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CTRI Number  CTRI/2025/09/094063 [Registered on: 01/09/2025] Trial Registered Prospectively
Last Modified On: 01/09/2025
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Medical Device
Unani 
Study Design  Randomized, Parallel Group, Multiple Arm Trial 
Public Title of Study   Evaluation of efficacy of Polyherbal Formulation in the Management of Melasma. 
Scientific Title of Study   Evaluation of efficacy and safety of Unani formulation in the management of Kalf (Melasma): A Randomized Controlled Study. 
Trial Acronym  Nil 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Yougshi Ilahi 
Designation  PG 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
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh
Bhopal
MADHYA PRADESH
462003
India 
Phone  9755316486  
Fax    
Email  yougshi0512@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Mohd Rizwan 
Designation  Lecturer 
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
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus Kolar bypass road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India 
Phone  7828550209  
Fax    
Email  mohddr@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Yougshi Ilahi 
Designation  P.G. 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
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Ayush Campus kolar bypass road Bhopal Madhya Pradesh 462003
Bhopal
MADHYA PRADESH
462003
India 
Phone  9755316486  
Fax    
Email  yougshi0512@gmail.com  
 
Source of Monetary or Material Support  
Hakim Syed Ziaul Hasan Government Unani Medical College and Hospital Bhopal Madhya Pradesh Medical Science University Jabalpur 482003 Madhya Pradesh India 
 
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 
Yougshi Ilahi  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
Bhopal
MADHYA PRADESH 
9755316486

yougshi0512@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee Hakim Sayed Ziaul Hasan Government Unani Medical College And Hospital  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 
Comparator Agent  Glycolic Acid  It will be subjected to topical Glycolic acid 6% cream to the affected area for overnight once a day for 6 weeks. 
Intervention  Zimad (topical Unani Formulation )+ Microdermabrasion  It will be subjected to same Zimad Alsi+ Vinegar (topical Unani formulation) for local application to the affected area for 30 minutes once daily for 6 weeks and Microdermabrasion fortnightly. 
Intervention  Zimad (Topical Unani Formulation)  It will be subjected to same Zimad Alsi + Vinegar topical Unani formulation for local application to the affected area for 30 minutes once daily for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  Patients of all sexes between 18-50 years
Clinically diagnosed patient of Melasma
Female of reproductive age group agree to use acceptable form of birth control during study (except IUCD and hormonal contraception)
Patient willing to sign the informed consent and to complete the study
 
 
ExclusionCriteria 
Details  Pregnant and lactating females
Females using OCP (oral contraceptive pills) IUCD and hormonal contraception
Patient having other skin diseases like acne dermatitis urticaria dermatophytosis
Patients who have a known history or clinically relevant allergy in particular to any component of study medication
Having systemic disorders such as hepatic and renal insufficiency endocrine disorders malignant or premalignant lesions immunodeficiency diseases neurological and cardiac disorders
Patient consuming alcohol or drug abuse
Patient have taken topical or systemic treatment of melasma for last one month
Patient receive any cosmetic procedure such as chemical peel laser ablation FRT or dermabrasion for last 3 months
Not willing to sign informed consent
 
 
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 
1.Melasma severity index
2.Photography
3.Safety evaluation  
1.on day 0, 21, 42
2.on day 0, 42
3.on day 0, 42 
 
Secondary Outcome  
Outcome  TimePoints 
MELASQOL (Melasma Quality of Life Scale)   on Day 0, 42 
 
Target Sample Size   Total Sample Size="51"
Sample Size from India="51" 
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)   15/09/2025 
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="0"
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  

Melasma is a common skin disorder characterized by symmetrical brown patches on the face, especially on the cheeks, forehead, and upper lip. It affects both genders but is more prevalent in women of reproductive age with darker skin tones. The term melasma is derived from the Greek word melas meaning black. In Unani medicine, it is known as Kalf and is thought to be caused by the accumulation of melancholic blood beneath the skin.

While the exact cause of melasma is unclear, contributing factors include genetics, sun exposure, pregnancy, and use of oral contraceptives or photosensitizing drugs. Conventional treatments involve topical agents like hydroquinone and chemical procedures such as peels and lasers. However, these methods often produce inconsistent results and may cause side effects like skin irritation or pigmentation.

This study aims to scientifically evaluate a traditional Unani treatment Zimad made from powdered Alsi and sugarcane vinegar. Patients will be randomly divided into three groups Test Group A will use only Zimad Test Group B will use Zimad with microdermabrasion and the Control Group will use glycolic acid 6 percent cream. The goal is to assess the effectiveness and safety of Unani treatment as a cost effective and side effect free alternative for managing melasma.

 
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