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CTRI Number  CTRI/2021/09/036582 [Registered on: 16/09/2021] Trial Registered Prospectively
Last Modified On: 15/09/2021
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Evaluating efficacy of a Unani formulation in melasma. 
Scientific Title of Study   A Randomized, Parallel Group, Open Label, Active Controlled Clinical Study to Evaluate the Safety and Efficacy of a Unani Formulation in 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  Tatheer fatma 
Designation  PG scholar 
Affiliation  National Research institute of Unani medicine for skin disorders 
Address  Department of Moalajat, National Research institute of Unani medicine for skin disorders, A G colony road, opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  7670967665  
Fax    
Email  dr.tatheer.khan2008@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Mohammad Nawab 
Designation  Reader 
Affiliation  National Research institute of Unani medicine for skin disorders 
Address  Department of Moalajat, National Research institute of Unani medicine for skin disorders, A G colony road, opposite ESI Hospital, Erragadda, Hyderabad 500038

Hyderabad
TELANGANA
500038
India 
Phone  8100992044  
Fax    
Email  ccrumnawab@gmail.com  
 
Details of Contact Person
Public Query  
Name  Tatheer fatma 
Designation  PG scholar 
Affiliation  National Research institute of Unani medicine for skin disorders 
Address  Department of Moalajat, National Research institute of Unani medicine for skin disorders, A G colony road, opposite ESI Hospital, Erragadda, Hyderabad 500038.

Hyderabad
TELANGANA
500038
India 
Phone  7670967665  
Fax    
Email  dr.tatheer.khan2008@gmail.com  
 
Source of Monetary or Material Support  
National Research institute of Unani medicine for skin disorders 
 
Primary Sponsor  
Name  National Research institute of Unani medicine for skin disorders 
Address  A G colony road, opposite ESI Hospital, Erragadda, Hyderabad 500038 
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 
Tatheer fatma  National Research institute of Unani medicine for skin disorders  OPD of Department of Moalajat, New OPD block, National Research institute of Unani medicine for skin disorders A G colony road, opposite ESI Hospital, Erragadda, Hyderabad 500038.
Hyderabad
TELANGANA 		 7670967665

dr.tatheer.khan2008@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics committee, NRIUMSD, Hyderabad  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  Group A:A Unani formulation  Participants will be advised to apply zimad of a Unani formulation on the affected area at night daily.  
Comparator Agent  Group B:Hydroquinone 4%  Hydroquinone 4% cream will be apply locally on the affected area daily at night .  
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  55.00 Year(s)
Gender  Both 
Details  Participant having single or multiple, symmetrical
or asymmetrical brown macules on face, cheeks, nose, forehead, upper lip and chin.
 
 
ExclusionCriteria 
Details  a) Women who are pregnant, and lactating.
b) Participant aged <18 years or >55 years.
c) Significant cardiovascular/ pulmonary/ hepatorenal dysfunction.
d) Known case of diabetes mellitus, HIV/ AIDS and malignancy.
e) Those unwilling to come for regular follow-up for the entire duration of the study and any patients considered not eligible according to the investigator’s discretion during the study. 
 
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 
25% reduction in MASI score from the baseline after 8 weeks of treatment.   8 Weeks 
 
Secondary Outcome  
Outcome  TimePoints 
improvement in quality of life.  8 weeks 
 
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)   20/09/2021 
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 Applicable 
Recruitment Status of Trial (India)  Not Yet Recruiting 
Publication Details   Outcome of the study will be published in the form of thesis and research article. 
Individual Participant Data (IPD) Sharing Statement

Will individual participant data (IPD) be shared publicly (including data dictionaries)?  

Response - NO
Brief Summary   Kalaf (Melasma) is a common acquired disorder of hyperpigmentation characterized by irregular light to dark brown macules on the sun exposed area of the face. The prevalence of melasma ranges from 8.8% to 40%.It affects all age population but mostly common in 21-44 years age group. Melasma affects all races especially Hispanics, Asians, Africans, Arab and mostly affects person with darker skin type.  Exact cause of melasma is unknown, but various risk factors that play an important role to aggravate melasma i.e. uncontrolled sun exposure, pregnancy, hormonal influences, darker phenotype, genetic factors. It produces considerable impact on the patient’s quality of life. It further produces psychological upset in the form of low self-esteem, nervousness, irritation, depression and anxiety. Melasma is a curable disease but it requires long term treatment. It has been observed that recurrence after cessation of treatment is a most common problem. Conventional therapy such as application of hydroquinone produces various side effects like dermatitis, post inflammatory pigmentation. Nowadays cosmetics having metal which are very dangerous to the health are being used. Hence it is felt that there is a need to search for safe and effective treatment for melasma. 
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