| CTRI Number |
CTRI/2024/08/071845 [Registered on: 02/08/2024] Trial Registered Prospectively |
| Last Modified On: |
02/08/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Treatment] |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Treating tinea cruris with satt e barg panwad. |
|
Scientific Title of Study
|
Evaluation of the efficacy of topical satt-i-barg-e- panwad with vinegar in the treatment of tinea cruris (Quba)-a single blind randomized standard controlled trial. |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Shiba Fathima |
| Designation |
post graduate resident |
| Affiliation |
luqman unani medical college bijapur |
| Address |
luqman unani medical college and hospital and research center bijapur 586101
Bijapur
KARNATAKA
586101
India |
| Phone |
8762271963 |
| Fax |
|
| Email |
shibafathima98@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr md qudratullah khan |
| Designation |
HOD and professor department of moalijat |
| Affiliation |
luqman unani medical college and research center |
| Address |
2nd floor department of moalijat luqman unani medical college and hospital and research centre 12 naubag vijayapur
Bijapur
KARNATAKA
586101
India |
| Phone |
9849438319 |
| Fax |
|
| Email |
drmqkhan@yahoo.com |
|
Details of Contact Person
Public Query
|
| Name |
Saba Mamdapur |
| Designation |
Associate professor |
| Affiliation |
luqman unani medical college bijapur |
| Address |
2nd floor department of moalijat Luqman unani medical college and hospital and reasearch center 12 naubag vijayapura
Bijapur
KARNATAKA
586101
India |
| Phone |
9611497816 |
| Fax |
|
| Email |
dr.sabamamdapur@gmail.com |
|
|
Source of Monetary or Material Support
|
| luqman unani medical college and hospital and research centre 12 naubag vijayapura karnataka 586101 |
|
|
Primary Sponsor
|
| Name |
shiba fathima |
| Address |
luqman unani medical college bijapur |
| Type of Sponsor |
Other [self] |
|
|
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 |
| shiba Fathima |
luqman unani medical college and hospital and research centre |
ground floor room no 1 general OPD department of moalijat LUMC
586101 bijapur karnataka
Bijapur
KARNATAKA |
8762271963
shibafathima98@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Communication of decision of the institutional ethics commitee for bio medical research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L089||Local infection of the skin and subcutaneous tissue, unspecified, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
barg e panwad. cassia tora lin
with vinegar |
form paste mode of application
frequency is twice daily
drug dosage quantity sufficient
contact period 1 hour
duration of intervension is 42 days wuth 14th 28th and 42nd day follow up
|
| Comparator Agent |
Clotrimazole 1% creame |
form cream mode of application
frequency topical twice daily
drug dosage quantity sufficient
contact period one hour
duration of 42 days with 14th 28th and 42nd day follow up |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patient diagnosed with tinea cruris (skin of the genitals, inner thighs and buttocks) clinically
as well as by KOH mount test without nail and scalp involvement.
Patient not taking any other drugs for tinea cruris.
Patient who are willing and able to provide informed consent.
Patient who are willing and able to understand and follow the protocol for the duration of the
study.
|
|
| ExclusionCriteria |
| Details |
1. Presence of complications such as secondary bacterial infection of the lesions.
2. Patients of tinea at other parts of body except tinea cruris.
3. Patients already on topical and/or systemic antifungal treatment (1 week of topical therapy and/or 4 weeks of systemic antifungal therapy before baseline visit)
4. patients with uncontrolled diabetes.
5. Immunosuppressant patients like AIDS/HIV infection.
6. pregnant and lactating women.
7. Noncompliance with the trial protocol. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. Change in Investigator’s global assessment(IGA)
2. Mycological cure: Clinically suspected cases of tinea cruris will be confirmed by skin scraping and KOH preparation, by visualizing presence or absence of long, narrow, septate and branching hyphae under microscope at baseline and at the conclusion of trial. |
at the baseline and at 6 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Change in TCS (Total clinical score.
2. Changes in Dermatology Life Quality Index. |
at the end of treatment |
|
|
Target Sample Size
|
Total Sample Size="40"
Sample Size from India="40"
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 2 |
|
Date of First Enrollment (India)
|
16/08/2024 |
| 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="6"
Days="1" |
|
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
|
Dermatophytosis is a roughness of the surface of the skin, which is associated with itching, scaling, and dryness. Sometime fish like scales may also shed off. It may be black or red in colour. Usually the periphery is red and occasionally there may be oozing of yellowish fluid. All these condition develop according to pathogenic dermatophytes. There are three different types of fungi which causes tinea cruris namely Microsporum, Trichophyton, and Epidermophyton. Dermatophytosis refer to superficial fungal infection of keratinized tissues caused by keratinophilic dermatophytes. Tinea varies with the site of infections as tinea corporis (at trunk region), tinea cruris(at groin region),tinea capitis(at head),tinea faciei(face),tinea pedis(feet),tinea manuum(hand), tinea unguium(nails). According to world health organization (WHO), the prevalence rate of superficial mycotic infection worldwide has been found to be 20-25%. Its prevalence varies indifferent countries. Tinea corporis (78.1%) was the commonest clinical presentation, followed by tinea cruris (10.1%), tinea manuum (2.5%), tinea faciei (1.8%), and tinea pedis (0.7%). It is more prevalent in tropical and subtropical countries like india where the heat and humidity is high for most part of the year. The dealcoholized leaves extract has shown the significant antifungal activity to inhibit the growth of candida albicans, aspergillus niger,saccharomyces cerevisiae and trichophyton mentagrophytes. Antifungal drugs exhibit marked adverse effects like hepatotoxicity, nephrotoxicity, and myelotoxicity. Resistance may be developed across most pathogens and causes drug target overexpression, efflux pump activation, and amino acid substitution. The experimental antifungal drugs in clinical trials are also reviewed. Whereas some intrinsic resistance has been found naturally, e.g., fluconazole-resistant. the acquired resistance has been a consequence of long-term therapies, widespread prophylaxis, or use of antifungals in agriculture, especially in the case of triazoles. Environmental exposure of fumigatus to triazole fungicides may explain their resistance in azole-naïve patients. Additionally, secondary resistance may occur after vertical and horizontal transmission in both animals and humans. Hence it is the need of the day to provide a safe and effective medicine, this was the main motivating factor behind the selection of this study, i.e., to evaluate safety and efficacy of Sat-e-barg-e-panwad as topical application in patients of quba |