| CTRI Number |
CTRI/2020/04/024609 [Registered on: 14/04/2020] Trial Registered Prospectively |
| Last Modified On: |
31/03/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Unani |
| Study Design |
Randomized, Parallel Group Trial |
|
Public Title of Study
|
Trial of Unani medicine in the patients of Fungal infection of skin |
|
Scientific Title of Study
|
A prospective Randomized standard control clinical trial of Unani formulation in the management of Dermatomycoses |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Zamir Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Amraze Jild wa zohrawiya, Ajmal Khan Tibbiya College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
|
| Email |
drzamiramrohi@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Zamir Ahmad |
| Designation |
Associate Professor |
| Affiliation |
Aligarh Muslim University |
| Address |
Department of Amraze Jild wa zohrawiya, Ajmal Khan Tibbiya College and Hospital, Aligarh Muslim University, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
|
| Email |
drzamiramrohi@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Zamir Ahmad |
| Designation |
Scholar |
| Affiliation |
|
| Address |
Deptt. of Amraze jild, AK Tibbiya College Hospital, AMU, Aligarh
Aligarh
UTTAR PRADESH
202002
India |
| Phone |
8475007594 |
| Fax |
|
| Email |
drzamiramrohi@gmail.com |
|
|
Source of Monetary or Material Support
|
| Department of Amraze jild wa Zohrawiya, Faculty of Unani Medicine, Aligarh Muslim University, Aligarh |
|
|
Primary Sponsor
|
| Name |
Aligarh Muslim University |
| Address |
Department of Amraze jild wa zohrawiya, AKTC, 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 Zamir Ahmad |
Ajmal Khan Tibbiya College and Hospital |
Department of Amraze Jild skin
AKTC Aligarh Muslim University
Aligarh
UTTAR PRADESH |
08475007594
drzamiramrohi@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 |
| Comparator Agent |
Terbinafine cream |
for local application daily twice a day for 6 weeks |
| Intervention |
Unani pharmacopeal formulation |
as local application daily twice a day for 06 weeks |
|
|
Inclusion Criteria
|
| Age From |
13.00 Year(s) |
| Age To |
70.00 Year(s) |
| Gender |
Both |
| Details |
Patients with sign and symptoms of Dermatomycoses |
|
| ExclusionCriteria |
| Details |
Patient of Tinea capitis, Tinea ungium,impaired liver function, impaired renal function,Hypersensitivity of drugs, Malignancy, Epilepsy. Patients on prolong medication for any systemic disorder,on systemic corticoseteroid, disease modyfiny agents. Patients with secondary infection or any other infective disorder requiring long term treatment.Alcohalics, Drug Addicts,Pregnant or Lactating mother. |
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
An Open list of random numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Unani formulation will be effective in treating Dermatomycoses |
08 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Unani formulation will relieve of the symptomps of Dermacomycoses |
08 weeks |
|
|
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)
|
27/04/2020 |
| 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="2"
Months="0"
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
|
The purpose of this study is to determine and validate the safety and efficacy of Unani pharmacopeal formulation on the patients of fungal infection of the skin. The Results of this study will be published in the Journals. |