| CTRI Number |
CTRI/2018/07/015063 [Registered on: 26/07/2018] Trial Registered Prospectively |
| Last Modified On: |
23/07/2018 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug |
| Study Design |
Randomized, Parallel Group, Multiple Arm Trial |
|
Public Title of Study
|
comparitive study of two antifungal medicines in treatment of superficial fungal infection |
|
Scientific Title of Study
|
Comparative study of efficacy of itraconazole and terbinafine with different doses and combination in the treatment of Tinea |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Satyendra Kumar Singh |
| Designation |
Professor and Head |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology and Venereology, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Satyendra Kumar Singh |
| Designation |
Professor and Head |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology and Venereology, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Satyendra Kumar Singh |
| Designation |
Professor and Head |
| Affiliation |
Institute of Medical Sciences |
| Address |
Department of Dermatology and Venereology, IMS, BHU
Varanasi
UTTAR PRADESH
221005
India |
| Phone |
9198120582 |
| Fax |
|
| Email |
drsatyendraderma@gmail.com |
|
|
Source of Monetary or Material Support
|
| Institutional research grant.
Institute of Medical Sciences, BHU. Varanasi. 221005, U.P |
|
|
Primary Sponsor
|
| Name |
IMS BHU |
| Address |
Department of Dermatology and Venereology.
IMS, BHU
Varanasi |
| 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 |
| Najuma Subba |
Sir Sunderlal Hospital |
skin opd no. 207, department of dermatology, IMS BHU
Varanasi
UTTAR PRADESH |
9198120582
najumasubba@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
Fungal infected stable patients., |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
different doses and combination of two systemic antifungal agents. |
follow up every 2 weeks to see clinical improvement for 8 weeks.
If there is no improvement after 4 weeks of treatment then it will be labelled as failure of the treatment. |
| Comparator Agent |
oral terbinafine, oral itraconazole |
there are total 5 arms.
1) tebinafine 250mg daily
2) itraconazole 200mg daily
3) terbinafine 250mg + itraconazole 200mg daily
4) terbinafine 250mg twice a day
5) itraconazole 200mg twice a day
the above drugs will be administed orally on daily bases for total duration of 8 weeks. failure cases will be treated for a total duration of 4 weeks. |
|
|
Inclusion Criteria
|
| Age From |
12.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Tinea cruris
Tinea corporis
Tinea faciei |
|
| ExclusionCriteria |
| Details |
weight more than 80 kg
Any other co-morbidities like hepatic disorders, renal disorders, cardiac disorders, etc.
history of oral antifungal agents within one month of start of study.
pregnancy.
lactation. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Complete clearance of skin lesions |
every 2 weeks for 8 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Experienced as primary outcome. |
Every 2 weeks for 8 weeks. |
|
|
Target Sample Size
|
Total Sample Size="275"
Sample Size from India="275"
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
|
N/A |
|
Date of First Enrollment (India)
|
06/08/2018 |
| 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
|
International Journal 7.
National Journal 30. |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
this is a comparative study with two drugs (terbinafine and itraconazole) with recommended daily doses, double daily doses and combination of both drugs with daily doses. Total study period is of 8 weeks. primary and secondary outcomes are complete clearing of skin lesions. |