| CTRI Number |
CTRI/2019/11/022102 [Registered on: 21/11/2019] Trial Registered Prospectively |
| Last Modified On: |
21/11/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
A clinical trial to study the effect of the drug Athimathura chooranam and Ayilpattai pattru in patients having Venpulli(Vitiligo) |
|
Scientific Title of Study
|
Phase II An open single group non randomized study on "Venpulli"(Vitiligo) to evaluate the official siddha formulation "Athimathura chooranam(Int)& Ayilpattai pattru (Ext) in children of Both sex aging between 5-12 years attending OPD at Anna hospital |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
DrGArthi |
| Designation |
PG Scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate department of kuzhanthai maruthuvam
Government siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai
Chennai
TAMIL NADU
600 106
India |
| Phone |
9597298671 |
| Fax |
|
| Email |
oviya.vaithiyanathan@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DrVRani |
| Designation |
HOD and professor |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate. Department of kuzhanthai maruthuvam, Government siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9442286863 |
| Fax |
|
| Email |
ranimoorthybsms19@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
DrGArthi |
| Designation |
PG scholar |
| Affiliation |
Government siddha medical college |
| Address |
Post graduate
Department of kuzhanthai maruthuvam
Government siddha medical college
6 Anna arch road
NSK nagar
Arumbakkam chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9597298671 |
| Fax |
|
| Email |
oviya.vaithiyanathan@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai 106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
Government siddha medical college
6 Anna arch road
NSK NAGAR
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 |
| DrGArthi |
Arignar Anna hospital of indian medicine |
Room no 25 Siddha department
6 Anna arch road
NSK Nagar
Arumbakkam
Chennai 106
Chennai
TAMIL NADU |
9597298671
oviya.vaithiyanathan@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: L80||Vitiligo, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Athimathura chooranam |
0.5- 1 gm twice a day is given with Luke warm water for 48 days |
| Intervention |
Ayilpattai pattru |
Applying externally on the affected area for 48 days |
| Comparator Agent |
Nil |
Nil |
|
|
Inclusion Criteria
|
| Age From |
5.00 Year(s) |
| Age To |
12.00 Year(s) |
| Gender |
Both |
| Details |
Age 5 - 12 years
Both Male and female children
Hypo pigmented patches surrounded by hyper pigmented border present in any part of the body |
|
| ExclusionCriteria |
| Details |
Age below 4 years
Albinism
Piebaldsim
Depigmented patches occurred after burns
Hypopigmented patches starts firstly in lips,Genital area
Juveline diabetes with vitiligo |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
It is mainly assessed by reduction in VASI score
Photos of the patient before and after treatment for the clinical improvement |
48 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It 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)
|
22/11/2019 |
| 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)?
|
|
Brief Summary
|
This is an phase II open single group non randomized study to evaluate the official siddha formulation Athimathura chooranam(Int)& Ayilpattai pattru (Ext) for venpulli (Vitiligo).The trial drug is given 0.5 - 1 gm twice a day for 48 days & Ayilpattai pattru externally for 48 days .Clinical trial conducted after conducting preclinical toxicity study. The trial drug Athimathura chooranam and Ayilpattai pattru is mentioned in Gunapadam Mooligai.During the trial ,study related data will be recorded and documented. After the completion of trial all the data will be analysed statistically |