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CTRI Number  CTRI/2024/01/061906 [Registered on: 29/01/2024] Trial Registered Prospectively
Last Modified On: 03/01/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Study on itraconazole vs griseofulvin in treatment of tinea. 
Scientific Title of Study   Comparative study on efficacy of oral ultramicrosized Griseofulvin and Itraconazole on dermatophytic infection of skin 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Amarjeet 
Designation  Junior Resident 
Affiliation  ERA lucknow medical college 
Address  Department of dermatology ERA Lucknow medical college, Sarfarazganj, Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
2260003
India 
Phone  7411803169  
Fax    
Email  doctor.amarjeet@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Kshitij Saxena  
Designation  Professor  
Affiliation  ERA lucknow medical college 
Address  Department of dermatology ERA Lucknow medical college, Sarfarazganj, Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
2260003
India 
Phone  9208015391  
Fax    
Email  drkshitijsaxena@live.com  
 
Details of Contact Person
Public Query  
Name  Amarjeet 
Designation  Junior Resident 
Affiliation  ERA lucknow medical college 
Address  Department of dermatology ERA Lucknow medical college, Sarfarazganj, Lucknow Uttar Pradesh

Lucknow
UTTAR PRADESH
2260003
India 
Phone  7411803169  
Fax    
Email  doctor.amarjeet@gmail.com  
 
Source of Monetary or Material Support  
Era Lucknow Medical College and Hospital , Lucknow  
 
Primary Sponsor  
Name  Eras Lucknow Medical College and Hospital 
Address  Second Floor , Department of Dermatology, Eras Lucknow Medical College and Hospital 
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 
Dr Amarjeet  Eras Lucknow Medical College and Hospital  Room No-2 ,Second Floor , Department of Dermatology, Eras Lucknow Medical College and Hospital, Sarfarazganj
Lucknow
UTTAR PRADESH 		 7411803169

doctor.amarjeet@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
institutional ethic committee  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 
Comparator Agent  Itraconazole  Anti-fungal drug - Dose: 100 mg - Frequency: Twice Daily - Route: Oral - Follow up at 2 weeks, 4 weeks, 6 weeks and 8 weeks. - Duration of Study: 8 weeks After the completion of trial period, treatment of the patient with drug shall continue if necessary. 
Intervention  Ultramicrosized Griseofulvin  Anti-fungal drug - Dose: 500 mg - Frequency: Twice Daily - Route: Oral - Follow up at 2 weeks, 4 weeks, 6 weeks and 8 weeks. - Duration of Study: 8 weeks After the completion of trial period, treatment of the patient with drug shall continue if necessary. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Freshly diagnosed patients of age 18 years and above with clinical diagnosis of tinea corporis and tinea cruris confirmed by potassium hydroxide (KOH) test attending the dermatology OPD at ELMC&H.
 
 
ExclusionCriteria 
Details  Previously treated patient within 3 months.Patients with pre-existing renal disease, hepatic disease and cardiac disease.Pregnant & lactating women
 
 
Method of Generating Random Sequence   Other 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant, Investigator and Outcome Assessor Blinded 
Primary Outcome  
Outcome  TimePoints 
To observe the efficacy of oral Itraconazole and Ultramicrosized Griseofulvin in dermatophytic infection.
 		 0,2,4 and 8 weeks  
 
Secondary Outcome  
Outcome  TimePoints 
To study the clinical response of dermatophytic infection to oral Itraconazole.
To study the clinical response of dermatophytic infection to oral Ultramicrosized Griseofulvin 		 8 weeks 
 
Target Sample Size   Total Sample Size="240"
Sample Size from India="240" 
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 4 
Date of First Enrollment (India)   30/01/2024 
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 Yet Recruiting 
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  
A total of 240 patients presenting to the Department of Dermatology, Eras Lucknow Medical College and Hospital, Lucknow of clinical diagnosis of Tinea Corporis and Tinea Cruris confirmed by potassium hydroxide (KOH) test will be approached for participation in the study. Patients meeting the inclusion and exclusion criteria and giving written consent for participating in the study shall be recruited. History, complete clinical & micobiological examination with photographic documentation will be done before starting treatment and then at each visit. Patients will be randomly divided into two groups – A and B each containing 120 individuals. In group A – Patients will be given oral Itraconazole 100mg twice daily for 8 weeks. In group B – Patients will be given oral ultramicrosized Griseofulvin 500 mg for 8 weeks. Patients will be followed up at 2, 4, and 8 weeks and at each follow-up visit assessment of clinical response  to treatment and photograph will be taken and therapeutic efficacy will  be graded. 
If at any point, any patient withdraws the consent  or does not come for 2 consecutive follow-ups despite telephonic reminders. He/She shall be considered dropped out of the study. If and when required CBC, LFT and KFT will be done if abnormality detected, then patient will be excluded from the study.
 
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