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Uniform treatment regimen for all types of leprosy patients

Uniform Multi Drug Therapy regimen for all leprosy patients

Status
Active, not recruiting
Phases
Phase 3
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2012/05/002696
Enrollment
3500
Registered
2012-05-25
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- Leprosy

Interventions

Intervention1: Rifampicin, Clofazimine and Dapsone: 600 mg Rifampicin every four weeks,300 mg Clofazimine every four weeks, 50 mg clofazimine once a day, 100 mg Dapsone once a day. This 4-weeks treat

Sponsors

WHOTDR
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: All the newly detected and treatment-naive leprosy patients will be eligible for inclusion. It is suggested the following categories of patients may be included in the study: easily accessible to the clinic, available for long-term follow-up and for receiving supervised dose of drug.

Exclusion criteria

Exclusion criteria: Newly detected pure neuritic patients, old patients, who are already receiving PB or MB-MDT, returned defaulters, and those who relapse subsequent to the earlier therapy will not be eligible for inclusion for this study.

Design outcomes

Primary

MeasureTime frame
Assess treatment response to 6 monthsâ?? Uniform MDT (UMDT) for all types of leprosy patients in terms of relapse rate not exceeding a maximum acceptable cumulative level of 8% at the end of 8 years Timepoint: Every one year post treatment

Secondary

MeasureTime frame
To assess acceptability, safety and compliance of UMDTTimepoint: At the end of treatment completion

Countries

China, India

Contacts

Public ContactDr Sanjay Mehendale

National Institute of Epidemiology

directorne@dataone.in04426136204

Outcome results

None listed

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