A Phase II, Randomized, Double Blind, Placebo-Controlled Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients with Apparent Risk Factors of Nonalcoholic Steatohepatitis (NASH)
This is a phase II, randomized, double blind placebo-controlled, three-arm, parallel-group, intervention clinical trial evaluating anti-oxidant activity of Heptex; a herbal medicinal product of Aerial Parts of Phyllanthus niruri (Dukung Anak) and Fruits of Silybum marianum (Milk Thistle) in patients with apparent risk factors of NASH.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
SUPPORTIVE_CARE
Masking
TRIPLE
Enrollment
142
National Hepatology & Tropical Medicine Research Instistute
Cairo, Egypt
Tropical Medicine Department, Faculty of Medicine, Ain Shams University
Cairo, Egypt
explore the anti-oxidant activity of Heptex
assessed by the change in serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels in patients with apparent risk factors of NASH.
Time frame: 36 weeks
explore the hepatoprotective effect of Heptex
assessed by the change in Fibrosis score (F0 to F1: 2 to 7 kPa, F2: 7.5 to 10 kPa, F3: 10 to 14 kPa, F4: 14 kPa or higher) and by the occurrence of hepatic complications.
Time frame: 36 weeks
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