CTRI Number |
CTRI/2020/03/023959 [Registered on: 13/03/2020] Trial Registered Prospectively |
Last Modified On: |
12/03/2020 |
Post Graduate Thesis |
Yes |
Type of Trial |
Interventional |
Type of Study
|
Drug |
Study Design |
Randomized, Parallel Group Trial |
Public Title of Study
|
Clinicomycological study and efficacy of antifungal treatment in dernatophytosis. |
Scientific Title of Study
|
Clinicomycological Study and Efficacy of Antifungal treatment in patients of Dermatophytosis in Department of Dermatology, GMERS Medical College And General Hospital, Gotri , Vadodara.
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Trial Acronym |
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Secondary IDs if Any
|
Secondary ID |
Identifier |
NIL |
NIL |
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
Name |
Dr Grishma kanak fumtiwala |
Designation |
dermatology resident |
Affiliation |
GMERS medical college and hospital,gotri,vadodara |
Address |
Opd 205, GMERS Medical College And Hospital,Gotri, Vadodara Room 304 , Resident Hostel, GMERS Medical College And Hospital, Gotri, Vadodara Vadodara GUJARAT 392001 India |
Phone |
8128281353 |
Fax |
|
Email |
grishmafumtiwala13@gmail.com |
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Details of Contact Person Scientific Query
|
Name |
Dr Raksha patel |
Designation |
Professor And Head Of Department |
Affiliation |
GMERS medical college and hospital,gotri,vadodara |
Address |
OPD 205, GMERS Medical College And Hospital, Gotri, Vadodara
Vadodara GUJARAT 390021 India |
Phone |
09426570097 |
Fax |
|
Email |
rakshamp@yahoo.co.in |
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Details of Contact Person Public Query
|
Name |
Dr Grishma kanak fumtiwala |
Designation |
dermatology resident |
Affiliation |
GMERS medical college and hospital,gotri,vadodara |
Address |
Opd 205,GMERS Medical College And Hospital , Gotri, Vadodara
390021
Vadodara GUJARAT 390021 India |
Phone |
8128281353 |
Fax |
|
Email |
grishmafumtiwala13@gmail.com |
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Source of Monetary or Material Support
|
Gmers gotri medical hospital vadodara |
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Primary Sponsor
|
Name |
GMERS Medical College And Hospital Gotri |
Address |
Opd 205, GMERS Medical College And Hospital , Gotri, Vadodara |
Type of Sponsor |
Government medical college |
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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 |
Grishma fumtiwala |
Gmers medical college and hospital |
Opd 205 ,gmers medical college and hospital gotri, vadodara Vadodara GUJARAT |
8128281353
grishmafumtiwala13@gmail.com |
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Details of Ethics Committee
|
No of Ethics Committees= 1 |
Name of Committee |
Approval Status |
Institutional Human Ethics Committee |
Approved |
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Regulatory Clearance Status from DCGI
|
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Health Condition / Problems Studied
|
Health Type |
Condition |
Patients |
, (1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
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Intervention / Comparator Agent
|
Type |
Name |
Details |
Comparator Agent |
Clinicomycological Study And Efficacy Of Antifungals Terbinafene, Fluconazole And Itraconazole In Treatment Of Dermatophytosis |
compare efficacy of antifungals Terbinafene, Fluconazole And Itraconazole in Treatment Of Dermatophytosis |
Intervention |
Efficacy of antifungal treatment in detmatophytosis |
efficacy of terbinafene, fluconazole and itraconazole in treatment of dermatophytosis.
Tablet Fluconazole (150mg) Twice weekly for 15 days
Tablet Terbinafene (500mg) 1 od for 15 days
Tablet Itraconazole (200mg) 1 od for 15 days |
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Inclusion Criteria
|
Age From |
18.00 Year(s) |
Age To |
60.00 Year(s) |
Gender |
Both |
Details |
Patients of either sex
Patients 18 years or above
Patient is suffering from dermatophyte infection diagnosed clinically
Patient is suffering from dermatophyte infection in body and genitals
Patients with scaling present on lesion
Ability to give oral informed consent
|
|
ExclusionCriteria |
Details |
Patient has been treated with oral or topical antifungal agents in last 3 months
Patient on steroid therapy
Patient having H/o hypersensitivity to above mentioned drugs
Pregnancy or lactating mother
Patient having any abnormal CVS, Renal , Hepatic functions or uncontrolled Diabetes Mellitus or HIV
Patient who can’t come for regular follow up
|
|
Method of Generating Random Sequence
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Other |
Method of Concealment
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Sequentially numbered, sealed, opaque envelopes |
Blinding/Masking
|
Participant and Investigator Blinded |
Primary Outcome
|
Outcome |
TimePoints |
ClinicalAnd Statistical Cure in pruritus, erythema and scaling score
Improvement in Global Assessment scale Mycological cure by studying KOH
|
ClinicalAnd Statistical Cure in pruritus, erythema and scaling score
Improvement in Global Assessment scale
Mycological cure by studying KOH
Outcome will be assessed after 1 year at the end of study
Patient will be follwed up after 15 days
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Secondary Outcome
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Outcome |
TimePoints |
Improvement in global assessment score and mycological cure in koh |
improvement in global assessment score and mycological cure in koh
Outcome will be asssessed after 1 year at the end of study.
Patient will be followed up at interval of 15 days. |
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Target Sample Size
|
Total Sample Size="180" Sample Size from India="180"
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)
|
14/03/2020 |
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
|
NIL |
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
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Brief Summary
|
Superficial
fungal infection due to dermatophytosis is one of the most common skin
infections in the India.It is contagious. The dermatophytes are a group of
fungi that invade the superficial layer of epidermis and degrade the
keratinized tissues of skin, hair and nails in living animals including man,
causing ring worm. (1)(2) But in rare cases they invade the deeper layer of the
dermis and other organs. A dermatophyte infection results in increased skin
proliferation, scaling, and epidermal thickening.
Dermatophytosis
is the fungal infection of keratinized tissue. It is caused by three asexual
genera- Trichophyton, Epidermophyton, and Microsporum. Dermatophytes are
filamentous, keratinophilic, pathogenic fungi which are readily identified by
microscopic examination of clinical specimen and can be cultured easily in
laboratory. Depending on their habitat, they can be categorized as geophilic,
zoophilic and anthropophilic.Based upon the affected site, these
have been classified clinically into tinea capitis (head), tinea facei (face),
tinea barbae (beard), tinea corporis (body), tinea mannum (hand), tinea cruris
(groin), tinea pedis (foot), and tinea unguium (nail).
Fluconazole,
terbinafine, itraconazole are commonly used antifungal agent in
dermatophytosis. Resistance to these drugs is being seen increasingly when used
in conventional doses and duration.
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