| 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
|
|
|
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
|
|
|
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 ḌimÄd e jarab and Gandhak possessing Muḥallil (resolvent), JÄlÄ« (detergent), Daf‘-i-Ta‘affun (disinfectant), and MudÄmmil -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. |