| CTRI Number |
CTRI/2025/11/096934 [Registered on: 06/11/2025] Trial Registered Prospectively |
| Last Modified On: |
06/11/2025 |
| Post Graduate Thesis |
No |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
A Study on the Effect of Unani and Modern Medicines in Treating Fungal Skin Infection |
|
Scientific Title of Study
|
A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to compare the Efficacy of Qurs-e-Asfar(O) and Marham-e-Dad (L) with Itraconazole(O) and Terbinafine (L) in the Management of Quba (Dermatophytosis) along with Gene expression and Biomarkers Analysis |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Syeda Hajra Fatima |
| Designation |
Research officer Pathology Scientist level II |
| Affiliation |
National Research Institute of Unani medicine for Skin Disorders |
| Address |
Department of Pathology, National Research Institute of Unani medicine for Skin Disorders, Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
7981875992 |
| Fax |
|
| Email |
dr.syeda.hajra04@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Syeda Hajra Fatima |
| Designation |
Research officer Pathology Scientist level II |
| Affiliation |
National Research Institute of Unani medicine for Skin Disorders |
| Address |
Department of Pathology, National Research Institute of Unani medicine for Skin Disorders, Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
7981875992 |
| Fax |
|
| Email |
dr.syeda.hajra04@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Syeda Hajra Fatima |
| Designation |
Research officer Pathology Scientist level II |
| Affiliation |
National Research Institute of Unani medicine for Skin Disorders |
| Address |
Department of Pathology, National Research Institute of Unani medicine for Skin Disorders, Erragadda, Hyderabad.
Hyderabad
TELANGANA
500038
India
Hyderabad
TELANGANA
500038
India |
| Phone |
7981875992 |
| Fax |
|
| Email |
dr.syeda.hajra04@gmail.com |
|
|
Source of Monetary or Material Support
|
| Central Council for Research in Unani Medicine, Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No. 61-65 Institutional Area Opposite D Block Janakpuri New Delhi India pincode 110058 |
|
|
Primary Sponsor
|
| Name |
Central Council for Research in Unani Medicine |
| Address |
Jawahar Lal Nehru Bhartiya Chikitsa Avum Homeopathy Anusandhan Bhavan No. 61-65 Institutional Area Opposite D Block Janakpuri New Delhi 110058 |
| Type of Sponsor |
Research institution and hospital |
|
|
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 syeda hajra fatima |
National Research Institute of Unani medicine for Skin Disorders |
Room no. 44, Department of Pathology, AG COLONY ROAD, Erragadda, Hyderabad, 500038, Telangana, India.
Hyderabad
TELANGANA |
7981875992
dr.syeda.hajra04@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, (2) ICD-10 Condition: B356||Tinea cruris, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Itraconazole |
Participants in the Control Group will receive Itraconazole tablets (100 mg) twice daily after food |
| Intervention |
Marham-e- Dad |
Marham-e-Dad cream, mixed with vinegar, will be applied locally on the affected area twice daily to study group participants |
| Intervention |
Qurs-e-Asfar |
Participants in the Study Group will receive Qurs-e-Asfar tablets - 01 tablet twice daily after food. |
| Comparator Agent |
Terbinafine cream |
Terbinafine 1% cream will be applied locally on the affected area twice daily in the Control Group participants |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Participants of Quba Tinea Corporis (body) & Tinea Cruris (groin) having Circumscribed lesions having any of the following signs and Symptoms: Presence of pruritus and burning, Presence of scales, Presence of central clearing, Erythematous papules. Participants with positive mycology (KOH positive). Willingness to participate in the study and follow the schedule
|
|
| ExclusionCriteria |
| Details |
Participants below 18 years or above 60 years of age, pregnant or lactating women, and those having other forms of tinea infection such as Tinea capitis (scalp), Tinea pedis (foot), Tinea manuum (hands), Tinea unguium (nails), Tinea barbae (beard), or Tinea faciei (face) will be excluded from the study. Patients suffering from psoriasis, eczema, diabetes mellitus, pulmonary, cardiovascular, hepatic, or renal dysfunction, or any immunocompromised condition such as HIV/AIDS will also be excluded. Participants unwilling to attend the treatment schedule regularly, those with a history of hypersensitivity to Itraconazole or Terbinafine, and those who have used systemic antifungal or corticosteroid therapy in the previous two weeks will not be included in the study. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Sequentially numbered, sealed, opaque envelopes |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Topical and oral treatment with Unani formulations Qurs-e-Asfar and Marham-e-Dad is expected to resolve the clinical signs and symptoms of Quba (Dermatophytosis) and achieve mycological cure, evidenced by negative findings in KOH mount, with minimal side effects as compared to the control drugs |
8 week |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To evaluate changes in gene expression levels of CXCL8, CXCL1, and TSG6, and to measure serum protein biolevels of IL6, IL17, IL23, and TNF alfa in Quba infected patients before and after treatment, in order to understand their role in the therapeutic response and pathogenesis of the disease |
8 week |
|
|
Target Sample Size
|
Total Sample Size="59"
Sample Size from India="59"
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/ Phase 3 |
|
Date of First Enrollment (India)
|
04/12/2025 |
| 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="3"
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
|
Dermatophytosis is a common fungal skin infection, particularly prevalent in tropical regions like India, often causing recurrent lesions and resistance to standard antifungal drugs. The present single-center, randomized, open-label, active-controlled, parallel-group clinical study aims to evaluate the efficacy and safety of Unani formulations Qurs-e-Asfar (oral) and Marham-e-Dad (topical)—in participants of Quba also called as Tinea corporis (body) and Tinea cruris (groin), in comparison to standard antifungal drugs. The study will also assess gene expression changes (CXCL-8, CXCL-1, and TSG-6) using RT-PCR and measure serum biomarker levels (IL-6, IL-17, IL-23, and TNF-alfa) by ELISA before and after treatment, to understand their association with therapeutic outcomes. This research seeks to provide scientific validation for Unani medicines in managing Quba and explore genetic and protein biomarkers contributing to disease pathogenesis and treatment response |