| CTRI Number |
CTRI/2024/06/068849 [Registered on: 13/06/2024] Trial Registered Prospectively |
| Last Modified On: |
11/06/2024 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cross Sectional Study |
| Study Design |
Other |
|
Public Title of Study
|
Studying drug reaction on skin and mucous membrane and performing dermoscopy in patients coming to sir t hospital bhavnagar |
|
Scientific Title of Study
|
A study of clinical and dermoscopic findings in patients of mucocutaneous adverse drug reactions attending tertiary care center Bhavnagar - Cross sectional observational 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 |
Dr Ram jignashaben meramanbhai |
| Designation |
First year resident doctor |
| Affiliation |
Government medical college Bhavnagar |
| Address |
Room No. 115,Skin OPD,Sir T Hospital jail road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8141181007 |
| Fax |
|
| Email |
jignasharam007@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
Dr Hita mehta |
| Designation |
Professor and head of department of DVL |
| Affiliation |
Government medical college Bhavnagar |
| Address |
Room no.115,skin opd,sir T hospital jail road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
9429503188 |
| Fax |
|
| Email |
hitamehta88@gmail.com |
|
Details of Contact Person
Public Query
|
| Name |
Dr Ram jignashaben meramanbhai |
| Designation |
First year resident doctor |
| Affiliation |
Government medical college Bhavnagar |
| Address |
Room no.115,skin opd ,sir T hospital jail road, Bhavnagar
Bhavnagar
GUJARAT
364001
India |
| Phone |
8141181007 |
| Fax |
|
| Email |
jignasharam007@gmail.com |
|
|
Source of Monetary or Material Support
|
| Sir T hospital,government medical college Bhavnagar |
|
|
Primary Sponsor
|
| Name |
Dr Ram jignashaben meramanbhai |
| Address |
Room no.115,skin opd,Sir T hospital,jail road,Bhavnagar |
| Type of Sponsor |
Other [Self] |
|
|
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 Ram jignashaben meramanbhai |
Sir T hospital,Bhavnagar |
Room no.115,skin opd,Sir T hospital,jail road, Bhavnagar
Bhavnagar
GUJARAT |
8141181007
jignasharam007@gmail.com |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| ETHICS COMMITTEE GOVERNMENT MEDICAL COLLEGE ,BHAVNAHAR |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
|
Health Condition / Problems Studied
|
| Health Type |
Condition |
| Patients |
(1) ICD-10 Condition: L99||Other disorders of skin and subcutaneous tissue in diseases classified elsewhere, |
|
|
Intervention / Comparator Agent
|
| Type |
Name |
Details |
| Intervention |
NIL |
NIL |
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
Patients of age 18-80 years presenting with mucocutaneous lesions following intake of any drugs those who fulfilled the category of probable or possible drug reaction as per Naranjo’s causality assessment scale .
|
|
| ExclusionCriteria |
| Details |
Patients who are unwilling to give consent will be excluded from the study.
Patients below 18 years of age
Patients with hair and nail changes of mucocutaneous adverse drug reactions |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
| To study clinical and dermoscopic findings in patients of mucocutaneous adverse drug reactions |
At the end of 12 months |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1)TO OBSERVE NEW DERMOSCOPIC FINDINGS IF ANY
2)To evaluate offending drug in particular drug reaction.
3)To assess severity in mucocutaneous adverse drug reactions by Hartwig and siegel severity assessment scale among these patients.
4)To assess preventability in mucocutaneous adverse drug reactions by modified schumock and thornton preventability scale among these patients. |
AT THE END OF 12 MONTHS |
|
|
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
|
N/A |
|
Date of First Enrollment (India)
|
22/06/2024 |
| 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="3"
Days="0" |
|
Recruitment Status of Trial (Global)
|
Not Yet Recruiting |
| 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
|
1) Prior permission of ethical
committee of GMC Bhavnagar will be taken.
2) Patient who comes to
dermatology OPD and whose clinical diagnosis of mucocutaneous
adverse drug reaction will be made ( those who
fulfilled the category of probable or possible
drug reaction as per Naranjo’s causality
assessment scale
3)The patient will be assessed as
per inclusion and exclusion criteria and will be included
after the consent is given by
patient
4)The patient will be examined
with full exposure of body in examination room and relevant
history taken
5) On the basis of history given by
the patient newest single largest lesion will be Identified
and dermoscopy will be performed with DERMLITE
DL5 dermoscope and the necessary
investigation(CBC,RFT,LFT,ELECTROLYTE,RBS)
will be carried out .Data will be entered
in excel file. analysis will be done by
using appropriate statistical software
|