Comparison of safety of 3 drugs which are Rifampicin 600mg , Clarithromycin 500mg and Minocycline 200mg given monthly once under supervision in treatment of leprosy versus standard MDT drug regimen in treatment of leprosy.

Comparative efficacy and safety of Rifampicin, Minocycline and Clarithromycin monthly pulse regimen versus standard WHO multidrug regimen in leprosy A randomized controlled study - NIL

Status

Recruiting

Phases

Phase 2Phase 3

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2025/03/082339

Enrollment

Registered

2025-03-17

Start date

Unknown

Completion date

Unknown

Last updated

2025-04-07

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

Conditions

Health Condition 1: L989- Disorder of the skin and subcutaneous tissue, unspecified

Interventions

Intervention1: RCM REGIMEN: RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg and Minocycline 200mg (RCM) regimen for 6 months in paucibacillary and 1

Eligibility

Inclusion criteria

Inclusion criteria: All new cases fulfilling cardinal signs of leprosy and biopsy proven patients above 18 years of age

Exclusion criteria

Exclusion criteria: Patients on steroids and other immunosuppressive drugs Pregnancy and lactation Pure neuritic leprosy Contraindications to the drugs in regimen.

Design outcomes

Primary

Measure	Time frame
To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg and Minocycline 200mg (RCM) in treatment of pauci and multi bacillary hansen is equally efficacious as WHO MDT in treatment of leprosyTimepoint: patients are assessed at baseline , at 6 months and 12 months of therapy	—

Secondary

Measure	Time frame
To prove RCM regimen comprising of monthly once supervised dose of Rifampicin 600mg ,Clarithromycin 500mg & Minocycline 200mg (RCM) in treatment of pauci & multi bacillary hansen has more safety profile with less side effects when compared to daily WHO MDT in treatment of leprosyTimepoint: patients are assessed at baseline , 6 months & 12 months of treatment	—

Countries

India

Contacts

Public ContactDr Minu s kani

KALINGA INSTITUTE OF MEDICAL SCIENCES

hemanta.kar@kims.ac.in9944217488

Outcome results

None listed

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