FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/02/080348 [Registered on: 12/02/2025] Trial Registered Prospectively
Last Modified On: 07/02/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment Ringworm (tinea corporis) with polyherbal unani formulation 
Scientific Title of Study   Therapeutic Evaluation of Unani polyherbal formulation in the treatment of Quba (tinea corporis)-A randomized open-labelled standard control clinical 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  Dr Syeda Nashim Banu 
Designation  PG scholar 
Affiliation   
Address  Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  09402957690  
Fax    
Email  syedanashim2@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohd Qudratullah khan 
Designation  Professor department of Moalijat 
Affiliation   
Address  Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  9849438319  
Fax    
Email  drmqkhan@yahoo.com  
 
Details of Contact Person
Public Query  
Name  Dr Salma Chaush 
Designation  Professor 
Affiliation   
Address  Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura Karnataka

Bijapur
KARNATAKA
586101
India 
Phone  7975343527  
Fax    
Email  drsalmachaush86@gmail.com  
 
Source of Monetary or Material Support  
Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura Karnataka 586101 
 
Primary Sponsor  
Name  Luqman unani medical college and hospital  
Address  Luqman Unani Medical College Hospital and Research Centre 12 Naubag Vijayapura Karnataka 
Type of Sponsor  Private medical college 
 
Details of Secondary Sponsor  
Name  Address 
NIL  NIL 
 
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 Nashim Banu  Luqman Unani Medical College Hospital and Research Centre  Ground floor 2nd number opd in Luqman Hospital and Research center 12 Naubag Vijayapura Karnataka 586101
Bijapur
KARNATAKA 		 9402957690

syedanashim2@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Communication of Decision of the Institutional Ethical Committee for Bio Medical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
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 
Comparator Agent  Terbinafine 1% cream  Form cream Mode of application topical once a day Drug dosage quantity sufficient Contact period 20 minutes Follow up 14th, 28th and 42ndday 
Intervention  Unani polyherbal formulation i.e bekh-e-anjeerdasti babchi tukhme panwar narkachoor   Form: Soak 6 grams of each drug in 100 mL of water overnight. Zulal (decanted water) for oral use and Sufl (sediment) used topically. Mode of application topically sufl and orally zulal daily morning Drug dosage 24gm in 100 ml of water Contact period 20 minutes  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  1. Patient diagnosed with tinea corporis clinically, as well as by KOH mount test without nail and scalp involvement.
2. BSA less then or equal to 20 percent.
3. Patient who are willing and able to provide informed consent.
 
 
ExclusionCriteria 
Details  1. Presence of complications such as secondary bacterial infection of the lesions.
2. 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)
3. Patients with diabetes mellitus.
4. Immunosuppressant patients like AIDS/HIV infection.
4. Pregnant and lactating women.
5. Noncompliance with the trial protocol.


 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Change in Investigator’s global assessment(IGA)of clinical responses (see annexure-II for details)
2. Mycological cure: Clinically suspected cases of tinea corporis 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.



 		 14th, 28th and 42nd day.

 
 
Secondary Outcome  
Outcome  TimePoints 
1. Change in TCS (Total clinical score) (see Annexure-III for details)
2. Changes in Dermatology Life Quality Index (see Annexure-IV for details)
 		 14th, 28th and 42nd day.
 
 
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)   26/02/2025 
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="6"
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 - YES
  1. What data in particular will be shared?
    Response - Individual participant data that underlie the results reported in this article, after de-identification (text, tables, figures, and appendices).

  2. What additional supporting information will be shared?
    Response -  Study Protocol
    Response -  Statistical Analysis Plan
    Response - Informed Consent Form
    Response - Clinical Study Report

  3. Who will be able to view these files?
    Response - Researchers who provide a methodologically sound proposal.

  4. For what types of analyses will this data be available?
    Response - To achieve aims in the approved proposal.

  5. By what mechanism will data be made available?
    Response - Proposals should be directed to [syedanashim2@gmail.com].

  6. For how long will this data be available start date provided 02-01-2027 and end date provided 02-01-2032?
    Response - Beginning 3 months and ending 5 years following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIll
Brief Summary   Quba (dermatophytosis/tinea) is a infection of keratinized tossues (epidermis,hair,nails) caused by dermatophytes, primarily Trichophyton rubrum. It is classified based on the infection site, including tinea capitis,tinea corporis,tinea cruris ,tinea pedis and tinea unguium. The prevalence depend ons on host and environmental factors, affecting 20-25% of the global population, with India reporting a 36.6-78.4% prevalence. Tinea corporis is the most common form , followed by tinea cruris.
Treatment includes topical (azoles like ketoconazole, lulliconazole,clotrimazole) and oral antifungals (turbinafine,fluconazole,itraconazole,griseofulvin), but concerns over drug resistance, recurrence and toxicity (hepatotoxicity, nephrotoxicity ,myelotoxicity) persist.
in Unani medicine, Quba (Daad) is attributed to Mirrasawda (bilious melancholy) or Rutubat-i-Ghaliz and Balgham-i-Shor (saline phlegm) in the blood, redirected peripherally by Quwwat- i- Tabiyya, leading to pruritic skin.Treatments involve Tehlil-e-warm,Taltif -e-madda,Taskin, and Tartib, using systemic and topical agents like roghan-e-gandum, marham-henna, marhan-e-quba, and paste of mazu mixed with cow urine, as well as Joshand-e-aftimoon for systemic therapy.
Classical Unani texts highlight Anjirdashti, Tukhm e panwar, Babchi, and Narkchoor for effective Quba treatment, but scientific validation is lacking. The current study, "Therapeutic Evaluation of Unani Polyherbal Formulation in the Treatment of Quba (Tinea Corporis)", is a randomized, open-label, standard-controlled clinical trial designed to evaluate the efficacy and safety of this formulation.
 
Close