| CTRI Number |
CTRI/2024/04/065285 [Registered on: 05/04/2024] Trial Registered Prospectively |
| Last Modified On: |
29/03/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Other (Specify) [Dermatophytosis] |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Effect of Unani Formualtions in Qooba |
|
Scientific Title of Study
|
Comparative Clinical Evaluation of Unani Formulations With Special Reference to Mizaj in the Treatment of Qooba [Dermatophytosis] |
| Trial Acronym |
NIL |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Mubashira Karimi |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraze jild wa Zohrawiya Near BSNL Office Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7037781149 |
| Fax |
|
| Email |
mubashirakarimi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Prof Shagufta Aleem |
| Designation |
Professor |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraze jild wa Zohrawiya Near BSNL Office Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
9897249995 |
| Fax |
|
| Email |
s.aleem786@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Mubashira Karimi |
| Designation |
PG Scholar |
| Affiliation |
Ajmal Khan Tibbiya College |
| Address |
Department of Amraze jild wa Zohrawiya Near BSNL Office Aligarh Muslim University Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
7037781149 |
| Fax |
|
| Email |
mubashirakarimi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department Amraze jild wa zohrawiya Ajaml khan tibbiya college Aligarh Muslim University ALIGARH |
|
|
Primary Sponsor
|
| Name |
Department Amraze jild wa zohrawiya Ajaml khan tibbiya college Aligarh Muslim University ALIGARH |
| Address |
Department Amraze jild wa zohrawiya Ajaml khan tibbiya college Aligarh Muslim University ALIGARH |
| Type of Sponsor |
Government medical college |
|
|
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 |
| DR MUBASHIRA KARIMI |
Amraze Jild Wa Zohrawiya Ajmal Khan Tibbiya College AMU |
Amraze Jild Wa Zohrawiya Ajmal Khan Tibbiya College AMU
Aligarh
UTTAR PRADESH |
7037781149
mubashirakarimi@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| INSTITUTIONAL ETHICS COMMITTEE FACULTY OF UNANI MEDICINE AMU ALIGARH |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B35||Dermatophytosis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
Joshanda Chiraita and
Absinthium oil based cream |
Joshanda Chiraita given orally 5-7 gm twice a day for 28 days
Absinthium oil based cream apply locally twice a day for 28 days |
| Comparator Agent |
Joshanda Chiraita and
Marham e hina |
Joshanda Chiraita 5-7 gm given orally twice a day for 28 days.
Marham e hina applied locally twice a day for 28 day. |
|
|
Inclusion Criteria
|
| Age From |
15.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients of Tinea [Quba] attending OPD of AKTC hospital confirmed by Direct microscopy .
Patients of either gender .
Age group 15-60 years .
Patients who have agreed to sign the informed consent form , comply with the study procedure, and availability for regular follow up during the protocol .
|
|
| ExclusionCriteria |
| Details |
Patients of Tinea [Quba] attending OPD of AKTC hospital confirmed by Direct microscopy .
Patients of either gender .
Age group 15-60 years .
Patients who have agreed to sign the informed consent form , comply with the study procedure, and availability for regular follow up during the protocol .
|
|
|
Method of Generating Random Sequence
|
Random Number Table |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Participant Blinded |
|
Primary Outcome
|
| Outcome |
TimePoints |
Outcomes of the treatment will be assessed by three parameters.
Clinical Cure.
Mycological Cure[ negative KOH Preparation] .
Photography of the lesions .
|
Assesment of all parameters at initiation of the study 0 day, 7 day, 14, 21 and 28 day of the study |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
Itching
Erythematous areas with elevated margins.
Erythematous papules.
Vesicles around a variable pigmented patch.
Scaling
|
Assessment of all parameters at initiation of the study 0 day 7 day, 14 ,21 ,28 day of the study |
|
|
Target Sample Size
|
Total Sample Size="104"
Sample Size from India="104"
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)
|
22/04/2024 |
| 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) |
Not Yet Recruiting |
|
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
|
Dermatophytosis is a fungal infection in the skin’s stratum
corneum layer caused by species of genera: Trichophyton, Microsporum, and Epidermophyton, and
affecting 20–25% of the world population with varying geographic distribution. The
most common agents of superficial fungal infections worldwide are
dermatophytes. The infection is widespread in developing countries, especially
in tropical and subtropical countries like India resulting in significant
distress to the patients socially, emotionally, and
financially. Tinea is the most
common infection in which the skin is
infected by dermatophytes, and its clinically characterized by annular or
arcuate lesions with relative clearing in the center and an active periphery. Unani medicine is one of the most ancient traditional
systems of medicine and has its own conceptual framework for studying health
and disease in human beings.
|