| CTRI Number |
CTRI/2022/08/044906 [Registered on: 25/08/2022] Trial Registered Prospectively |
| Last Modified On: |
24/08/2022 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Interventional |
|
Type of Study
|
Drug
Unani
Screening |
| Study Design |
Single Arm Study |
|
Public Title of Study
|
Effect of Unani formulation in Tinea Corporis |
|
Scientific Title of Study
|
Efficacy of Nuqoo e Mundi(Sphaeranthus indicus) and Roghan e Neem(Azadirachta indica) in Quba [Tinea corporis] |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Dr Sayema Khan |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Siddaiah puranik road Basaveshwar nagar bangalore
Siddaiah puranik road Basaveshwar nagar bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
7289805073 |
| Fax |
|
| Email |
sayemakhan91@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr mohammed Asif siddiqi |
| Designation |
Associate Professor |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Siddaiah puranik road Basaveshwar nagar bangalore
Siddaiah puranik road Basaveshwar nagar bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
9986812499 |
| Fax |
|
| Email |
drasif.i.siddiqui@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Sayema Khan |
| Designation |
PG Scholar |
| Affiliation |
Government Unani Medical College and Hospital |
| Address |
Siddaiah puranik road Basaveshwar nagar bangalore
Siddaiah puranik road Basaveshwar nagar bangalore
Bangalore
KARNATAKA
560079
India |
| Phone |
9986812499 |
| Fax |
|
| Email |
sayemakhan91@gmail.com |
|
|
Source of Monetary or Material Support
|
| Room no 8 Government Unani Medical College and Hospital karnataka Bengaluru |
|
|
Primary Sponsor
|
| Name |
Government unani medical college and hospital Bengaluru Karnataka |
| Address |
Dr siddaiah puranik road basaveshwar nagar bengaluru karnataka 560079 |
| 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 |
| Dr Sayema khan |
Government Unani Medical College and Hospital |
Department of Amraz e Jild Wa Tazeeniyat 80 feet ring road stage 1 KHB colony basaveshwar nagar bangalore
Bangalore
KARNATAKA |
7289805073
sayemakhan91@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| Institutional Ethical Committee 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 |
Mundi and Neem |
Nuqoo e Mundi 7gm in 30 ml of water in the morning empty stomach orally for 28 days
Roghan-e-Neem For local application over the lesion twice a day for 28 days
|
| Comparator Agent |
Not applicable |
not applicable |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
60.00 Year(s) |
| Gender |
Both |
| Details |
Patients age between 18-60 years of all gender
Mycological(KOH) confirmed cases of tinea corporis (KOH +ve cases)
Patients with 2 years of chronicity of tinea corporis
Patients who are willing to sign the consent form for the trial
|
|
| ExclusionCriteria |
| Details |
Age group less than 18 years or more than 60 years
Patients with DM HTN renal and hepatic impairement hypersensitivity to drug
Patients with severe skin infections
Pregnant and lactating mothers
Cases other than tinea corporis
Patient on corticosteroid treatment
|
|
|
Method of Generating Random Sequence
|
Computer generated randomization |
|
Method of Concealment
|
Case Record Numbers |
|
Blinding/Masking
|
Open Label |
|
Primary Outcome
|
| Outcome |
TimePoints |
| KOH examination of skin scrap should be negative |
28 days |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| Reduction in subjective parameters will be according to arbitrary grading scale or physicians global assesment score |
0th 7th 14th 21st 28th 35th day |
|
|
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)
|
01/09/2022 |
| 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
|
Not yet published |
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
Response - NO
|
|
Brief Summary
|
Clinically diagnosed cases
of tinea corporis fulfilling the inclusion criteria after obtaining written
consent will be enrolled in the intervention of Nuqoo-e-Mundi(orally) 7 gms
with 30 ml of water and local application of Roghan-e- Neem (twice a day) for a
duration of 28 days with follow up assessment on every 7th day (7th 14th 21st 28th 35th day). The pre
and post treatment objective findings(effects) will be assessed. |