| CTRI Number |
CTRI/2020/03/023861 [Registered on: 09/03/2020] Trial Registered Prospectively |
| Last Modified On: |
08/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
treatment of qooba (tinea cruris) with unani formulations |
|
Scientific Title of Study
|
Efficacy of Majoon-e-Shahtara and Zimad in Tinea cruris – An Open Labelled Single Arm Interventional Clinical Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MOHAMMAD DANISH |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of Amraze Jild Wa Tazeeniyat, National Institute of Unani Medicine National Institute Of Unani Medicine
Kottigepallya Magadi Main Road
Bangalore Rural
KARNATAKA
560091
India |
| Phone |
6307660289 |
| Fax |
|
| Email |
mohddanish3189@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR MOHAMMAD RUMAN KHAN |
| Designation |
Lecturer, Department of Amraze Jild Wa Tazeeniyat, National Institute of Unani Medicine |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine, Kottigepallya Magadi Main Road, Bangalore Karnatka-560091
Bangalore Rural
KARNATAKA
560091
India |
| Phone |
9450090387 |
| Fax |
|
| Email |
dr.rumman190@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
MOHAMMAD DANISH |
| Designation |
P.G. Scholar |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
Department of Amraze Jild Wa Tazeeniyat, National Institute of Unani Medicine
Kottigepadllya Magadi Main Road
Bangalore Rural
KARNATAKA
560091
India |
| Phone |
06307660289 |
| Fax |
|
| Email |
mohddanish3189@gmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute of Unani Medicine, Bangalore |
|
|
Primary Sponsor
|
| Name |
National Institute of Unani Medicine |
| Address |
National Institute of Unani Medicine, Kottigepallya, Magadi Main Road, Bangalore, Karnatka |
| 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 |
| Mohammad Danish |
National Institute of Unani Medicine |
Department of Amraze Jild Wa Tazeeniyat
Bangalore
KARNATAKA |
06307660289
mohddanish3189@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee (IEC) for Biomedical Research |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Majoon-e-Shahtara and Zimad |
Majoon-e-Shahtara 7 g twice daily will be administered orally with water (after meal) and Zimad will be applied locally twice a day for 4 weeks. |
| Comparator Agent |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
20.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
Clinically and microscopically diagnosed patient of Tinea cruris
Patient of either gender
Age group 20-50 years
Patient who have agreed to sign the informed consent form
|
|
| ExclusionCriteria |
| Details |
Patient below 20 years and above 50 years of age
Pregnant and lactating women
Patient with severe systemic and metabolic disorders
Diabetic, HIV/AIDS or other immunocompromised patients
Patient with concomitant skin disease like eczema and psoriasis
Patient who are taking conventional medicine for Tinea cruris will be enrolled for the trial after a washed out period of 15 days
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Improvement in subjective parameters |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Improvement in objective parameters |
28 days |
|
|
Target Sample Size
|
Total Sample Size="30"
Sample Size from India="30"
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)
|
10/03/2020 |
| 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) |
Not Yet Recruiting |
|
Publication Details
|
After completion of the trial, the paper will be published in peer reviewed national & international journal |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
| Diagnosed cases of Tinea cruris fulfilling the inclusion criteria will be enrolled into clinical trial after obtaining written informed consent. All subjects will be given test drugs Majoon-e-Shahtara 7g orally twice daily with water (after meal) and Zimad for local application twice daily for 4 weeks, followed by two weeks (35th and 42nd day) of post-trial follow ups for assessment of any relapse. Assessment of study outcome will be made on the basis of observation of baseline and each follow up in the form subjective and objective parameters. The subjective parameters will be assessed with an arbitrary grading 4 – point Likert scale (where 0 = nil, 1 = mild, 2 = moderate and 3 = severe) accordingly objective parameters like photography of the lesions and KOH microscopy will be assessed on 0th (baseline) and on 4th week. Following two more follow ups will be made to assess any relapse of the trial effect. |
|