FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2025/06/089523 [Registered on: 25/06/2025] Trial Registered Prospectively
Last Modified On: 25/06/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) [Topical unani formulation ]  
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Treatment of melasma with topical unani medicine.  
Scientific Title of Study   Therapeutic assessment of topical Husn-i-Yusuf with Rogan-i-Chambeli in managing Kalaf (melasma) - A randomized standard controlled trial.  
Trial Acronym  NO 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Javeriya Azeem 
Designation  Pg Scholar 
Affiliation  Luqman unani medical college and research center 
Address  Luqman unani medical college hospital and research center 12 naubag opp star function hall vijaypura karnataka

Bijapur
KARNATAKA
586101
India 
Phone  8792366335  
Fax    
Email  juweriyaazeem@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr dafedar abdur rehman 
Designation  Associate professor 
Affiliation  Luqman unani medical college and research center 
Address  Luqman unani medical college hospital and research center 12 naubag opp star function hall vijaypura karnataka

Bijapur
KARNATAKA
585101
India 
Phone  9032786832  
Fax    
Email  drdafedar1@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr saba mamdapur 
Designation  Professor 
Affiliation  Luqman unani medical college and research center 
Address  Luqman unani medical college hospital and research center 12 naubag opp star function hall vijaypura karnataka

Bijapur
KARNATAKA
585101
India 
Phone  9611497816  
Fax    
Email  dr.sabamamdapur@gmail.com  
 
Source of Monetary or Material Support  
Luqman unani medical college hospital and research center 12 naubag opp star function hall bijapur 586101 karnataka india 
 
Primary Sponsor  
Name  Luqmqn unani medical college hospital and research center 
Address  Luqmqn unani medical college hospital and research center vijayapur karnataka 586101  
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 Javeriya Azeem  Luqman unani hospital   1st OPD of department of moalijat Luqman unani hospital 12 naubag opp star function hall bijapur 586101 karnataka india
Bijapur
KARNATAKA 
8792366335

juweriyaazeem@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 Reseach  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L811||Chloasma,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Husn-i-Yusuf with Rogan-i-Chambeli   Husn-i-yusuf will be finely ground and sieved to create a powder which will then be mixed with clarified Roghan-i-chambeli until a consistent paste Application Method Applied topically Dosage Apply a sufficient quantity 1-2g twice daily Duration of Application 20 minutes Follow-up at the Baseline 2nd 4th 6th and 8th weeks  
Comparator Agent  Hydroquinone 4%  Formulation Cream Application Method Applied topically Duration of Application 20 minutes Dosage Apply a sufficient quantity twice daily Follow-up Scheduled at the Baseline 2nd 4th 6th and 8th weeks  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Both men and women are eligible
Partipants aged between 18 to 50 years
Individuals clinically diagnosed with melasma
Participants able and willing to comprehend and adhere to the study protocol through out its duration

 
 
ExclusionCriteria 
Details  Pregnant or breast feeding women based on history
Individuals with a history of current presence of skin allergies or allergic reactions to hydroquinone
Individualss with a history of current presence of severe diseases including immunological conditions like HIV existing malignancies diabetes mellitus hypertension etc
participants who have used any topical or systemic treatments for scalp conditions within 15 daysprior to the baseline assessment
patients with a history of chemical peels and facial laser treatments within the past 9 months as well as those who have used sun protection creams 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Change in Melasma Area and Severity Index mMASI score  baseline 2nd 4th 6th and 8th weeks 
 
Secondary Outcome  
Outcome  TimePoints 
Change in dermatology life quality index DLQI
 
Baseline and after treatment 
Change in IGA for melasma severity on 100mm VAS score  Baseline and after treatment 
 
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)   07/07/2027 
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 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 - 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 [juweriyaazeem@gmail.com].

  6. For how long will this data be available start date provided 02-01-2028 and end date provided 05-01-2032?
    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 - nil
Brief Summary  
Melasma (Kalaf)stands out as a significant and complex form of acquired hyperpigmentation, often encountered in general dermatology practices. Particularly in the Indian demographic, it emerges as the most prevalent pigmentary issue, typically affecting individuals in the age range of 30 to 40 years. (1,2) Melasma is a significant cosmetic issue that has widespread implications worldwide. (3) The precise prevalence of melasma in South Asia is still unclear, with estimates varying between 0.25% to 4%. In India, melasma is among the most common hyperpigmentary disorders, although specific prevalence figures differ among different regions. (4) Melasma affects approximately 5 to 6 million people in the United States alone, and its incidence is even greater globally. While it is more commonly seen in females, males make up about 10% of cases and demonstrate similar clinicopathological characteristics. (1,5) While melasma can affect individuals of all racial and ethnic backgrounds, it is more prevalent among those with darker skin tones, specifically skin types 4 to 5. This is especially true for Hispanic, Asian, and African populations living in areas with elevated levels of ultraviolet (UV) radiation. (4) Melasma typically shows a male-to-female ratio of 1:10, with most cases occurring during the third or fourth decade of life. However, lesions may also appear after the age of 40 or 50 in 14% and 6% of cases, respectively. (6) Melasma appears on the facial areas exposed to the sun, predominantly impacting the forehead, cheeks, temples, and jawline. It presents as symmetrically distributed dark brown patches, often with clear boundaries. The forehead, cheeks, upper lip, nose, and chin are frequently affected. (7,8,9) Clinically, melasma presents as irregular patches of brown, gray, or blue macules without signs of redness or irritation. (7,10) While it’s commonly linked to hormonal factors like oral contraceptive use or pregnancy, it can also occur in both men and women without hormonal influence. Previous understandings attributed hyperpigmentation solely to melanin in the epidermis, but recent research suggests that an increased quantity of melanocytes may also play a role in the observed epidermal hyperpigmentation in melasma. ((3,8,11,12,1314) Managing melasma is challenging and requires a prolonged treatment plan. Traditionally, there are several topical therapy options, such as hydroquinone, kojic acid, and azelaic acid, which are used as hypo-pigmenting agents. (15) Hydroquinone alone and triple combination cream (consisting of hydroquinone, tretinoin, and corticosteroid) are widely regarded as the most effective and established treatments for melasma. Chemical peels, laser, and light-based therapies are alternative options, but they carry a higher risk of adverse effects compared to topical treatments. (16) Traditional treatments for melasma carry the risk of adverse reactions. Hydroquinone, a frequently utilized agent, can result in dose and time-dependent effects like erythema, stinging, and paradoxical post-inflammatory hyper-melanosis. Concentrations of hydroquinone exceeding 2% may induce "confetti-like" depigmentation, while prolonged usage can lead to ochronosis. Topical corticosteroids, employed to alleviate irritation, may cause skin lightening and, when used extensively, can lead to skin atrophy and other complications. (17,18) In response to the limitations of conventional treatments for melasma, there is a growing interest in exploring alternative therapeutic options. Traditional medicine systems like Unani medicine offer potential remedies for melasma by drawing upon ancient healing practices. The primary aim of this study was to find a safe and effective treatment for melasma. Specifically, it sought to evaluate the safety and efficacy of a topical formulation combining Husn-i-Yusuf and Rogan-i- chambeli (19) through an open label randomized controlled trial titled "Therapeutic assessment of topical Husn-i-Yusuf with Rogan-i-Chambeli in managing Kalaf (melasma) – A randomized standard controlled trial."
 
Close