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A study to compare the usefulness and safety of Clofazimine and Minocycline in patients with repeated episodes of erythema nodosum Leprosum

A prospective, randomized control study to compare the effectiveness and safety of minocycline and clofazimine in patients of chronic and recurrent erythema nodosum leprosum

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2018/07/014965
Enrollment
60
Registered
2018-07-19
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- clinically diagnosed cases of erythema nodosum leprosum Health Condition 2: A305- Lepromatous leprosy

Interventions

Intervention1: Minocycline: 100 mg orally once a day for 3 months Control Intervention1: Clofazimine: 100 mg orally thrice a day for 3 months

Sponsors

None
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. Chronic and recurrent ENL cases of leprosy regardless of age, sex and treatment status with MDT 2. Patients not on treatment with paracetamol, pentoxifylline, colchicine, methotrexate, azathioprine, TNF inhibitors etc., 3. Patients who can give valid consent. 4. Willing for monthly follow-up visits for at least 6 months

Exclusion criteria

Exclusion criteria: 1. Pregnant and lactating mothers 2. Patients allergic to tetracyclines, clofazimine 3. Patients with HIV, Hepatitis B and Hepatitis C 4. Inability to come for monthly follow up visits for 6 months 5. Those who cannot provide consent for the study 6. Patients with cardiac, hepatic, renal disease, neurological diseases, bleeding disorder, mental diseases, cerebrovascular diseases and showing abnormal baseline laboratory parameters

Design outcomes

Primary

MeasureTime frame
The primary outcome measure will be the number of ENL recurrence episodes per patient for each treatment arm, both during treatment period (week 1â??12) and the follow-up period (6 months). An episode of ENL will be defined as the occurrence of ENL requiring the institution or change of treatment (such as an increase in dosage or frequency of treatment or the addition of or switching to another drug).Timepoint: At the end of 6 months follow up—

Secondary

MeasureTime frame
1. Mean time to ENL recurrence after initial control; 2. Severity of ENL at recurrence; 3. Amount of additional prednisolone required by patients over the study period; 4. Frequency of adverse events for patients in each treatment arm; and 5. The difference in score in Quality of Life assessment (SF36) between start and end for patients in each treatment arm Timepoint: At the end of 6 months follow up—

Countries

India

Contacts

Public ContactDr Tarun Narang

PGIMER, Chandigarh

narangtarun@yahoo.co.in9316063166

Outcome results

None listed

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