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CTRI Number  CTRI/2023/10/058844 [Registered on: 18/10/2023] Trial Registered Prospectively
Last Modified On: 17/10/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   A comparative study between oral itraconazole and terbinafine in tinea infection  
Scientific Title of Study   A comparative study of effect of oral itraconazole and terbinafine in tinea infection with species identification of dermatophtyes isolated from superficial fungal infections at tertiary care centre 
Trial Acronym  nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Ankita Narola 
Designation  PG resident 
Affiliation  Mahatma Gandhi Hospital 
Address  Department of Dermatology
Mahatma Gandhi Hospital
Jaipur
RAJASTHAN
302022
India 
Phone  9909121207  
Fax    
Email  ankitanarola1@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Sankalp Awasthi 
Designation  Professor 
Affiliation  Mahatma Gandhi Hospital 
Address  Department of Dermatology, Mahatma Gandhi hospital,Jaipur
Ricco industrial area, Sitapura, Jaipur
Jaipur
RAJASTHAN
302022
India 
Phone  9411865323  
Fax    
Email  dr.sankalp.avasthi@gmail.com  
 
Details of Contact Person
Public Query  
Name  Ankita Narola 
Designation  PG resident 
Affiliation  Mahatma Gandhi Hospital 
Address  Depatment of Dermatology, Mahatma Gandhi hospital, Sitapura,Jaipur

Jaipur
RAJASTHAN
302022
India 
Phone  9909121207  
Fax    
Email  ankitanarola1@gmail.com  
 
Source of Monetary or Material Support  
Mahatma Gandhi Medical College and Hospital, Jaipur, Rajasthan 
 
Primary Sponsor  
Name  Mahatma Gandhi Hospital 
Address  Ricco industrial area, Sitapura, Jaipur 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
Countries of Recruitment     India  
Sites of Study  
No of Sites = 1  
Name of Principal Investigator  Name of Site  Site Address  Phone/Fax/Email 
Ankita Narola  Mahatma Gandhi Hospital  Department of Dermatology
Jaipur
RAJASTHAN 		 9909121207

ankitanarola1@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
IEC of Biomedical and Health Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  comparative study between oral itraconazole and terbinafine in tinea infection  oral itracoanzole 200mg will be given once a day for 6 weeks  
Intervention  comparative study between oral itraconazole and terbinafine in tinea infection  oral itraconazole 130mg SB will be given a day for 6 weeks 
Intervention  comparative study between oral itraconazole and terbinafine in tinea infection  oral terbianfine 250mg will be given once a day for 6 weeks 
Intervention  comparative study between oral itraconazole and terbinafine in tinea infection  oral terbinafine 500mg will be given once a day for 6 weeks 
Comparator Agent  Nil  Nil 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  -all KOH positive tinea cases of age between 18 and 65 years
-body surface area involvement more than 5%
-patient giving written informed consent for study 
 
ExclusionCriteria 
Details  -pregnant and lactating women
-patient with preexisting renal, hepatic and cardiac disease
-patient with onychomycosis 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
By assessing dercrease in erythema, scaling, vesiculation, fissuring, maceration, exudation  baseline, 3 weeks, 6 weeks and 12 weeks 
 
Secondary Outcome  
Outcome  TimePoints 
to know about relapse  at 3 months follow up 
 
Target Sample Size   Total Sample Size="96"
Sample Size from India="96" 
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 3 
Date of First Enrollment (India)   27/10/2023 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report
    Response -  Analytic Code

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - For individual participant data meta-analysis.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [ankitanarola1@gmail.com].

  6. For how long will this data be available start date provided 03-05-2023 and end date provided 11-12-2025?
    Response - Immediately following publication. No end date.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary   patient will be recruited of tinea infection accroding to inclusion and exclusion criteria and primary outcome will be measured. In this study, efficacy of 130mg SB dose and 200mg dose of itraconazole given once a day and terbinafine 250mg and 500mg given once a day for 6 weeks will be compared. Also the species commonly found in tinea infection and drug and dose most effective against them will be identified. 
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