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CTRI Number  CTRI/2025/03/083050 [Registered on: 21/03/2025] Trial Registered Prospectively
Last Modified On: 19/03/2025
Post Graduate Thesis  No 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Single Arm Study 
Public Title of Study   PreClinical and clinical studies to evaluate safety and Efficacy of a Topical Unani formulation in Dermatophytosis. 
Scientific Title of Study   Preclinical and Clinical studies to evaluate the safety and efficacy of Unani Topical Formulation for Dermatophytosis. 
Trial Acronym  NIL 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  PROF ZAMIR AHMAD 
Designation  PROFESSOR 
Affiliation  AJMAL KHAN TIBBIYA COLLEGE 
Address  Department of Amraze Jild wa Zohrawiya, Faculty of Unani Medicine Aligarh Muslim University Aligarh
SAME
Aligarh
UTTAR PRADESH
2020002
India 
Phone  8475007594  
Fax    
Email  drzamiramrohi@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  PROF ZAMIR AHMAD 
Designation  PROFESSOR 
Affiliation  AJMAL KHAN TIBBIYA COLLEGE 
Address  Department of Amraze Jild wa Zohrawiya, Faculty of Unani Medicine Aligarh Muslim University Aligarh
SAME
Aligarh
UTTAR PRADESH
2020002
India 
Phone  8475007594  
Fax    
Email  drzamiramrohi@gmail.com  
 
Details of Contact Person
Public Query  
Name  PROF ZAMIR AHMAD 
Designation  PROFESSOR 
Affiliation  AJMAL KHAN TIBBIYA COLLEGE 
Address  Department of Amraze Jild wa Zohrawiya, Faculty of Unani Medicine Aligarh Muslim University Aligarh
SAME
Aligarh
UTTAR PRADESH
2020002
India 
Phone  8475007594  
Fax    
Email  drzamiramrohi@gmail.com  
 
Source of Monetary or Material Support  
CENTRAL COUNCIL OF UNANI MEDICINE,MINISTRY OF AYUSH, GOVT. OF INDIA 
 
Primary Sponsor  
Name  CENTRAL COUNCIL OF UNANI MEDICINE,MINISTRY OF AYUSH, GOVT. OF INDIA 
Address  CCRUM HEADQUARTER No.61-65, Institutional Area, Opp. D Block, Janakpuri, New Delhi - 110058 ( India) 
Type of Sponsor  Government funding agency 
 
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 Sana Rehman  OPD 3, AJMAL KHAN TIBBIYA COLLEGE  AJMAL KHAN TIBBIYA COLLEGE , A.M.U,ALIGARH,U.P.
Aligarh
UTTAR PRADESH 		 8218917223

sanarehman72@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
INSTITUTIONALETHICALCOMMITTEE  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  ,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  NA  NA  
Intervention  Unani Formulated Ointment (UFO)  Contains: Sulphur(Gandhak) Borax(Suhaga) Ammonium Chloride(Naushadar) Limestone(Ahak ) Quercus incana (Mazu) Allium sativum(Lehsun) Roghan Kunjud( Sesame oil) Excipiennts 
 
Inclusion Criteria  
Age From  16.00 Year(s)
Age To  65.00 Year(s)
Gender  Both 
Details  fungal hyphae in a 10% potassium hydroxide (KOH)
Patients aged 14year old to 65 years old. 
 
ExclusionCriteria 
Details  Immunocompromised
Pregnant ladies
Lactating women
Patients with secondarily infected or eczematized lesions

Medical comorbidities
Uncontrolled Diabetes 
 
Method of Generating Random Sequence   Not Applicable 
Method of Concealment   Not Applicable 
Blinding/Masking   Not Applicable 
Primary Outcome  
Outcome  TimePoints 
To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis.  To evaluate the safety and effficacy of the Unani Formulated Ointment in Dermatophytosis. 
 
Secondary Outcome  
Outcome  TimePoints 
Correlate the efficacy with the MIC.  20/04/25 
 
Target Sample Size   Total Sample Size="30"
Sample Size from India="30" 
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)   01/04/2025 
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="0"
Months="3"
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 [drzamiramrohi@gmail.com].

  6. For how long will this data be available start date provided 31-10-2025 and end date provided 30-12-2026?
    Response - Beginning 9 months and ending 36 months following article publication.

  7. Any URL or additional information regarding plan/policy for sharing IPD? 
    Additional Information - NIL
Brief Summary  

 Study will be conducted on 30 patients of either sex supported by inclusion, exclusion criteria with informed consent.

Prior to the conduction of the study, safety evaluation of the formulation was evaluated. The following parameters also being noted:

1- Primary Irritation study: 24-, 48-hour 72 or 96-hour single-application patch tests to evaluate the primary irritation (acute skin irritation) potential of test drug, if any.

2-Cumulative Patch Irritation study: It is conducted to evaluate the test drug to assess if a chemical ingredient present in the test drug have the potential to cause contact irritation or contact allergy in the skin. 14-day or 21-day patch test is used to investigate the potential irritation from chronic exposure.

3-Forearm Controlled application test (FCAT): Helps to quickly evaluate the relative skin benefits of various skin formulations.

 
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