| CTRI Number |
CTRI/2024/05/066758 [Registered on: 03/05/2024] Trial Registered Prospectively |
| Last Modified On: |
27/04/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani |
| Study Design |
Other |
|
Public Title of Study
|
Clinal Trial With Oral and Local drugs in management of Tinea Corporis |
|
Scientific Title of Study
|
Efficacy and safety of Itrifal Shahtara and Marham Daad with Comparison of Majoon Ushba and Marham Raal in the management of Quba (Tinea Corporis) An Open-Labeled Randomized Comparative Clinical Study. |
| Trial Acronym |
Nil |
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Md Shamim Akram |
| Designation |
PG Scholar |
| Affiliation |
Government Tibbi College and Hospital |
| Address |
Department of Moalajat (Medicine) Govt. Tibbi College and Hospital
Patna
BIHAR
800003
India |
| Phone |
8791256169 |
| Fax |
|
| Email |
mdshamimakram56@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Md Razi Ahmad |
| Designation |
Assistant professor |
| Affiliation |
Government Tibbi College and Hospital |
| Address |
Department of Moalajat (Medicine) Govt. Tibbi College and Hospital
Kadamkuan
Patna
BIHAR
800003
India |
| Phone |
7909035622 |
| Fax |
|
| Email |
dr.razi.ahmed91@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Md Tanwir alam |
| Designation |
Assistant Professor |
| Affiliation |
Government Tibbi College and Hospital |
| Address |
Department of Tahaffuzi wa samaji tib (preventive and social
Medicine) Govt. Tibbi College and Hospital
Patna
BIHAR
800003
India |
| Phone |
800003 |
| Fax |
|
| Email |
tanveernium3133@gmail.com |
|
|
Source of Monetary or Material Support
|
| Govt tibbi college and hospital, patna |
|
|
Primary Sponsor
|
| Name |
Government Tibbi College and Hospital |
| Address |
Government Tibbi College and Hospital Kadamkuan Patna 800003 |
| 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 Md Shamim Akram |
Govt Tibbi College and Hospital |
Room No- 30, Department of Skin, Govt tibbi College and hospital, Arya Road, kadamkuan
Patna
BIHAR |
8791256169
mdshamimakram56@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee, Govt. Tibbi College and Hospital,Patna |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: B354||Tinea corporis, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Comparator Agent |
Majoon Ushba - Orally
Marham Raal- Locally |
1. Majoon Ushba
Dose-5-7 gm
Frequency- once a day
Route of administraion -Orally
Duration- 6 weeks
2. Marham Raal
Dose- 5-10 gm
Frequency- once a day
Route of Administration -Locally |
| Intervention |
Oral- Itrifal Shahtara
Local- Marham daad |
1.Itrifal Shahtara- 5-7gm
Frequency-Once day.
Route of administration- Orally
Duration- 6 weeks
2.Marham Daad
frequency- Twice a day
Route of Administration- Lacally
Duration-6 weeks |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
50.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients those who have subjective and objective signs and symptoms or diagnosed case of Tinea corporis.
2.Patients with positive mycology test(KOH positive).
3.Patients of either gender.
4.Patients in the age group of 18-50 years.
5.Patients who have agreed to participate and sign the informed consent form and follow the protocol. |
|
| ExclusionCriteria |
| Details |
1.Co-morbid conditions of the participant like DM, HTN, CAD, CKD and other autoimmune diseases.
2.Participants suffering from concomitant diseases like Psoriasis and eczema.
3.Pregnant or lactating women.
4.Known cases of immuno-compromised states like AIDS, Malignancies and on immuno-suppressive drugs
5.Participants fail to attend treatment schedule regularly. |
|
|
Method of Generating Random Sequence
|
Coin toss, Lottery, toss of dice, shuffling cards etc |
|
Method of Concealment
|
Alternation |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| Total Sign and symptom score(TSSS) |
1st week to 6 weeks |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Conversion to Negative mycology test |
At 6 Week |
|
|
Target Sample Size
|
Total Sample Size="60"
Sample Size from India="60"
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)
|
20/05/2024 |
| 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="0"
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
|
Patient of tinea corporis is included in the study on the basis of inclusion and exclusion criteria and the effect of unani formulation compared with standard drug |