| CTRI Number |
CTRI/2024/07/071212 [Registered on: 24/07/2024] Trial Registered Prospectively |
| Last Modified On: |
09/07/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
clinical study using siddha medicine for Atopic dermatitis |
|
Scientific Title of Study
|
Phase II Non-randomized clinical study on Bala Karappan(Atopic Dermatitis) with the evaluation of siddha trial drug Yazhpanathennai(internal)and Nathaisoori ennai(external)in children. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr D Indrabala |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai |
| Address |
Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9677752406 |
| Fax |
|
| Email |
indrabaladhanuskodi99@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr C Shanmuga Priya |
| Designation |
Assistant Professor |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai |
| Address |
Room No 25 Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9445661808 |
| Fax |
|
| Email |
cspriya2004@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr D Indrabala |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College Arumbakkam Chennai |
| Address |
Room No 25
Department of Kuzhanthai Maruthuvam
Government Siddha Medical College Arumbakkam Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9677752406 |
| Fax |
|
| Email |
indrabaladhanuskodi99@gmail.com |
|
|
Source of Monetary or Material Support
|
| Arignar Anna Government Siddha Medical College,No-6 Anna Arch Road,Arumbakkam,Chennai,600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College |
| Address |
No 6 Anna Arch Road NSK Nagar Arumbakkam Chennai 600106 |
| 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 D Indrabala |
Government siddha medical college |
Room No,25,Department of Kuzhanthai Maruthuvam
Aringar Anna Government Hospital
NSK nagar Arumbakkam
Chennai
TAMIL NADU |
9677752406
indrabaladhanuskodi99@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee,Arumbakkam,Chennai-106e,Arumbakkam,Chennai-106e |
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 |
| Comparator Agent |
NIL |
NIL |
| Intervention |
Yazhpanathennai (internal)Nathaisoori Ennai(external) |
Yazhpanathennai 4ml once a day for 10 days and external application of Nathaisoori Ennai on affected area. |
|
|
Inclusion Criteria
|
| Age From |
3.00 Year(s) |
| Age To |
7.00 Year(s) |
| Gender |
Both |
| Details |
Itching
Erythema
Papules
Vesicles
Oozing
Crusting
Scaling
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 |
10 Days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| It is assessed by comparing the safety parameters before and after treatment |
10 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)
|
03/10/2024 |
| 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
|
N/A |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
This is a single Non-Randomized open clinical trial to study the safety and efficacy of siddha trial drug Yazhpanathennai (internal) is to be given 4 ml once a day for 10 days and External application of Nathaisoori Ennai on the affected area.Clinical trial conducted after conducting pre clinical study. The trial drug Yazhpanathennai has mentioned in Koshayi anuboga vaidya bramma ragasiyam,part-2 and External application of Nathaisoori Ennai has mentioned in Sarapendra vaithya muraigal. During the trial study related data will be recorded and documented. After the completion of the trial all data will be statistically analysed. |