| CTRI Number |
CTRI/2022/11/047404 [Registered on: 17/11/2022] Trial Registered Prospectively |
| Last Modified On: |
17/11/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Karappan thailam (internal) and nunapattai thailam(external) for karappan(Atopic dermatitis) for children |
|
Scientific Title of Study
|
PHASE II NON RANDOMIZED CLINICAL STUDY ON BALAKARAPPAN (ATOPIC DERMATITIS) WITH THE EVALUATION OF SIDDHA TRIAL DRUG KARAPPAN ENNAI(INTERNAL) AND NUNAPATTAI THAILAM (EXTERNAL) IN CHILDREN |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr M RAHUL |
| Designation |
Pg scholar |
| Affiliation |
GOVERNMENT SIDDHA MEDICAL COLLEGE,CHENNAI |
| Address |
ROOM NO 25,DEPARTMENT OF PG KUZHANTHAI MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM
Chennai
TAMIL NADU
600106
India |
| Phone |
7010819169 |
| Fax |
|
| Email |
rahulmathan20@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Shanmugapriya |
| Designation |
Lecturer |
| Affiliation |
Government Siddha medical college arumbakkam |
| Address |
ROOM NO 25,DEPARTMENT OF PG KUZHANTHAI MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM
Chennai
TAMIL NADU
600106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr M RAHUL |
| Designation |
Pg scholar |
| Affiliation |
Government siddha medical college |
| Address |
ROOM NO 25,DEPARTMENT OF PG KUZHANTHAI MARUTHUVAM,GOVERNMENT SIDDHA MEDICAL COLLEGE,ARUMBAKKAM
Chennai
TAMIL NADU
600106
India |
| Phone |
7010819169 |
| Fax |
|
| Email |
rahulmathan20@gmail.com |
|
|
Source of Monetary or Material Support
|
| Government siddha medical college,chennai-106 |
|
|
Primary Sponsor
|
| Name |
Government siddha medical college |
| Address |
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 |
| MRAHUL |
Government siddha medical college and hospital |
Room no 25,Department of PG kuzhanthai maruthuvam,arumbakkam,chennai-106
Chennai
TAMIL NADU |
7010819169
rahulmathan20@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Commitee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L209||Atopic dermatitis, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Karappan ennai(Internal)
Nunapattai thailam(External) |
Karappan ennai(internal)-5ml Od
duration-21 days.
Nunapattai thailam- External application,duration-21 days. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Itching,erythema,papules,vesicles,oozing,crusting,
scaling and lichenification |
|
| ExclusionCriteria |
| Details |
Psoriasis,scabies,photo dermatitis,ichthyosis vulgaris,pityriasis alba |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
Reduction in EASI score(Eczema area severity index)
Reduction in clinical symptoms like itching,papules ,pustules ,oozing,scaling,lichenification
Photos of the patient before and after treatment for the evidence of clinical improvement |
21 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is assessed by comparing the safety parameters before and after treatment. |
21 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)
|
21/11/2022 |
| 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
|
Not yet |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is interventional study in which 40 patients will be selected based on inclusion and exclusion criteria . For internal karappan ennai and for external nunapattai thailam will be given in the dosage of 5 ml OD for internal and the external application of nunapattai thailam opn the affected area for 21 days of duration .The data related to the study will be collected from each patients depends on the reduction of symptoms and changes in the investigations .All collected data will be entered in to MS Excel software . STATA software will be used to perform statistical analysis. |