A study to assess if molecular analysis of certain leprosy specific genes shall be helpful in monitoring response to therapy in leprosy

Not Applicable

• Conditions: Health Condition 1: null- Newly detected untreated cases of Hansens DiseaseHealth Condition 2: L088- Other specified local infections of the skin and subcutaneous tissue

• Registration Number: CTRI/2017/11/010609
• Lead Sponsor: IADVL Research Grants

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 24 November 2021

Recruitment & Eligibility

• Status: Open to Recruitment
• Sex: Not specified
• Target Recruitment: 0

Inclusion Criteria

All newly diagnosed untreated Hansenâ??s disease patients coming to the dermatology out-patient department of our hospital dyring the study period

Exclusion Criteria

i) Hansenâ??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 Hansenâ??s disease

Study & Design

• Study Type: Observational
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
strength of expression of 16S RNA and 18 kDa antigen genes <br/ ><br>Morphological indexTimepoint: Baseline at 6 and 12 months of multidrug therapy

Secondary Outcome Measures

Name	Time	Method
<br/ ><br>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. <br/ ><br>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 <br/ ><br> <br/ ><br>Timepoint: Baseline <br/ ><br>at 6 and at 12 months of therapy