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CTRI Number  CTRI/2025/03/082632 [Registered on: 18/03/2025] Trial Registered Prospectively
Last Modified On: 12/03/2025
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   Efficacy of topical Unani formulation in the pateints of Tinea Corporis: An open-label, randomised controlled trial 
Scientific Title of Study   Therapeutic efficacy of a topical unani formulation containing Sirka and Samgh-i-Arabi in the management of Quba Khabith (Tinea Corporis): An open labeled, randomised clinical trial with standard control 
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 Asgar Nazir 
Designation  Lecturer Department of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  6005516889  
Fax    
Email  drasgarnazir11@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Asgar Nazir 
Designation  Lecturer Department of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  6005516889  
Fax    
Email  drasgarnazir11@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Adnan Ali 
Designation  PG Scholar 
Affiliation  Regional Research Institute of Unani Medicine (RRIUM), Srinagar 
Address  Department of Moalajat RRIUM Naseem Bagh Campus of University of Kashmir Srinagar Jammu and Kashmir

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9212999960  
Fax    
Email  dr.adnan.ali999@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine (CCRUM), New Delhi 110058, India.  
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine CCRUM New Delhi India 
Address  Regional Research Institute of Unani Medicine (RRIUM), University of Kashmir, Srinagar 190006, India.  
Type of Sponsor  Research institution and hospital 
 
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 Asgar Nazir  Regional Research institute of unani medicine(RRIUM) Srinagar  Moalajat OPD-1, Ground Floor, Department of Moalajat, RRIUM, Naseem bagh Campus, University of Kashmir Hazratbal Srinagar JAMMU & KASHMIR
Srinagar
JAMMU & KASHMIR 
6005516889

drasgarnazir11@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee, RRIUM Srinagar  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Semi-solid unani formulation  Compound Test drug formulation in semi-solid form with two main ingredients, Sirka, and Samgh-i-Arabi, for topical application. Both ingredients, Sirka and Samgh-i-Arabi, will be mixed in equal quantities to form the solution. In patients in the the test group, compound test drug formulation will be applied locally twice a day for 28 days. Topical antifungal medication will be used to the lesion at least 2 cm beyond the margin.  
Comparator Agent  Terbinafine cream 1% for local application  Topical antifungal medication is to be applied twice a day locally for 28 days.  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  1. Patients diagnosed with Quba Khabith (tinea corporis)
2. Patients in the age group of 18 to 60 irrespective of gender
3. KOH (potassium hydroxide) positive
4. Patients willing to sign written informed consent
 
 
ExclusionCriteria 
Details  1. Patients below the age of 18 years and above 60 years
2. History of drug-induced allergy
3. Pregnant or breastfeeding mothers
4. Active case of malignancy
5. Patients having diabetes mellitus or cardiovascular or renal diseases.
6. Unwillingness or inability to fulfill the protocol or patients who fail to consent.
7. KOH (potassium hydroxide) negative
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
1. Typical Lesion with itching, Scaling, Erythema, Papules, Vesicles
2. KOH (potassium hydroxide) Negative
3. TSSS (Total sign and symptoms score)  
7th, 14th, 21st, and 28th day of the study. KOH will be assessed on 0th and 29th (before and after)  
 
Secondary Outcome  
Outcome  TimePoints 
1. DLQI (Dermatology life quality index)
2. Pre and Post photograph of the lesion site 
0th and 29th (Before and After) 
 
Target Sample Size   Total Sample Size="52"
Sample Size from India="52" 
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)   10/04/2025 
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="0"
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 - NO
Brief Summary  

Tinea corporis is variously named ringworm, dermatophytosis, favus, or daad.  It is a clinical condition caused by a fungal infection of the skin, hair, and nails. The fungus is keratophyllic affecting the outer layer of the skin to produce ring-shaped lesions with a papulo-vesicular margin and central clear area.  According to WHO estimates, tinea corporis infects between 20 to 25% of the world population. It occurs most frequently in post-pubertal children and young adults with no sex differentiation. Climate conditions all around the world have influenced the incidence variability. Many effective synthetic antifungal drugs have been discovered for the treatment of tinea corporis, but their use has remained limited due to various side effects. Unani herbal medicine, whether a single herb, compound formulations, or regimental therapy, has also been used for this purpose since ancient times. However, only a few of them have been evaluated on scientific grounds for their efficacy. The need of the hour is to validate the herbal preparations mentioned in our classical texts, which are otherwise safe, fairly available, and easily affordable by the general public, on scientific parameters. In this context, we selected a trial to evaluate the therapeutic efficacy of a topical unani formulation containing Sirka and Samgh -i-Arabi in the management of Quba Khabith (Tinea corporis), which is a randomized study with standard control.

 
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