| CTRI Number |
CTRI/2024/05/068133 [Registered on: 31/05/2024] Trial Registered Prospectively |
| Last Modified On: |
25/05/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Siddha |
| Study Design |
Non-randomized, Multiple Arm Trial |
|
Public Title of Study
|
Efficacy of Siddha Medicine Irunelli Karpam and Kanthaga Thailam in Tinea Corporis |
|
Scientific Title of Study
|
An Open Clinical Trial To Explore Therapeutic Efficacy Of Irunelli Karpam (Internal) And Kanthaga Thailam (External) In Tinea Corporis Among Patients Attending OPD At Government Siddha Medical College Hospital Chennai, A Pilot Study |
| 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 R Saranya |
| Designation |
PG Scholar |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
6380712060 |
| Fax |
|
| Email |
saranya101rks@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr V Isabell rafeeda |
| Designation |
Lecturer, Department of UG Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam, Chennai
Chennai
TAMIL NADU
600106
India |
| Phone |
9444459047 |
| Fax |
|
| Email |
vrafeeda@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Isabell rafeeda |
| Designation |
Lecturer, Department of UG Pothu Maruthuvam |
| Affiliation |
Government Siddha Medical College, Arumbakkam, Chennai |
| Address |
Department of Pothu Maruthuvam, Government Siddha Medical College, Arumbakkam
Chennai
TAMIL NADU
600106
India |
| Phone |
9444459047 |
| Fax |
|
| Email |
vrafeeda@yahoo.com |
|
|
Source of Monetary or Material Support
|
| Government Siddha Medical College, Arumbakkam, Chennai -600106 |
|
|
Primary Sponsor
|
| Name |
Government Siddha Medical College, Chennai |
| Address |
No.6,Anna Arch Road, 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 R Saranya |
Government Siddha Medical College Hospital, Chennai |
Department of Pothu Maruthuvam, Room no.S1, Government Siddha Medical College Hospital, Arumbakkam
Chennai
TAMIL NADU |
6380712060
saranya101rks@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, GSMC, Chennai |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Irunelli Karpam
(Internal) |
Dose:200 mg with ghee, Twice a day,for 1 month
Route of administration: Oral
Group B will receive only internal medicine named Irunelli Karpam |
| Intervention |
Irunelli Karpam (Internal) and Kanthaga Thailam (External) |
Irunelli Karpam Dose: 200 mg with ghee, Twice a day
Route of administration: Oral
Total duration of intervention: 1 month
Kanthaga thailam will be applied over lesion
Group A will receive both internal and external treatment. |
| Comparator Agent |
Kanthaga Thailam (External) |
Kanthaga Thailam will be applied over the lesion for 1 month
Group C will receive external treatment named Kanthaga Thailam |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients seeking treatment for tinea corporis
Patients who are having classical symptoms of single or multiple scaly annular lesions
with slightly raised, erythematous edge with central clearing in body.
Patients will be eligible if they had a Lesion Severity Score of atleast 5 |
|
| ExclusionCriteria |
| Details |
Age below 18 years
, Pregnant and lactating mothers, Patients allergic to Sulphur
, Presence of any other Skin diseases that may affect outcomes of study like
Contact Dermatitis, Nummular eczema
, Plaque psoriasis |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To evaluate the efficacy of Siddha Medicine Irunelli Karpam(Internal) and Kanthaga thailam (External) in treating Tinea corporis patients using Lesion severity Score and photographs will be enclosed before and after treatment |
1 month |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Assess alleviation in clinical signs and symptoms after
the treatment and assessing the improvement of the patient from severe to moderate, moderate to
mild through Lesion Severity Score which helps to ensure the wellness of the patient. |
1 month |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
Final Enrollment numbers achieved (Total)= "30"
Final Enrollment numbers achieved (India)="30" |
|
Phase of Trial
|
Phase 2 |
|
Date of First Enrollment (India)
|
10/06/2024 |
| Date of Study Completion (India) |
23/11/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="0"
Months="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Completed |
|
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
|
Dermatophytosis is a fungal infection in the skin’s stratum corneum layer caused by species of three genera: Trichophyton, Microsporum, and Epidermophyton, and affecting 20–25% of the world population with varying geographic distribution. Tinea corporis is amost prominent infection in India (32.4%), Tinea corporis is a superficial dermatophyte infection of cornified layers of skin typically appears as a single lesion or multiple scaly annular lesions with a slightly raised, erythematous edge with central clearing on the trunk, extremities and face. So, it is considered to evaluate the efficacy of Siddha Medicine Irunelli Karpam (Internal) and Kanthaga thailam (External) in treating Tinea corporis. The study is designed to assess the improvement of the patient from severe to moderate, moderate to mild through Lesion Severity Score. |