Safety and Efficacy of Rifampicine 600 mg, Moxifloxacine 400mg and Minocycline 100 mg for leprosy patients: An open ended randomized trial

Safety and Efficacy of treatment regimen consisting of Rifampicin (600 mg), Moxifloxacin (400mg) and Minocycline (100 mg)-once a month supervisory dose to be given to leprosy patients ( 6 months to PB, 12 months to MB ) and comparing it with standard WHO regimen currently being given. - NIL

Status

Active, not recruiting

Phases

Phase 3Phase 4

Study type

Observational

Source

CTRI

Registry ID

CTRI/2019/02/017812

Enrollment

1820

Registered

2019-02-25

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: A309- Leprosy, unspecified

Interventions

Control Intervention1: RMM: Rifampicine 600 (once a month supervised) Moxifloxacine 400 (once a month supervised) Minocycline 100 (once a month supervised)

Eligibility

Inclusion criteria

Inclusion criteria: New untreated leprosy case

Exclusion criteria

Exclusion criteria: Any patient condition (Pregnancy, Lactation, Co-infection TB,Diebetes, Hypertension, Peripheral Vascular Diseases, Choronic Artery Diseses) that would be expected to confound with patients monitoring would not be included in the study. Patients who present with reaction or disability needing steroid would also not be included

Design outcomes

Primary

Measure	Time frame
Cure of patients, Relapses, developement of disability if any, DefaultTimepoint: 6 months 12 months 24 months	—

Secondary

Measure	Time frame
Reactions and side effectsTimepoint: 12 months 24 months 36 months	—

Countries

India

Contacts

Public ContactDr Anil Kumar

National JALMA Institute for Leprosy

dranil250158@gmail.com9719459437

Outcome results

None listed

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