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CTRI Number  CTRI/2024/09/073345 [Registered on: 04/09/2024] Trial Registered Prospectively
Last Modified On: 29/08/2024
Post Graduate Thesis  Yes 
Type of Trial  Interventional 
Type of Study   Drug
Unani
Diagnostic 
Study Design  Randomized, Parallel Group, Active Controlled Trial 
Public Title of Study   Efficacy of Tila Qatran Madani with Shibb Yamani versus Permethrin in Jarab  
Scientific Title of Study   Efficacy of Tila Qatran Madani with Shibb Yamani versus Permethrin in Jarab (Scabies) - A Randomized Control Clinical Trial 
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 Zainab Aman 
Designation  PG Scholar 
Affiliation  National Institute of Unani Medicine 
Address  Amraze Jild wa Tazeeniyat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  7983329734  
Fax    
Email  zainabamangf1918@gmail.com  
 
Details of Contact Person
Scientific Query
 
Name  Prof Mohd Aleemuddin Quamri  
Designation  HOD Amraze Jild Wa Tazeeniyat and Moalajat (i/c) 
Affiliation  National Institute of Unani Medicine 
Address  Amraz e Jild wa Tazeeniyat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Details of Contact Person
Public Query
 
Name  Prof Mohd Aleemuddin Quamri  
Designation  HOD Amraze Jild Wa Tazeeniyat and Moalajat (i/c) 
Affiliation  National Institute of Unani Medicine 
Address  Amraz e Jild wa Tazeeniyat, National Institute of Unani Medicine, Kottigepalya, Magadi Main Road, Bangalore

Bangalore
KARNATAKA
560091
India 
Phone  9341072974  
Fax    
Email  drmaquamri@gmail.com  
 
Source of Monetary or Material Support  
National Institute of Unani Medicine,Kottigepalya,Magadi Main road, Bangalore,Karnataka,India, 560091 
 
Primary Sponsor  
Name  National Institute of Unani Medicine 
Address  Amraz e jild wa tazeeniyat National Institute of Unani Medicine,Kottigepalya,Magadi main road,Bangalore,Karnataka,India,560091 
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 
DrZainab Aman  National Institute of Unani Medicine  OPD-4,National Institute of Unani Medicine,Kottigepalya, Magadi main road, Bangalore
Bangalore
KARNATAKA 
7983329734

zainabamangf1918@gmail.com 
 
Details of Ethics Committee  
No of Ethics Committees= 1  
Name of Committee  Approval Status 
Institutional Ethics Committee (IEC) for Biomedical Research  Approved 
 
Regulatory Clearance Status from DCGI  
Status 
Not Applicable 
 
Health Condition / Problems Studied  
Health Type  Condition 
Patients  (1) ICD-10 Condition: B86||Scabies,  
 
Intervention / Comparator Agent  
Type  Name  Details 
Comparator Agent  Permethrin lotion  Group B subject will be given 50ml Permethrin 5% lotion for local application once a week for 2weeks. Assessment will be done on 0,7 and 14 day 
Intervention  Tila Qatran Madani with Shibb Yamani  Group A will receive 50ml Qatran e madani and Shibb e yamani solution for local application once a week for 2 weeks. Assessment will be done on 0,7 and 14 day.  
 
Inclusion Criteria  
Age From  8.00 Year(s)
Age To  39.00 Year(s)
Gender  Both 
Details  Patients of either sex
Diagnosed case by IACS criteria
Age more than 8 years to 39 years
Pruritus without excoriation since 6 months 
 
ExclusionCriteria 
Details  Pregnant and lactating women
Use of topical and systemic acaricide drugs from past 1 month
 
 
Method of Generating Random Sequence   Computer generated randomization 
Method of Concealment   Not Applicable 
Blinding/Masking   Open Label 
Primary Outcome  
Outcome  TimePoints 
Negative Dermoscopy
Decrease in Pruritus
Negative KOH scraping
 
0,7,14 day 
 
Secondary Outcome  
Outcome  TimePoints 
Decrease in no of lesions
Burrow Ink Test 
0,7,14 day 
 
Target Sample Size   Total Sample Size="38"
Sample Size from India="38" 
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)   09/09/2024 
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 Applicable 
Recruitment Status of Trial (India)  Open to Recruitment 
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  

Scabies is an intensely itchy parasitic disease of the skin caused by microscopic scabies mites that are transmitted from person to person via close contact.Human scabies is caused by the mite Sarcoptes scabei var. hominis, which is an obligate ectoparasite that lives in the human epidermis.The WHO estimates that there are more than 200 million scabies cases worldwide, however this number certainly drastically underestimates the true scope of the condition. Scabies is more prevalent in vulnerable groups such as young children and the elderly.The Global Burden of Diseases study estimates that scabies affects 455 million persons leading to approximately 3.8 million disability-adjusted life-years (DALYs); making scabies one of the most common neglected tropical diseases. Scabies has serious physical repercussions, but it also has severe psychosocial implications, including itchiness, insomnia, decreased productivity, low quality of life, and in one research, a sense of shame in 77% of those who had it.The first-line treatments of scabies include oral ivermectin and topical permethrin. Malathion,Topical sulfur, Benzyl benzoate, crotamiton, topical ivermectin and lindane are examples of other treatment agents.Adverse effects of antiscabetics occur infrequently and are limited to local cutaneous reactions including erythema, burning, pruritus and post scabies eczema.The use of antiscabetics cause irritant dermatitis on the face and scrotum, repeated usage may lead to allergic dermatitis. neurotoxicity, cramps, CNS toxicity, dizziness and convulsions.  It is forbidden in pregnant and lactating women, infants, and young children less than 2 years of age.Even though there has been a lot of exploration and extensive research on scabies treatment around the world to date, but still the excellent treatment is obscure.In Unani system of medicine various single drugs and compound formulatios such as Ḍimād e jarab and Gandhak possessing Muḥallil (resolvent), JālÄ«  (detergent), Daf‘-i-Ta‘affun (disinfectant), and Mudāmmil -e- QurÅ«hÌ£ (cicatrizant) properties have been scientifically proven to be effective in treatment of scabies. Qatran e ma’dani and Shibb e yamani, ancient, effective and affordable drugs possessing above mentioned properties yet not been scientifically proven are selected for clinical trial.

 
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