| CTRI Number |
CTRI/2025/07/091245 [Registered on: 21/07/2025] Trial Registered Prospectively |
| Last Modified On: |
19/07/2025 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Assessment of the treatment efficacy of Terbinafine and Griseofulvin in treating the childhood fungal infections affecting the scalp and correlating it both with clinical and mycological aspects. |
|
Scientific Title of Study
|
ASSESSMENT OF THE THERAPEUTIC EFFICACY OF TERBINAFINE AND GRISEOFULVIN IN CHILDREN WITH TINEA CAPITIS ALONG WITH CLINICOMYCOLOGICAL CORRELATION |
| 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 Mohamed akram N |
| Designation |
Postgraduate |
| Affiliation |
Madras medical college |
| Address |
Department of DVL
Madras medical college and RGGGH
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
8838593180 |
| Fax |
|
| Email |
drmohamedakram94@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr R Madhu |
| Designation |
Associate Professor |
| Affiliation |
Madras medical college |
| Address |
Department of DVL
Madras medical college and RGGGH
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9344622731 |
| Fax |
|
| Email |
renmadhu08@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr R Madhu |
| Designation |
Associate Professor |
| Affiliation |
Madras medical college |
| Address |
Department of DVL
Madras medical college and RGGGH
Chennai
Chennai
TAMIL NADU
600003
India |
| Phone |
9344622731 |
| Fax |
|
| Email |
renmadhu08@gmail.com |
|
|
Source of Monetary or Material Support
|
|
|
Primary Sponsor
|
| Name |
Not applicable |
| Address |
Not applicable |
| 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 Mohamed akram N |
Madras medical college |
Department of DVL
Madras medical college and RGGGH
Chennai
Chennai
TAMIL NADU |
8838593180
drmohamedakram94@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE MADRAS MEDICAL COLLEGE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B350||Tinea barbae and tinea capitis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
GRISEOFULVIN |
Dose is given as per body weight. Dosage of 20 mg/kg body weight/ day of griseofulvin is taken orally for a period of 8 weeks |
| Intervention |
TERBINAFINE |
Based on body weight,
For people weighing 10-20 kg ,62.5 mg once in a day taken orally for 4 weeks.
For people weighing 20-40 kg, 125 mg once in a day taken orally for 4 weeks
For people weighing more than 40 kg 250 mg once in a day taken orally for 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
2.00 Year(s) |
| Age To |
18.00 Year(s) |
| Gender |
Both |
| Details |
Potassium hydroxide(KOH) wet mount positive cases of tinea capitis, Age group : greater than or equal to 2 years and lesser than or equal to 18 years of age, Patients who are willing to be enrolled in the study |
|
| ExclusionCriteria |
| Details |
Patients who have taken any oral or topical antifungal therapy within four weeks prior to inclusion in the study, Hepatic disease, Renal disease, Allergy to Griseofulvin and Terbinafine |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
|
|
Blinding/Masking
|
|
|
Primary Outcome
|
| Outcome |
TimePoints |
| Assessment of therapeutic efficacy of Terbinafine and Griseofulvin |
1 year |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Identification of species causing Tinea capitis |
1 year |
|
|
Target Sample Size
|
Total Sample Size="77"
Sample Size from India="77"
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)
|
30/07/2025 |
| 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 study is a randomised controlled trial comparing the therapeutic efficacy of oral Terbinafine and oral Griseofulvin in children(2-18 years) with tinea capitis and clinicomycological correlation at a single centre(Madras medical college). The primary outcome will be the assessment of therapeutic efficacy of terbinafine and griseofulvin.The secondary outcome will be the identification of species causing tinea capitis in children(2-18 years) |