A clinical trial to study the efficacy of steroids versus steroids and pentoxifylline in the treatment of patients with severe acute alcoholic hepatitis

Phase 4

• Conditions: Severe alcoholic hepatitis (defined by modified Maddreys Discriminant Function ≥ 32)

• Registration Number: CTRI/2009/091/000876
• Lead Sponsor: Dr Sandeep Sidhu ProfessorDepartment of GastroenterologyDMC and Hospital, Ludhiana. PunjabTel: 0161- 2402855 Cell: 9814025085, Fax: 0161-2302620Email- dmcgastro@in.com

Brief Summary

This study is a randomized single centre trail evaluating the difference in the efficacy of a combination of corticosteroids (tab Prednisolone 40 mg/day) and pentoxifylline (400 mg, thrice a day, per oral) versus corticosteroids alone for reducing short term (28 days) mortality in patients with severe alcoholic hepatitis. The primary outcome measures will be reduction in short term mortality, while the secondary outcome measures would be improvement in hepatic function.

Detailed Description

Not available

Recruitment & Eligibility

• Sex: Not specified
• Target Recruitment: 70

Inclusion Criteria

Patients of alcoholic hepatitis with modified Maddrey?s Discriminant factor (DF) ≥ 32.

Exclusion Criteria

Improvement in DF with symptomatic treatment for 5-7 daysPositive viral serology for HAV, HBV, HCV or HEVConcomitant bacterial or fungal infectionsActive gastrointestinal haemorrhageSevere cardiovascular or pulmonary diseasesNeoplastic and other inflammatory conditions.

Study & Design

• Study Type: Not specified
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Reduction in Mortality	4 weeks

Secondary Outcome Measures

Name	Time	Method
Improvement in Hepatic functions	4 weeks

Trial Locations

Locations (1)

DMC and Hospital; 🇮🇳 Ludhiana, PUNJAB, India

DMC and Hospital

🇮🇳Ludhiana, PUNJAB, India

Dr Sandeep Sidhu

Principal investigator

dmcgastro@in.com