002 |
Op no 7
Department of kuzhanthai maruthuvam
Government siddha medical college and hospital, Palayamkottai, Tirunelveli
Tirunelveli
TAMIL NADU |
8883447447
drsanthosh94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee Government Siddha Medical College, Palayamkottai, Tirunelveli-627002, Tamil Nadu, India |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
nil |
nil |
| Intervention |
tarÄ mÄttirai |
The test drug will be administered orally and externally.
internal dose - thettrankottai alavu(Strycnus potatorum) 1/2 - 1 tablet two times a day with an adjuvant of sufficient water |
|
|
Inclusion Criteria
|
| Age From |
4.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
The patient attending to the OPD will be screened for the following symptoms and will be included in the study
Primary symptoms
1. Hypopigmented patches with hyperpigmented border without any structural changes in any part of the body surface.
2. Children who are willing to undergo blood tests for laboratory investigations |
|
| ExclusionCriteria |
| Details |
Tinea versicolor
Chemical leucoderma
Dermatological manifestation of leprosy
Burn scar
Pityriasis alba
Total albinism
White patches in mucous membrane |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Reduction of the hypopigmented lesions over the affected area |
45 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in the reccurence rate of the lesions |
3 months |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
06/07/2019 |
| Date of Study Completion (India) |
24/03/2020 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="2"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
Publication Details
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
Brief Summary
Modification(s)
|
It is an interventional study, to evaluate the effect of oral administration of tarÄ mÄttirai in management of venkuttam consisting of the sample size of 40. The patient were assessed on the basis of clinical symptoms like Hypo-pigmented patches with hyper-pigmented border without any structural changes in any part of the body surface, and the primary outcome were assessed after 45 days of test drug administraion and the secondary outcome were followed up after every 3 months. |