| CTRI Number |
CTRI/2023/05/052604 [Registered on: 12/05/2023] Trial Registered Prospectively |
| Last Modified On: |
08/05/2023 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Comparison of Terbinafine and Itraconazole in patients of tinea cruris |
|
Scientific Title of Study
|
Comparison of oral Terbinafine Vs oral Itraconazole in patients of Tinea Cruris in a tertiary care hospital of North East India- an open level randomized clinical trial |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Bhargabi Kundu |
| Designation |
PGT 1st Year Pharmacology |
| Affiliation |
Agartala Govt Medical College |
| Address |
Department of Pharmacology Agartala Govt. Medical College & GB Pant Hospital Kunjaban
West Tripura
TRIPURA
799006
India |
| Phone |
09774712971 |
| Fax |
|
| Email |
bhargabikundu@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Debasis Ray |
| Designation |
Prof. & Head Pharmacology |
| Affiliation |
Agartala Govt Medical College |
| Address |
Dept. of Pharmacology
Agartala Govt. Medical College and GBP Hospital
Po. Kunjavan
West Tripura
TRIPURA
799006
India |
| Phone |
9436125100 |
| Fax |
|
| Email |
contactdebasisray@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Bhargabi Kundu |
| Designation |
PGT 1ST YEAR PHARMACOLOGY |
| Affiliation |
Agartala Govt Medical College |
| Address |
Department of Pharmacology Agartala Govt. Medical College & GB Pant Hospital Kunjaban
West Tripura
TRIPURA
799006
India |
| Phone |
09774712971 |
| Fax |
|
| Email |
bhargabikundu@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
AGMC GBP Hospital |
| Address |
Agartala Govt. Medical College & GBP Hospital Kunjavan PIN 700996 |
| 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 |
| Bhargabi Kundu |
Agartala Govt Medical College and GBP hospital |
Department of Dermatology
kunjavan Tripura West
Pin 799006
West Tripura
TRIPURA |
9774712971
bhgabikundu@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee for clinical studies |
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, (2) ICD-10 Condition: L00-L99||Diseases of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Itraconazole |
200 mg once daily orally for 14 days |
| Comparator Agent |
Terbinafine |
500 mg once daily orally for 14 days |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
65.00 Year(s) |
| Gender |
Both |
| Details |
ALL NEWLY DIAGNOSED TINEA CRURIS SUBJECTS HAVE NOT RECEIVED ANTIFUNGAL IN LAST 14 DAYS |
|
| ExclusionCriteria |
| Details |
PREGNANT AND LACTATING WOMEN
PATIENTS ON IMMUNOSUPPRESSIVE DRUGS
PATIENTS UNWILLING FOR A REGULAR FOLLOW UP
PATIENTS WITH RELAPSE AND RECURRENT CASES OF TINEA CRURIS |
|
|
Method of Generating Random Sequence
|
Permuted block randomization, variable |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Erythema, Scaling, peripheral spread to other body sites |
After 14 days and 42 days of treatment |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| LFT |
42 DAYS |
|
|
Target Sample Size
|
Total Sample Size="170"
Sample Size from India="140"
Final Enrollment numbers achieved (Total)= "0"
Final Enrollment numbers achieved (India)="170" |
|
Phase of Trial
|
N/A |
|
Date of First Enrollment (India)
|
20/05/2023 |
| Date of Study Completion (India) |
05/09/2024 |
| Date of First Enrollment (Global) |
Date Missing |
| Date of Study Completion (Global) |
Date Missing |
|
Estimated Duration of Trial
|
Years="1"
Months="6"
Days="0" |
|
Recruitment Status of Trial (Global)
|
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)?
Response - NO
|
|
Brief Summary
|
Positive KOH Tinea cruris patients will be randomized and recruited into two groups and oral Terbinafine 500 mg and oral Itraconazole 100 mg will be given for 14 days. The purpose of the study is to compare the safety and efficiency of Terbinafine and Itraconazole. For that purpose LFT will be 0 and 42 days and KOH will be done at 0, 14 and 42 days of treatment. |