Effect of lycopene chaperoned with phosphatidylcholine on progression and outcomes of nonalcoholic steatohepatitis.

Phase 2

Recruiting

• Conditions: steatohepatitis; Alternative and Complementary Medicine - Herbal remedies; Oral and Gastrointestinal - Other diseases of the mouth, teeth, oesophagus, digestive system including liver and colon; Metabolic and Endocrine - Metabolic disorders

• Registration Number: ACTRN12615000386538
• Lead Sponsor: ycotec Ltd, Cambridge, UK

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Start: 2015-04-28
• Last Update Posted: 13 January 2020

Recruitment & Eligibility

• Status: Recruiting
• Sex: All
• Target Recruitment: 80

Inclusion Criteria

Patients with the definite or probable nonalcoholic steatohepatitis based on the results of computed tomography and laboratory tests.

Exclusion Criteria

1. Current alcohol use for a period of 3 consecutive months.
2. Patients with heart failure.
3. Anamnestic indication of long-term alcohol use in the past.
4. Patients with acute kidney injury at the time of enrollment
5. Patients with CKD (Chronic Kidney Disease) or with Creatinine level > 1 mg/dL.
5. Patient with platelet count <100.000/mm3

Study & Design

• Study Type: Interventional
• Study Design: Not specified