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Comparison of usefullness and safety of two drugs, Pentoxyphylline and Clofazimine, along with Prednisolone in Leprosy reaction

Efficacy and safety of Pentoxifylline and Prednisolone vs. Clofazimine and Prednisolone in the treatment of Type 2 Lepra reactions: a double blind randomized trial - L2PCS

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2013/05/003607
Enrollment
20
Registered
2013-05-03
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- Type 2 Lepra reaction occuring in patients suffering from Leprosy

Interventions

Intervention1: Pentoxyphylline and Prednisolone: Pentoxifylline 400mg in identical gelatin coated capsulated tablet form thrice daily for 12 consecutive weeks and Prednisolone 40 mg per day for two we

Sponsors

Medical College Kolkata
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1. All adult patients above 18 years of age presenting with type 2 lepra reaction 2. patients giving informed written consent

Exclusion criteria

Exclusion criteria: 1. Patient under 18 yrs. 2. Patient not giving informed written consent 3. Patients suffering from cardiac, hepatic, renal, neurological diseases, bleeding disorder, mental diseases, diabetes and/or immune-deficiencies related to HIV or not. 4. Patients having any or history ofcerebrovascular disease 5. Patients having history of hypersensitivity to methyl xanthine derivatives or Clofazimine. 6. patients showing abnormal baseline laboratory parameters 7. patients manifesting significant adverse effect of any drugs warranting discontinuation of therapy

Design outcomes

Primary

MeasureTime frame
Days required for complete remission of skin lesions in either treatment armTimepoint: 0, 1, 2, 4, 6, 8, 10, 12 weeks.

Secondary

MeasureTime frame
Days required for complete remission of systemic symptoms in either treatment armTimepoint: 0, 1, 2, 4, 6, 8, 10, 12 weeks;Laboratory safety parameters (Routine haemogram, LFT, Serum urea, creatinine, fasting blood glucoseTimepoint: 0, 12 weeks;Number and Interval of relapse (if any) in either treatment armTimepoint: 0, 1, 2, 4, 6, 8, 10, 12 weeks;Spontaneously reported and clinically elicited side effectsTimepoint: 1, 2, 4, 6, 8, 10, 12 weeks

Countries

India

Contacts

Public ContactAmrita Sil

Medical College, Kolkata

dockroy@rediffmail.com08013181558

Outcome results

None listed

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