| CTRI Number |
CTRI/2017/11/010609 [Registered on: 23/11/2017] Trial Registered Prospectively |
| Last Modified On: |
18/11/2019 |
| Post Graduate Thesis |
No |
| Type of Trial |
Observational |
|
Type of Study
|
Follow Up Study |
| Study Design |
Other |
|
Public Title of Study
|
A study to assess if molecular analysis of certain leprosy specific genes shall be helpful in monitoring response to therapy in leprosy
|
|
Scientific Title of Study
|
A study of RT-PCR quantification of 16S RNA and 18-kDa antigen gene targets in assessing the efficacy of multi-drug therapy in leprosy
|
| Trial Acronym |
|
|
Secondary IDs if Any
|
| Secondary ID |
Identifier |
| NIL |
NIL |
|
|
Details of Principal Investigator or overall Trial Coordinator (multi-center study)
|
| Name |
Ranugha PSS |
| Designation |
Assistant Professor Department of Dermatology |
| Affiliation |
JSS Medical College and Hospital |
| Address |
Department of Dermatology,
JSS Hospital
Room nos 1011-17
MG Road
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9880375157 |
| Fax |
|
| Email |
ranughapss@jssuni.edu.in |
|
Details of Contact Person
Scientific Query
|
| Name |
Ranugha PSS |
| Designation |
Assistant Professor Department of Dermatology |
| Affiliation |
JSS Medical College and Hospital |
| Address |
Department of Dermatology
JSS Hospital
Room nos 1011-17
MG Road
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9880375157 |
| Fax |
|
| Email |
ranughapss@jssuni.edu.in |
|
Details of Contact Person
Public Query
|
| Name |
Ranugha PSS |
| Designation |
Assistant Professor Department of Dermatology |
| Affiliation |
JSS Medical College and Hospital |
| Address |
Department of Dermatology
JSS Hospital
Room nos 1011-17
MG Road
Mysore
Mysore
KARNATAKA
570004
India |
| Phone |
9880375157 |
| Fax |
|
| Email |
ranughapss@jssuni.edu.in |
|
|
Source of Monetary or Material Support
|
| Name of source
Indian Association of Dermatologists Venereologists and Leprologists(IADVL) Research Grants
Address
Dr. Shyamanta Barua,
Honorary Secretary General,
Indian Association of Dermatologists, Venereologists & Leprologists,
IADVL National Headquarters,
4772-73 Pvt No.,T-3 & T-4, 3rd Floor,
23 Bharat Ram Road, Darya Ganj,
New Delhi-110002.
|
|
|
Primary Sponsor
|
| Name |
IADVL Research Grants |
| Address |
Dr. Shyamanta Barua,
Honorary Secretary General,
Indian Association of Dermatologists, Venereologists & Leprologists,
IADVL National Headquarters,
4772-73 Pvt No.,T-3 & T-4, 3rd Floor,
23 Bharat Ram Road, Darya Ganj,
New Delhi-110002. |
| Type of Sponsor |
Other [Indian Association of Deramtologists Venereologists and Leprologists(IADVL) Research Grantsi] |
|
|
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 |
| Ranugha PSS |
JSS Hospital |
Department of Dermatology
Room nos. 1011-1017
JSS Hospital
MG Road
MYSORE
Mysore
KARNATAKA |
9880375157
9880375157
ranughapss@jssuni.edu.in |
|
|
Details of Ethics Committee
|
| No of Ethics Committees= 1 |
| Name of Committee |
Approval Status |
| JSS MEDICAL COLLEGE INSTITUITIONAL ETHICAL COMMITTEE |
Approved |
|
|
Regulatory Clearance Status from DCGI
|
|
Health Condition / Problems Studied
Modification(s)
|
| Health Type |
Condition |
| Patients |
Newly detected untreated cases of Hansens Disease, (1) ICD-10 Condition: L088||Other specified local infections of the skin and subcutaneous tissue, |
|
|
Intervention / Comparator Agent
|
|
|
Inclusion Criteria
|
| Age From |
1.00 Year(s) |
| Age To |
90.00 Year(s) |
| Gender |
Both |
| Details |
All newly diagnosed untreated Hansen’s disease patients coming to the dermatology out-patient department of our hospital dyring the study period
|
|
| ExclusionCriteria |
| Details |
i) Hansen’s disease patients on treatment or those who have completed treatment
ii) Doubtful cases not confirmed by biopsy or SSS
iii) Cases of pure neuritic Hansen’s disease
|
|
|
Method of Generating Random Sequence
|
Not Applicable |
|
Method of Concealment
|
Not Applicable |
|
Blinding/Masking
|
Not Applicable |
|
Primary Outcome
|
| Outcome |
TimePoints |
strength of expression of 16S RNA and 18 kDa antigen genes
Morphological index |
Baseline at 6 and 12 months of multidrug therapy |
|
|
Secondary Outcome
|
| Outcome |
TimePoints |
1. To assess the change in RT-PCR expression of 16S RNA and 18-kDa genes in skin biopsy specimens at 6 and 12 months of chemotherapy.
2. To compare the percentage change in RT-PCR values of 16S RNA and 18-kDa genes with percentage reduction in Morphological index at 6 and 12 months post treatment in smear positive patients
|
Baseline
at 6 and at 12 months of therapy |
|
|
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)
|
11/12/2017 |
| 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="3"
Months="0"
Days="0" |
Recruitment Status of Trial (Global)
Modification(s)
|
Not Applicable |
| Recruitment Status of Trial (India) |
Open to Recruitment |
|
Publication Details
|
|
|
Individual Participant Data (IPD) Sharing Statement
|
Will individual participant data (IPD) be shared publicly (including data dictionaries)?
|
|
Brief Summary
|
This is a prospective clinical study to compare the baseline and post treatment RT-PCR quantifiucation values of 16S RNA and 18kDa antigen gene targets in leprosy patients. Fifty consecutive newly diagnosed untreated Hansen’s disease patients coming to our hospital during the study period shall be recruited for the study. Baseline Slit skin smear for Baceriological and morphological index, skin biopsy for histopathalogy and molecular analysis shall be done. All patients shall be started on Multidrug therapy for Leprosy as per WHO guidelines. Skin smear and skin biopsy for RT-PCR analysis shall be repeated at 6 and 12 months of therapy in patients with positive baseline values. Hypothesis: RT-PCR analysis of strength of expression of 16 S RNA and 18 kDa gene expression is effective in monitoring response to therapy in Leprosy. |