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CTRI Number  CTRI/2023/09/057430 [Registered on: 11/09/2023] Trial Registered Prospectively
Last Modified On: 11/09/2023
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Preventive 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Clinical Research Project to Evaluate Effects and Fruitfulness of Unani Medicine in Treatment of Melasma (Hindi: Jhayeen) 
Scientific Title of Study   Comparative Clinical Evaluation of the Efficacy of Topical Unani Formulations in the Management of Kalaf (Melasma) 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Nushrat Jahan 
Designation  MD Scholar 
Affiliation  Jamia Hamdard 
Address  Room No.104, Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar,Delhi

South
DELHI
110062
India 
Phone  9278817191  
Fax    
Email  NushratJahan@outlook.in  
 
Details of Contact Person
Scientific Query  
Name  Dr Yasmeen Shamsi 
Designation  Professor 
Affiliation  Jamia Hamdard 
Address  Room No.104, Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar,Delhi

South
DELHI
110062
India 
Phone  8750040776  
Fax    
Email  yshamsi@jamiahamdard.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Yasmeen Shamsi 
Designation  Professor 
Affiliation  Jamia Hamdard 
Address  Room No.104, Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar,Delhi

South
DELHI
110062
India 
Phone  8750040776  
Fax    
Email  yshamsi@jamiahamdard.ac.in  
 
Source of Monetary or Material Support  
Department of Moalajat, School of Unani Medical Education and Reserarch, Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar, Delhi-110062 
Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar,Delhi-110062 
OPDs of Majeedia Unani Hospital, Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar,Delhi-110062 
 
Primary Sponsor  
Name  Jamia Hamdard (Deemed to be university) 
Address  Mehrauli - Badarpur Rd, near Batra Hospital, Block D, Hamdard Nagar, New Delhi, Delhi 110062 
Type of Sponsor  Other [Jamia Hamdard (Deemed to be university)] 
 
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 Nushrat Jahan  Majeedia Unani Hospital  OPD No.11, Majeedia Unani Hospital, Department of Moalajat, School of Unani Medical Education and Research, Jamia Hamdard, Mehrauli Badarpur Road, Hamdard Nagar, Delhi - 110062
South
DELHI 		 9278817191

NushratJahan@outlook.in 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Jamia Hamdard Institute Ethics Committee  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  Kalaf Cream  It is planned to develop a Cream Form of Tila-e-Kalaf by converting it into a semisolid cream with anticipation to improve its efficacy, safety, and better patients’ compliance. Tila-e-Kalf will be converted into cream form in the Department of Pharmaceutical , School of Pharmaceutical Education and Research (SPER), Jamia Hamdard, New Delhi.  
Comparator Agent  Tila-e-Kalaf  Tila-e-Kalf is a Unani pharmacopeial formulation, it is composed of masoor (lens culinaris) and badam-e-Talkh (prunus amygdalus)  in equal proportion which is  grinded and powdered. The powder is mixed with joshanda-e-anjeer (ficus carica) for making paste. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients of all genders, belonging to 18 to 60 years of age and willing to participate in the trial voluntarily.
Clinically diagnosed patients of epidermal melasma using Wood’s lamp (340-400 nm).
Patients willing to sign the informed consent form. 
 
ExclusionCriteria 
Details  Pregnant and lactating women.
Female patient using oral contraceptives.
Patients having field work jobs.
Patients with drug or alcohol addiction.
Patients with uncontrolled diabetes mellitus, renal disorders, severe liver, and heart diseases.
Patients have used bleaching creams or topical steroid creams such as Azeliac acid, tretinoin and hydroquinone in the past 4 weeks before entering in the study.
Patients who have undergone any laser therapies and chemical peeling or consuming photosensitizing substances in past 4 weeks.
Patients having thyroid disorders. 
 
Method of Generating Random Sequence   Random Number Table 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Reduction in MASI Scale
Reduction in Melasma QoL Index
Reduction in PGA 		 1st,14th,28th,42nd,56th 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
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 
Date of First Enrollment (India)   21/09/2023 
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="2"
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 - NO
Brief Summary  
Although, melasma does not cause any major health related complications, it severely affects social life as well as emotional well-being of the patients. Patients commonly report feelings of dissatisfaction, low self-esteem, shame, anhedonia, and the lack of motivation to go out. Since melasma significantly affects psychosocial well-being due to the ugly patchiness of skin; therefore, the treatment of melasma in terms of its psychological complications is of particular importance. 
Management of melasma is a substantial challenge. Topical, oral, procedural and combination treatments are used as conventional treatment of melasma. These are aimed at various aspects of the pathogenesis of melasma including photodamage, inflammation, vascularity, and pigmentation. Bleaching agents like phenolic compounds, hydroquinone, and its combinations like monobenzyl ether of hydroquinone (MBEH), Azealiac acid, combination with tretinoin (retinoic acid), kojic acid and hydrocortisone are used in topical ointments. However, all of these are associated with skin irritation, redness and more severe complications like epidermal atrophy, acne (seen with corticosteroids), exogenous ochronosis (seen with Hydroquinone) etc. More severe reactions like burning, itching, dryness, folliculitis, skin hypopigmentation, allergic contact dermatitis and secondary infection are also reported. Oral medications like Tranexamic Acid are known to cause abdominal bloating, menstrual irregularities, headache, and deep venous thrombosis. 
Laser therapy, chemical peeling, micro needling, and cellular bio-stimulation by radiofrequency are popular procedural treatment of melasma. Although, procedural treatments have demonstrated a better efficacy in the long run, they are associated with adverse events such as burns, post inflammatory pigment alteration, peeling of skin etc. A high rate of recurrence, even after successful treatment is an important concern.
Keeping in mind the above facts, a need is felt where different and effective therapeutic option can be provided for the treatment of melasma without producing side effect. Unani medicines have been proved to be effective in curing various dermatological diseases. Tila-e Kalaf is an Unani Pharmacopoeial formulation, it is composed of Masoor (Lens culinaris) and Badam Talkh (Prunus amygdalus), and Anjeer (Ficus carica). The paste of Tila-e Kalaf is prepared in the following steps:
1. Masoor (Lens culinaris) and Badam Talkh (Prunus amygdalus) are grinded and powdered separately and then mixed together in equal proportions.
2. The Ficus carica (Anjeer) is boiled to prepare its Joshānda (decoction).
3. The powder of Masoor and Badam Talkh is then mixed in Joshānda Anjeer for making paste and to be applied on face once daily.

In the year 2020, in the Dept. of Moalajat, Jamia Hamdard, New Delhi, a randomized standard controlled clinical study was conducted to evaluate the efficacy and safety of Unani formulation Tila-e-Kalaf in the treatment of Melasma.  In the said study, the test group participants were treated topically with Tila-e-Kalaf, whereas the controlled group patients were treated with local application of standard topical formulation containing tretinoin 0.05%, hydroquinone 4.0%, and fluocinolone acetonide 0.01% gel. Treatment with Tila-e-Kalaf in test group was found more effective without producing any significant side effects as compared to the control group. However, in the test group, the patient’s compliance was not quite as good as it could have been. A considerable number of patients faced inconvenience in applying Tila-e-Kalaf due to its non-sticky stuff and coarse particles, and due to cumbersome method of preparation. So, keeping this in view, it is planned to redesign the dosage form of Tila-e-Kalaf by converting it into a semisolid cream in anticipation to improve its efficacy and better patients’ compliance.
Therefore, in the present study, Pharmacopeial formulation Tila-e-Kalaf will be taken as a control to compare the efficacy of Kalaf cream in the management of Kalaf (Melasma). 
 
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