| CTRI Number |
CTRI/2020/11/028927 [Registered on: 05/11/2020] Trial Registered Prospectively |
| Last Modified On: |
01/11/2020 |
| Post Graduate Thesis |
Yes |
| Type of Trial |
Observational |
|
Type of Study
|
Cohort Study |
| Study Design |
Other |
|
Public Title of Study
|
Trial to study findings in skin changes due to leprosy, remaining after completion of treatment in leprosy patients |
|
Scientific Title of Study
|
A prospective observational study to assess clinical,histopathological and bacteriological findings in treated cases of leprosy with persistent skin lesions after completing 6 months of paucibacillary and 12 months of multibacillary Multidrug therapy |
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
MEENAKSHI PATIAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER,Chandigarh |
| Address |
DEPARTMENT OF DERMATOLOGY,VENEREOLOGY AND LEPROLOGY
POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
SECTOR-12
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8351032856 |
| Fax |
|
| Email |
meenakshi.patial7@gmail.com |
|
Details of Contact Person
Scientific Query
|
| Name |
DR TARUN NARANG |
| Designation |
ASSOCIATE PROFESSOR |
| Affiliation |
PGIMER,Chandigarh |
| Address |
DEPARTMENT OF DERMATOLOGY,VENEREOLOGY AND LEPROLOGY
PGIMER
Sector-12
CHANDIGARH
Chandigarh
CHANDIGARH
160012
India |
| Phone |
9316063166 |
| Fax |
|
| Email |
narangtarun@yahoo.co.in |
|
Details of Contact Person
Public Query
|
| Name |
MEENAKSHI PATIAL |
| Designation |
JUNIOR RESIDENT |
| Affiliation |
PGIMER,Chandigarh |
| Address |
Department of Dermatology,venereology and leprology
PGIMER
Sector-12
Chandigarh
Chandigarh
CHANDIGARH
160012
India |
| Phone |
8351032856 |
| Fax |
|
| Email |
meenakshi.patial7@gmail.com |
|
|
Source of Monetary or Material Support
|
| POST GRADUATE INSTITUTE OF MEDICAL EDUCATION AND RESEARCH
SECTOR-12
CHANDIGARH |
|
|
Primary Sponsor
|
| Name |
none |
| Address |
nil |
| Type of Sponsor |
Other [nil] |
|
|
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 |
| Meenakshi patial |
PGIMER ,Chandigarh |
Department of Dermatology
New OPD block,5th floor Room no. 5015
PGIMER
Sector 12
Chandigarh
Chandigarh
CHANDIGARH |
8351032856
meenakshi.patial7@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: A305||Lepromatous leprosy, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
18.00 Year(s) |
| Age To |
80.00 Year(s) |
| Gender |
Both |
| Details |
1.Patients of either gender with age>18 years.
2.Leprosy patients with persistent skin lesions ,those who didn’t show desired response in
terms of no change in skin lesions or still showing signs of disease activity in terms of
infiltrated lesions or occurrence of new lesions, after completing 6 months of paucibacillary and 12 months of multibacillary MDT.
3.Patients who can give valid consent. |
|
| ExclusionCriteria |
| Details |
1.Patients with lepra reaction.
2.Those who are not willing to provide consent for the study. |
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
To observe the clinical,Slit skin smear findings, Histopathological findings in treated cases of
leprosy with persistent skin lesions after completion of 6 months of paucibacillary and 12 months of multibacillary WHO Multidrug therapy. |
Baseline |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
| To assess the frequency of drug resistance in these patients |
Baseline |
|
|
Target Sample Size
|
Total Sample Size="50"
Sample Size from India="50"
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)
|
15/11/2020 |
| 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="1"
Months="3"
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)?
Response - NO
|
|
Brief Summary
|
A Prospective observational study to assess the clinical,histopathological and bacteriological findings in treated cases of leprosy with persistent skin lesions after completion of 6 months of paucibacillary and 12 months of multibacillary multidrug therapy , that will be conducted in PGIMER,Chandigarh. For clinical findings , we will do clinical examination to assess morphology of skin lesion,the spectrum of leprosy. For histopathological findings ,skin biopsy will be done. For bacteriological findings , SSS will be done from the persistent skin lesion. We will assess the frequency of drug resistance in these patients. |