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CTRI Number  CTRI/2022/07/044251 [Registered on: 22/07/2022] Trial Registered Prospectively
Last Modified On: 21/07/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Unani 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Effect of Unani formulation in Dark Spots on face. 
Scientific Title of Study   Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma) - A Randomized Controlled Trial. 
Trial Acronym   
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Wasima Swaleha 
Designation  PG Scholar 
Affiliation  Government Unani Medical College and Hospital 
Address  Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore
Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore
Bangalore
KARNATAKA
560079
India 
Phone  8088260712  
Fax    
Email  wasimaswaleha36@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Nusrath Fathima 
Designation  Assistant Proffesor 
Affiliation  Government Unani Medical College and Hospital 
Address  Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore
Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore
Bangalore
KARNATAKA
560079
India 
Phone  7022317892  
Fax    
Email  drnusrathfarooque@rediffmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Wasima Swaleha 
Designation  PG Scholar 
Affiliation  Government Unani Medical College and Hospital 
Address  Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore
Government Unani Medical College and Hospital Siddiaiah puranik road Basaweshwar nagar bangalore
Bangalore
KARNATAKA
560006
India 
Phone  8088260712  
Fax    
Email  wasimaswaleha36@gmail.com  
 
Source of Monetary or Material Support  
Goverrment Unani Medical College And Hospital bangalore 
 
Primary Sponsor  
Name  Goverrment Unani Medical College And Hospital 
Address  Dept. of Moalajat, Government Unani Medical College and Hospital, 80 feet Rd, near Pavithra Paradise, Stage 1, Agrahara Dasarahalli, Basaveshwara nagar, Bengaluru-560079 
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 
Dr Wasima Swaleha  Government Unani College and Hospital, Bangalore  33, 80 Feet Ring Rd, Stage 1, KHB Colony, Basaveshwar Nagar, Bengaluru, Karnataka 560079
Bangalore
KARNATAKA 
8088260712

wasimaswaleha36@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Government Unani Medical and Hospital Bangalore  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: L814||Other melanin hyperpigmentation, (2) ICD-10 Condition: L814||Other melanin hyperpigmentation,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Intervention  Efficacy of Unani single drug Rewandchini   Safoof of Rewandchini 2-3 gms with half teaspoon of asl prepared as zimad for local application in clinical trail on cases of kalaf melasma once in night for 20 minutes and then washed with normal water for 6 weeks 
Comparator Agent  hydroquinone 2 percent  Local application of hydroquinone 2 percent in clinical trail on cases of kalaf melasma once in night for 20 minutes and then washed with normal water for 6 weeks 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  50.00 Year(s)
Gender  Both 
Details  1 Clinical patients of Kalaf (Melasma)
2 Patients of either sex
3 Patients between 18-50yrs of age
4 Patients with Fitzpatrick skin type III- type V
5 Patient m-MASI score up to 3 (Moderate/Marked) in darkness and ≤ 49% in Area
6 Duration of Melasma ≤ 3yrs
7 Willingness to participate in the study and follow the instructions
 
 
ExclusionCriteria 
Details  1 Patients with any systemic illness and malignancies
2 Patients on contraceptive pills
3 Skin sensitivity
4 Severe cases of Melasma (m-MASI score >50%)
5 Pregnancy/ Lactating women
6 Hormonal replacement therapy
7 Topical bleaching agents for at least 1month or chemical peeling or laser at least 4months before the start of the study 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Sequentially numbered, sealed, opaque envelopes 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
improvement in kalaf melasma as per mMASI score and PGA score  improvement in kalaf melasma as per mMASI score and PGA score on 7th 14th 21st 28th 35th 42nd day 
 
Secondary Outcome  
Outcome  TimePoints 
Nil  Nil 
 
Target Sample Size   Total Sample Size="37"
Sample Size from India="37" 
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)   25/07/2022 
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   Nil 
Individual Participant Data (IPD) Sharing Statement

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

Response - NO
Brief Summary  

 

Melasma is common hypermelanosis that typically occurs on sun-exposed areas in the face. The overall prevalence of Melasma in women varies by geography and population between 1.5% and 33.3%. The estimated prevalence of melasma in pregnant women is up to 70%. The prevalence of melasma in men as suggested in one simple survey is approximately 20%. It is a cosmetic issue that sometimes cause great psychological suffering. As per one study, which showed that melasma associated with significant impact on health-related quality of life. It is characterized by sharply demarcated, blotchy, brown maculae, usually symmetrical on the cheeks, forehead, sometimes on the upper lip and neck. According to Unani system factors affecting kalaf  includes frequent exposure to excess abnormal external heat;  Dam-e-Muharraq (charred blood), Sauda-e-Muharraq (charred melancholic blood),  Ghiza-e-Kaseef (indigestible food), constant local pressure, pregnancy, liver disease i.e. Du’f al-kabid (liver atony) and Sughàr al-kabid. Although Melasma is asymptomatic it is disfiguring skin disease that has a negative impact on life and the self-esteem of effected individuals and causes distress in the patients as it mainly affects the face. It affects their psychological and emotional wellbeing and often feel bothered, frustrated, embarrassed, and depressed about their skin appearance.

The physician described various regimenal and pharmacotherapies for the management of Melasma in detail. The Pharmacological action of zimad in present study exhibits: Jali (detergent), qabiz (astringent), Qasir (Scaling), Ghassal (irrigator), Mubassir (vesicant), Muhammir (rubifecient), Raade-Mawaad (divergent), Mughazzi (nutrient), muhalil-e-awram (anti-inflammatory), antioxidant, antimicrobial, dafa-e-quba (antifungal), mana-e-sartan (anticancer), mana-e-qurooh (antiulcer) properties.

Therefore a clinical trial entitled ’Efficacy of Rewandchini with Asl as Zimad in Kalaf (Melasma) - A Randomized controlled trial’ is contemplated to evaluate the efficacy of rewandchini with Asl with the objective of improvement in skin lesions and to improve the quality of life of the sufferers of Melasma.


 
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