NCT05343780

Clinical Trial to Investigate the Anti-oxidant Activity of Heptex in Patients With Apparent Risk Factors of NASH

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)

• Status: Completed
• Phase: Phase 2
• Study type: Interventional
• Enrollment: 142 (actual)
• Sponsor: Natural Wellness Egypt · Industry
• Sex: All
• Age: 18 Years – 65 Years
• Healthy volunteers: Not accepted

Summary

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)

Detailed description

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.

Conditions

• Nonalcoholic Steatohepatitis

Interventions

Type	Name	Description
DRUG	Heptex	Dukung Anak 200 mg + Milk thistle 100 mg
OTHER	Rice bran	Placebo

Timeline

• Start date: 2019-05-08
• Primary completion: 2022-02-21
• Completion: 2022-02-21
• First posted: 2022-04-25
• Last updated: 2022-04-25

Locations

2 sites across 1 country: Egypt