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CTRI Number  CTRI/2024/02/062478 [Registered on: 09/02/2024] Trial Registered Prospectively
Last Modified On: 28/01/2025
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   Clinical study to evaluate the effect of a unani formulation of tila in melasma 
Scientific Title of Study   A clinical study of kalaf(melasma) with therapeutic evaluation of tila tukhm-e-jarjir (Eruca sativa linn.)and tukhm-e-turb(Raphanus sativus var.longipinnatus) in its management ; A block randomised single blind standard 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  Dr Mohammad Sheeraz Mushtaque Ahmed 
Designation  Reader, Dept. of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine 
Address  OPD No.1 ,Ground floor,Department of Moalajat, Regional Research Institute of Unani Medicine Kashmir University Naseem Bagh Srinagar J&K

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  sheeraz.rrium@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Mohammad Sheeraz Mushtaque Ahmed 
Designation  Reader, Dept. of Moalajat 
Affiliation  Regional Research Institute of Unani Medicine 
Address  OPD NO.1 , Ground Floor, Department of Moalajat, Regional Research Institute of Unani Medicine Kashmir University Naseem Bagh Srinagar J&K

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9797750472  
Fax    
Email  sheeraz.rrium@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Faheem Akhtar 
Designation  PG Scholar 
Affiliation  Regional Research Institute of Unani Medicine 
Address  OPD No.1, Ground Floor, Department of Moalajat, Regional Research Institute of Unani Medicine Kashmir University Naseem Bagh Srinagar J&K

Srinagar
JAMMU & KASHMIR
190006
India 
Phone  9971989319  
Fax    
Email  faheemakhtar99719@gmail.com  
 
Source of Monetary or Material Support  
Central Council for Research in Unani Medicine New Delhi 
 
Primary Sponsor  
Name  Central Council for Research in Unani Medicine New Delhi 
Address  Regional Research Institute of Unani Medicine(RRIUM) , University of Kashmir,Srinagar, CCRUM New Delhi 
Type of Sponsor  Research institution 
 
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 Mohammad Sheeraz Mushtaque Ahmed  Regional Research Institute of Unani Medicine Srinagar  Moalijat OPD-1, Ground Floor Department of Moalijat, RRIUM, Naseembagh Campus University of Kashmir Hazratbal
Srinagar
JAMMU & KASHMIR 
9797750472

sheeraz.rrium@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee(IEC) for Biomedical Research,RRIUM  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  Kojic acid 2% Cream  Kojic acid 2% cream will be given to the patient for application on affected part for 15 minutes at bed time for the period of 28 days. 
Intervention  Tila (Liniment)  Tila prepared from Tukhm-e-jarjir(Eruca Sativa linn.) and Tukhm-e-Turb(Raphanus sativus var.Longipinnatus) along with sirka angoori will be given to the patient for application to the affected part for 15 minutes at bed time for a period of 28 days 
 
Inclusion Criteria  
Age From  18.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Clinically diagnosed patients of Kalaf.
Patients irrespective of gender.
Patients in the age group of 18 to 60 years 
 
ExclusionCriteria 
Details  Known cases of skin allergy or sensitivity as revealed by history and clinical examintaion.
Pregnant and Lactating Women and Patients on Oral Contraceptives.
Diseases requiring long term treatments (Including Uncontrolled Diabetes Mellitus, Cardiovascular Diseases, Chronic Renal Diseases, Chronic Liver Diseases) Diagnosed by History of patient and Clinical Examination.
Unwillingness or inability to fill the protocol.
Patients who fail to give the informed consent. 
 
Method of Generating Random Sequence   Permuted block randomization, fixed 
Method of Concealment   On-site computer system 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Brown and Black Pigmentation measure by physicians assessment scale.
Irregular, sharp, black and brown hyperpigmented macules measure by Likert Scale. 
day 0, day 7, day 14 , day 21 and day 29 
 
Secondary Outcome  
Outcome  TimePoints 
photographs of the hyperpigmented macules or lesion. Identity and also the photographs clicked will be placed in such a manner that his or her eyes are not revealed and hence the confidentiality will be maintained.
Melasma Area Severity Index (MASI) 
day 0 and day 29 
 
Target Sample Size   Total Sample Size="48"
Sample Size from India="48" 
Final Enrollment numbers achieved (Total)= "48"
Final Enrollment numbers achieved (India)="48" 
Phase of Trial   Phase 2 
Date of First Enrollment (India)   15/02/2024 
Date of Study Completion (India) 28/11/2024 
Date of First Enrollment (Global)  Date Missing 
Date of Study Completion (Global) 28/11/2024 
Estimated Duration of Trial   Years="1"
Months="0"
Days="0" 
Recruitment Status of Trial (Global)
Modification(s)  
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  
Kalaf (Chloasma or Melasma ), is a sharply, irregular, bordered, hyperpigmented area most
often on the forehead and cheeks, and rarely on the upper chest and extremities, the pattern
almost forming a mask. The color is usually light brown but darkens with sun exposure. The
disorder is slowly progressive and chronic and the disease mainly occurs in summer.
The main etiology is not known but some cases are seen in during pregnancy (“mask of
pregnancy”) or with longtime illness. Women on contraceptive pills also develop chloasma or
Melasma. Incidence of this disorder in pregnant lady is almost 60 percent and women on
contraceptive pills is almost 30 percent.Mostly occurs in age group between 30 to 55 years
and rarely in case of minor and after menopause.
Melasma word is derived from Greek word “Melas” meaning black. Its prevalence is high
in individuals of Asia, Latin America and people of Hispanic origin and in Fitzpatrick skin
type 3-5 .Its prevalence in india is almost 0.25% to 4% and skin disorders are very well recognised
since Greek Arabic Period.
According to Classical Unani Books, the main cause of Kalaf is accumulation of
Sauda(Black Bile) under the layer of skin.9 Kalaf Or Jhhaien Or Melasma is almost
described in all Classical Books of Unani and Council‟s authenticated Books like Al-
Moalajat-al-Buqratiya, Al-Havi etc.
In modern system of medicine, Melasma is treated by various ways like topicals creams e.g
Kojic Acid, Hydroquinone, Azelaic Acid or by oral drugs like Glutathione, Tanexamic Acid
etc or with combination of oral and topical drugs.11 Some therapies are also available for
Melasma like micro needle insertion with some chemicals or chemical peelings or some
Lasers etc. These treatments have some adverse effects like itching, redness, irritation,
allergy from topical creams.The effect of this disease on general health is nil. But it creates
problems in social life. This disease has negative impact on life. Melasma is very frustrating
disorder to treat and one with significant psychosocial implications. Keeping in view of the
above facts, the present study entitled
“A Clinical Study Of Kalaf (Melasma) With Therapeutic Evaluation Of Tila Tukhm-e -
Jarjir(Eruca Sativa linn.) And Tukhm-e-Turb(Raphanus sativus var.Longipinnatus) in its
Management ; A Block Randomised, single blind, Standard Control Study”.
 
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