FULL DETAILS (Read-only)  -> Click Here to Create PDF for Current Dataset of Trial
CTRI Number  CTRI/2017/07/009004 [Registered on: 10/07/2017] Trial Registered Prospectively
Last Modified On: 10/03/2023
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   Evaluation of efficacy and safety of Unani formulation in Acne 
Scientific Title of Study   Clinical evaluation of Unani formulations in the management of Busoor Labaniyah (Acne vulgaris). 
Trial Acronym  CEUFMAV 
Secondary IDs if Any  
Secondary ID  Identifier 
NIL  NIL 
 
Details of Principal Investigator or overall Trial Coordinator (multi-center study)  
Name  Dr Samreen Khan 
Designation  M.D. Scholar  
Affiliation  Jamia Hamdard 
Address  Dept. of Moalajat, Faculty of Medicine(Unani), Jamia Hamdard

South
DELHI
110062
India 
Phone  8510023869  
Fax    
Email  dr.samreenkhan24@gmail.com  
 
Details of Contact Person
Scientific Query  
Name  Dr Yasmeen Shamsi 
Designation  Professor and Head of department 
Affiliation  Jamia Hamdard 
Address  Dept. of Moalajat, Faculty of Medicine(Unani), Jamia Hamdard

South
DELHI
110062
India 
Phone  8750040776  
Fax  26059692  
Email  yshamsi@jamiahamdard.ac.in  
 
Details of Contact Person
Public Query  
Name  Dr Umar Jahangir 
Designation  Assistant Professor 
Affiliation  Jamia Hamdard 
Address  Dept. of Moalajat, Faculty of Medicine(Unani), Jamia Hamdard

South
DELHI
110062
India 
Phone  8285684500  
Fax    
Email  umar_jehangir@doctor.com  
 
Source of Monetary or Material Support  
Jamia Hamdard (University) Hamdard Nagar New Delhi-110062 
 
Primary Sponsor  
Name  Dept of Moalajat Jamia Hamdard 
Address  Faculty of Medicine (Unani) Jamia Hamdard New Delhi- 62 
Type of Sponsor  Private 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 
Dr Samreen khan  Clinical research OPD   Room no. 11, Department of Moalajat, Majeedia Unani Hospital, Jamia Hamdard
South
DELHI 		 8510023869

dr.samreenkhan24@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC), Jamia Hamdard   Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  Acne Vulgaris,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Standard control- Benzoyl peroxide and Tab. Azithromycin  Topical:- Benzoyl peroxide 5% gel once daily Oral:- Tab. Azithromycin 500 mg thrice weekly(i.e, on Mon, Wed, Fri). for a period of 8 weeks  
Intervention  Unani formulation- Zimad-e-Muhasa & Cap. Shahatra  Topical:- Zimad-e-Muhasa to be applied as paste once daily. Oral:- Cap. Shahtra 2 BD (Dried aqueous extract of 5g of Barg-e-Shahtra (leaves of (Fumaria parviflora Lam.)) for a period of 8 weeks  
 
Inclusion Criteria  
Age From  13.00 Year(s)
Age To  35.00 Year(s)
Gender  Both 
Details  Patients with moderate to severe acne (score of acne 19-38), as per the Global Acne Grading System (GAGS). 
 
ExclusionCriteria 
Details  Pregnant and lactating women.
Patients using hormonal contraceptives.
Patients suffering from PCOD.
Patients suffering from other concomitant skin diseases.
Patients having liver & renal diseases.
Patients using drugs known to be photo sensitizers and anti-androgenic drugs.
Patients who have used topical anti-acne medications within the past two weeks.
Patients who have used systemic antibiotic within past one month.
Patients who have used isotretinoin in the last six months.
Patients using medications that are reported to exacerbate acne.
Patients have had chemical or laser peel & artificial UV therapy.
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   On-site computer system 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
GAGS Scale (Global Acne Grading System).  0 Day, 14th Day, 28th Day, 42nd Day, 56th Day 
 
Secondary Outcome  
Outcome  TimePoints 
Coloured photographs of the lesion with the same magnification.

 		 0 Day & 56th Day 
The Cardiff Acne Disability Index - to assess quality of life  0 Day, 28th Day, 56th Day 
Likert scale: Itching, erythema & scaring will be assessed on likert scale (0-3)  0 Day, 14th Day, 28th Day, 42nd Day, 56th Day 
safety parameters include (CBC with ESR, LFT, KFT, U-R/M  0 Day & 56th Day
 
 
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 
Date of First Enrollment (India)   15/07/2017 
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)
Modification(s)  		 Not Applicable 
Recruitment Status of Trial (India)  Closed to Recruitment of Participants 
Publication Details   The researcher will publish the results of the study as per the policy laid down by Jamia Hamdard. 
Individual Participant Data (IPD) Sharing Statement

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

Brief Summary  
This study is a randomized, open label, standard controlled trial, comparing the safety and efficacy of test and control drugs. The test drugs comprises of  topical drug: Zimad-e-Muhasa  which is composed of Irsa (Iris ensata Thunb), Barg-e-Neem (Azadirachta indica A. Juss.), Post-e-Siris (Albizia lebbeck (L.) Benth.) , Ghungchi safaid (Abrus precatorius Linn.) and Namak-e-sambhar (Lake salt) in equal proportion to be applied as paste once daily and the oral drug is Cap. Shahtra 2 capsules twice daily equivalent to 5 g of dried aqueous extract of Barg-e-Shahtra (leaves of Fumaria parviflora Lam.)) and the control drugs includes topical drug: benzoyl peroxide 5% gel once daily and Tab. Azithromycin 500mg thrice weekly i.e.,on Mon,Wed, Fri ) for a period of 8 weeks in 60 patients randomly allocated into test and control groups i.e., 30 patients in each group with Acne vulgaris in moderate to severe category that will be conducted in Majeedia Unani Hospital, New Delhi India and HAHC Hospital Jamia Hamdard, New Delhi, India. The primary outcome measures will be GAGS (Global Acne Grading System) scale to assess improvement in lesions  at baseline, 2nd week 4th week 6th week and 8 week The secondary outcomes will be photographs of lesions at baseline and 8 week, likert scale to assess itching, erythema and scaring  at baseline, 2nd week 4th week 6th week and 8 week and Cardiff Acne Disability Index to assess quality of life at baseline 4th week and 8 week. The safety and tolerability of test and control will be assessed on clinical sign and symptoms and laboratory parameters including CBC with ESR, LFT, KFT Urine-R/M before and after treatment. USG-lower abdomen will be done to exclude women with PCOD. The study is approved by Board of studies (BOS) of the institution on 10th February 2017 and approved by Institutional ethics committee (IEC) of Jamia Hamdard on 24th may 2016. 
 
Close