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CTRI Number  CTRI/2025/03/081866 [Registered on: 06/03/2025] Trial Registered Prospectively
Last Modified On: 17/02/2025
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   Evaluating efficacy and Safety of a topical Unani Formulation in the treatment of Kalaf(Melasma) 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a topical Unani Formulation in the treatment of Kalaf (Melasma) 
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 Nameera Zehra 
Designation  PG scholar 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  National Research Institute of Unani Medicine for Skin Disorders AG Colony Road opp ESI hospital Erragadda Hyderabad 500038 Telangana

Hyderabad
TELANGANA
500038
India 
Phone  7879783248  
Fax    
Email  ansarinameera009@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Prof Qamar Uddin 
Designation  Professor 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat NRIUMSD Ag colony, road Opp ESI hospital, Erragadda, Hyderabad 500038 Telangana

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  qamaruddindr@gmail.com  
 
Details of Contact Person
Public Query  
Name  Prof Qamar Uddin 
Designation  Professor 
Affiliation  National Research Institute of Unani Medicine for Skin Disorders 
Address  Department of Moalajat NRIUMSD Ag colony, road Opp ESI hospital, Erragadda, Hyderabad 500038 Telangana

Hyderabad
TELANGANA
500038
India 
Phone  8700027178  
Fax    
Email  qamaruddindr@gmail.com  
 
Source of Monetary or Material Support  
National Research Institute of Unani Medicine for Skin Disorders, Hyderabad  
 
Primary Sponsor  
Name  National Research Institute of Unani Medicine for Skin Disorders 
Address  Ag colony, road Opp ESI hospital, Erragadda, Hyderabad 500038 Telangana 
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 Nameera Zehra  National Resaerch Institute of Unani Medicine for Skin Disorders  OPD and IPD of National Research Institute of Unani Medicine for Skin Disorders, AG colony road, Opp ESI hospital, Erragadda, Hyedrabad
Hyderabad
TELANGANA 		 7879783248

ansarinameera009@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  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Hydroquinone 4% cream  Participants will be advised to apply Hydroquinone 4% cream topically on affected sites twice daily for 4 weeks.  
Intervention  Topical Unani Formulation  Dosage form-: Qurs (tablet) for topical application Mode of Administration: Qurs will be crushed and Zimad (paste) for topical application will be prepared by mixing the crushed pill with Sirka (vinegar) and participants will be advised to apply the prepared Zimad (paste) on the affected site twice daily for 4 weeks Dosage Sufficient Quantity to be applied  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  The following patients will be included in the study
Participants of any gender in the age group of 18-60 years
Participants having bilateral symmetrical or asymmetrical brown macules on face
Participants who are willing to participate and comply with the protocol and to sign IEC approved ICF
 
 
ExclusionCriteria 
Details  Exclusion Criteria
The following patients will be excluded from the study
Participants aged less than 18 years and
more than 60 years of age
Pregnant or Lactating Women
Mentally retarded person
Known allergy, sensitivity or intolerance to the study drug or any of its ingredients
Known case of significant Pulmonary/Cardiovascular/Hepato-renal Dysfunction, Malignancy, HIV infection, AIDS, Hypothyroidism, Diabetes Mellitus, etc
Participants not willing to give consent and to attend treatment schedule regularly
 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in MASI Score from baseline after 4 weeks of treatment.   28 days 
 
Secondary Outcome  
Outcome  TimePoints 
Change in Melasma Quality of Life (MELASQoL) Scale Score from baseline after 4 weeks of treatment.
Assessment of Safety (Local & Systemic)
 		 28 days 
 
Target Sample Size   Total Sample Size="60"
Sample Size from India="60" 
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)   02/06/2025 
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 - NO
Brief Summary  

Melasma (Greek: “a black spot”) is an acquired lighter dark-brown hyperpigmentation on face. It presents 0.25 to 4% of dermatology clinic patients in Southeast Asia. Females are more affected than males. Melasma has been treated with modern topical medicines such Hydroquinone, Tretinoin, Tranexamic Acid, Azelaic acid and Triple Combination Cream but the negative side effects, including skin irritation, rashes and allergy are possible. In Unani system of medicine, various topical single medications and compound formulations, are available. Keeping in view all above facts, a topical Unani formulation comprising Katira, Booraq with Sirka has been selected from Al-Qanun fi Tibb, and the present study has been designed.
 
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