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

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

Status
Recruiting
Phases
Unknown
Study type
Observational
Source
CTRI
Registry ID
CTRI/2017/11/010609
Enrollment
50
Registered
2017-11-23
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

None listed

Sponsors

IADVL Research Grants
Lead Sponsor

Eligibility

Inclusion criteria

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

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

Design outcomes

Primary

MeasureTime frame
strength of expression of 16S RNA and 18 kDa antigen genes Morphological indexTimepoint: Baseline at 6 and 12 months of multidrug therapy

Secondary

MeasureTime frame
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 Timepoint: Baseline at 6 and at 12 months of therapy

Countries

India

Contacts

Public ContactRanugha PSS

JSS Medical College and Hospital

ranughapss@jssuni.edu.in9880375157

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026