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CTRI Number  CTRI/2024/02/063053 [Registered on: 22/02/2024] Trial Registered Prospectively
Last Modified On: 06/12/2024
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   Evaluation of the efficacy and safety of topical application of polyherbal unani formulation in the management of Melasma 
Scientific Title of Study   Evaluation of the efficacy and safety of topical application of Tukhm-e-Turb and Tukhm-e-Jarjir in the management of Kalf (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  Faiza Hussain 
Designation  MD scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  7582921969  
Fax    
Email  faizahusain19@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Anzar Husain 
Designation  Professor  
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital  
Address  Department of Amrze Jild Wa Tazeeniyat, Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  7879552440  
Fax    
Email  mohdanzar878@gmail.com  
 
Details of Contact Person
Public Query  
Name  Faiza Hussain 
Designation  MD scholar 
Affiliation  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh

Bhopal
MADHYA PRADESH
462003
India 
Phone  7582921969  
Fax    
Email  faizahusain19@gmail.com  
 
Source of Monetary or Material Support  
Hakim Sayed ziaul Hasan Government Unani Medical College and Hospital and Madhya Pradesh Medical Science University Jabalpur 
 
Primary Sponsor  
Name  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital 
Address  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh  
Type of Sponsor  Government 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 Faiza Hussain  Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital   OPD No.5 Department of Amraze Jild wa Tazeeniyat Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar Bypass Road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH 		 7582921969

faizahusain19@gmaill.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Syed Ziaul Hasan Government Unani Medical College   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L80-L99||Other disorders of the skin and subcutaneous tissue,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Azelaic acid 10% cream  Marketed formulation of Azelaic acid 10% cream. provided to the patient to apply locally on the affected part of the face daily at bedtime for 6 weeks. 
Intervention  Ṭilᾱ᾿(liniment) which consists of fine powder of Tukme Turb (seeds of Raphanus sativus) and Tukhme Jarjir (seeds of Eruca sativa Miller)  A topical Unani formulation Ṭilᾱ᾿(liniment) which consists of fine powder of Tukme Turb (seeds of Raphanus sativus) and Tukhme Jarjir (seeds of Eruca sativa Miller) in equal proportion. This powder will be further mixed with water in the required amount to make a thin homogenous paste. patients will be advised to do hot fomentation with water over the affected part of the face for 5 minutes. then patient will be advised to make the paste of the powder at the time of application of Unani formulation in the form of Ṭilá¾± (liniment) and apply daily at bedtime for 6 weeks. 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  1 Clinically diagnosed patients of Kalf (Melasma) by wood’s lamp examination.
2 Patients with Fitzpatrick skin types III, IV and V
3 Patients of all sexes.
4 Patients who are willing to sign the written consent form prior to participation in the study. 
 
ExclusionCriteria 
Details  1 Pregnant and lactating women.
2 Patients having used any cosmetic depigmenting agent within 2 weeks prior to inclusion in the study.
3 Female on oral contraceptives and hormone therapy at the time of study.
4 Patients having used topical or systemic corticosteroid within 1 month prior to inclusion in the study.
5 Patients having history of laser treatment or dermabrasion or deep facial peels within the past 3 months.
6 Patients who have a known history or clinically relevant allergy, to any study medication components.
7 Patients who have a known history of renal insufficiency, severe liver or heart diseases, neurological disorders, malignancy, HIV infection, AIDS, etc.
8 Patients unlikely to comply with the study protocol. 
 
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 
• modified Melasma Area Severity Index (mMASI)
• Patient Global
Assessment (PtGA)  		 Baseline,2nd week, 4th week and 6th week 
 
Secondary Outcome  
Outcome  TimePoints 
Melasma quality of life scale (MELASQoL)  Baseline and 6th week 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
Final Enrollment numbers achieved (Total)= "40"
Final Enrollment numbers achieved (India)="40" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)
Modification(s)  		 06/04/2024 
Date of Study Completion (India) 10/03/2025 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) Date Missing 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)   Not Applicable 
Recruitment Status of Trial (India)  Completed 
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
Modification(s)  
Kalf (Melasma) is an acquired hyper melanotic condition that generally strikes women and is characterized by symmetrical light brown to grey brown macules or patches that form over the cheeks, around the eyes, at chin and across the forehead. As classified according to the location of the pigment, three types of melasma exist, namely, epidermal, dermal, and mixed. According to Unani system of medicine, Kalf commonly called as Jhae’en which develops by burnt blood that leaks from capillaries and pools up underneath the skin .
Despite the fact that melasma can affect people of all sexes and skin types, it is most prevalent among adult women with darker skin tones aged between 27 and 57 years. The prevalence of melasma is 1% in the general population and as high as 50% in high-risk populations. It varies from 0.25% to 4% in Southeast Asia. It is the most typical hyper pigmentary disorder among Indians, and the female-to-male ratio is around 4:1.
Due to the fact that melasma mostly affects the face, which causes patients to feel distressed, it has a negative impact on the patients’ quality of life, hurting their psychological and emotional well-being as well as social interactions. Sometimes this might lead the patient to feel shame, frustration, embarrassment, low self-esteem, and demotivation.
Regardless of the numerous treatment options available to treat melasma, it remains a medical concern. As it is recalcitrant to available treatments.
Kalf (Melasma) is treated in the Unani system of medicine with time-tested formulations that possess properties like Muṣaffῑ-i-Dam, Ghassᾱl, Moḥallil, Jᾱlῑ, and Mohassin e Lawn, which are quite effective and have no or fewer adverse effects. Therefore, there is a need to validate the Unani treatment on contemporary, scientifically validated, and reliable parameters. In addition to this, it is cost-effective, economical, and, by far, accessible and safe to use
 
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