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CTRI Number  CTRI/2022/04/041617 [Registered on: 04/04/2022] Trial Registered Prospectively
Last Modified On: 30/03/2022
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Other (Specify) 
Study Design  Randomized, Parallel Group Trial 
Public Title of Study   Efficacy of Unani drugs on Melasma 
Scientific Title of Study   A Comparative Clinical Study on the Efficacy of Joshanda Haleela Siyah with Tila-e-Tukhm Turb and Tukhm Jarjir vs Tukhm Kharpazah and Aard Baqla 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  Dr Tuba Hanif Zulfar 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraz e Jild Wa Tazeeniyat National Institute of Unani Medicine Kottegepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9987159752  
Fax    
Email  tubazulfar786@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Dr Tuba Hanif Zulfar 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraz e Jild Wa Tazeeniyat National Institute of Unani Medicine Kottegepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9987159752  
Fax    
Email  tubazulfar786@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Dr Mohd Aleemuddin Quamri 
Designation  Professor 
Affiliation  National Institute of Unani Medicine 
Address  Department of Amraz e Jild Wa Tazeeniyat National Institute of Unani Medicine Kottegepalya Magadi Main Road Bengaluru

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Source of Monetary or Material Support  
Room No. 4 Skin OPD National Institute of Unani Medicine Hospital  
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  OPD No 04 Department of Amraze Jild Wa Tazeeniyat National Institute of Unani Medicine Bengaluru 
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 Tuba Hanif Zulfar  Room No. 4 Skin OPD National Institute of Unani Medicine  Room No. 4 Skin OPD National Institute of Unani Medicine Kottigepalya Magadi Main Road Bengaluru 560091
Bangalore
KARNATAKA 
9987159752

tubazulfar786@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee for Biomedical Research  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,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Haleela Siyah Ard Baqla and Tukhme Kharpazah  Haleela Siyah 10g Ard Baqla 5g and Tukhme Kharpazah 5g 10 gm of Haleela Siyah will be soak overnight in 150 ml of water and its Decoction will be drink once in morning before meal for 2 weeks in both Group Prior to the application of Tila Fomentation of hot water to be taken for 10 minutes Then Safoof of Tila Ard Baqla and Tukhme Kharpazah mixed in the normal water and applied on the affected site of face by means of facepack brush for 20 minutes once in a day for 3 weeks in Group B 
Intervention  Haleela Siyah Tukhme Turb and Tukhme Jarjir  Haleela Siyah 10g Tukhme Turb 5g Tukhme Jarjir 5g 10 gm of Haleela Siyah will be soak overnight in 150 ml of water and its Decoction will be drink once in morning before meal for 2 weeks in both Group Prior to the application of Tila Fomentation of hot water to be taken for 10 minutes. Then Safoof of Tilae Tukhme Turb and Tukhme Jarjir mixed in the normal water and applied on the affected site of face by means of facepack brush for 20 minutes once in a day for 3 weeks in Group A 
 
Inclusion Criteria  
Age From  25.00 Year(s)
Age To  60.00 Year(s)
Gender  Both 
Details  Patients with Fitzpatrick Skin phototype 3rd to 6th
Patients m MASI Score up to Marked in Darkness (0-3) and ≤ 49 % in Area
Duration of Melasma ≤ 3 Yrs.
Patient willing for study 
 
ExclusionCriteria 
Details  Pregnant and Lactating women
Patients with systemic disease e.g. Malignancy, Thyroid Dysfunction, CKD, Tuberculosis.
History of any Skin therapies related to Hyperpigmentation
History of Hypersensitivity Reaction with Drugs.
Severe Cases of Melasma 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Case Record Numbers 
Blinding/Masking   Participant Blinded 
Primary Outcome  
Outcome  TimePoints 
Reversal of mMASI, PGA, PtGA, scores
Change in photographic lesion 
28 days 
 
Secondary Outcome  
Outcome  TimePoints 
NA  NA 
 
Target Sample Size   Total Sample Size="44"
Sample Size from India="44" 
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)   09/04/2022 
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="6"
Days="0" 
Recruitment Status of Trial (Global)   Not Yet Recruiting 
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  

Diagnosed cases of Melasma fulfilling the inclusion criteria will be enrolled into clinical trial after obtaining written informed consent, then they will be randomly allocated into two groups each 23; viz Group A will receive local application of Tila of Tukhme Turb and Tukhme Jarjir and Group B Tila of Aad Baqla and Tukhme kharpazah, both groups will be given Joshanda Haleela Siyah orally along with hot water vapors fomentation. Assessment of outcome will be carried out with m-MASI Score and pGA Scale , photography of the lesions and Dermoscopy on 0 (baseline) 7th , 14th and on 21th day of the trial followed by Post trial follow u will made on 28th day to find out any residual effect of the therapy. Drug safety will be ensured by monitoring the haematological and serological indicators. Efficacy analysis will be performed on Intention-to-treat (ITT) basis using the last observation carry forward method (LOCF) on participants those received all the doses of both test and comparator drugs and underwent at least two assessment post baseline. The study data will be analyze statistically with appropriate test. P values of last than 0.05 will be considered statistically significant .


 
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