| CTRI Number |
CTRI/2019/02/017434 [Registered on: 05/02/2019] Trial Registered Prospectively |
| Last Modified On: |
28/01/2019 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group, Active Controlled Trial |
|
Public Title of Study
|
Tinea Corporis (Quba) and Unani Medicine |
|
Scientific Title of Study
|
Efficacy of Majoon Ushba and topical application of Marham Raal in Quba (Tinea Corporis) – A Randomized Standard Controlled Study |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Musab Ahmad |
| Designation |
PG Scholar |
| Affiliation |
National institute of unani medicine (NIUM) |
| Address |
Unit 1 Hostel National Institute Of Unani Medicine, Kottigepalya Magadi Main Road bangalore
D/O Moalajat, NIUM Kottigepalya Magadi Main Road Bangalore pin- 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
9997498033 |
| Fax |
|
| Email |
musabahmad@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Abdul Mobeen |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore
NIUM Kottigepalya Magadi Main Road Bangalore pin- 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8123143721 |
| Fax |
|
| Email |
dr.mobeen@rediffmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Abdul Mobeen |
| Designation |
Lecturer |
| Affiliation |
National Institute Of Unani Medicine |
| Address |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road Bangalore
NIUM Kottigepalya Magadi Main Road Bangalore pin- 560091
Bangalore
KARNATAKA
560091
India |
| Phone |
8123143721 |
| Fax |
|
| Email |
dr.mobeen@rediffmail.com |
|
|
Source of Monetary or Material Support
|
| National Institute Of Unani Medicine |
|
|
Primary Sponsor
|
| Name |
National Institute Of Unani MedicineNIUM |
| Address |
NIUM Kottigepalya Magadi Main Road Bangalore pin-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 |
| Musab Ahmad |
OPD/IPD Of National Institute Of Unani Medicine |
National Institute Of Unani Medicine Kottigepalya Magadi Main Road 560091
Bangalore
KARNATAKA |
9997498033
musabahmad@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethics Committee |
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 Ushba |
6 gm BD orally Before meal for 40 days |
| Intervention |
Marham Raal |
Local application TDS for 40 days |
| Comparator Agent |
Terbinafine 1 % Cream |
Local application BD for 40 days |
|
|
Inclusion Criteria
|
| Age From |
10.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
1.Clinically diagnosed patients of Quba (confirmed on Direct Microscopy).
2.Patients who have agreed to sign the informed consent form and follow the protocol.
|
|
| ExclusionCriteria |
| Details |
1.Patients below and above the age of 10 and 60 years respectively.
2.Patient suffering from concomitant diseases like psoriasis & Eczema.
3.Patient suffering from severe systemic and metabolic diseases.
4.Diabetic and HIV patient.
5.Pregnant & Lactating Women.
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
1. In the present study, the efficacy of the treatment will be determined by decrease in grades from higher to lower i.e. from grade 3 to grade 2, grade 2 to grade 1, grade 1 to grade 0 with each parameter. Grade 0 is the highest level of cure that can be attained by the patient.
2. The total score includes the scores of colour of the lesion, scaling of the lesion, itching, and margins of the lesion, size of the lesion and KOH mount.
|
Baseline or 0 day 10th day, 20th day, 30th day and 40th day of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. Negative KOH Microscopy
2. Dermatology Life Quality Index (DLQI)
|
Pre and post study |
|
|
Target Sample Size
|
Total Sample Size="42"
Sample Size from India="42"
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)
|
11/02/2019 |
| 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
|
nil |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
Superficial
dermatophytosis of the skin in the form of Tinea corporis (Quba) is a very common infection seen in clinical practice. According to a
World Health Organization survey on the prevalence of dermatophyte infection it
was found that 20% of people presenting for clinical advice are suffering from
cutaneous fungal infections worldwide.Despite the increasing prevalence of cutaneous dermatophytosis
across the world, and especially in tropics, research in this area has often
been neglected.
Unani
Medicine lacks evidence based anti fungal therapy for dermatophytosis. Although
there are formulations which are indicated and tested by for centuries. On the
basis of these incidence, treatment failure (especially in chronic infection)
and decreased quality of life due to infection, it is need of hours to conduct
a trial based on Unani Medicine. Hence, in order to validate and provide effective
management of Quba (Tinea Corporis), the present study entitled “Efficacy of Majoon
Ushba and topical application of Marham
Raal in Quba (Tinea Corporis) – A Randomized Standard Controlled Study†has been designed |