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

NCT05343780 | Completed Phase 2

• 1 other identifier: NW_PHYLLANTEX_17052018
• Study Type: interventional
• Target: 142
• Locations: 1 country
• Sites: 2

Brief 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)

Conditions

Nonalcoholic Steatohepatitis

Keywords

NASH

Outcome Measures

Primary Outcomes (1)

• 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.

  36 weeks

Secondary Outcomes (1)

• explore the hepatoprotective effect of Heptex

  36 weeks

Other Outcomes (1)

• To explore the lipid-lowering effect of Heptex

  36 weeks

Study Arms (3)

Placebo

PLACEBO COMPARATOR

Placebo (Rice bran) in 2 capsules size 1, administered PO TID on empty stomach with plenty of water.

Other: Rice bran

Heptex-low dose

EXPERIMENTAL

Low dose The contents of one capsule of Heptex is equally distributed and inserted into 2 capsules size 1, administered PO TID on empty stomach with plenty of water.

Drug: Heptex

Heptex-high dose

EXPERIMENTAL

High dose The contents of two capsule of Heptex is equally distributed and inserted into 2 capsules size 1, administered PO TID on empty stomach with plenty of water.

Drug: Heptex

Interventions

Heptex DRUG

Dukung Anak 200 mg + Milk thistle 100 mg

Heptex-high dose; Heptex-low dose

Rice bran OTHER

Placebo

Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• Male or female aged between 18 and 65 years.
• Both male and female patients who have childbearing potential must agree to practice an acceptable method of birth control during the study and for at least 6 months after the cessation of treatment; such contraceptive methods must include at least one barrier method.
• Controlled Attenuation Parameter (CAP)-confirmed hepatic steatosis.
• Patients with elevated serum aspartate aminotransferase (AST) and alanine aminotransferase (ALT) levels but less than 2.5 times the upper limit of the normal range.
• Liver fibrosis stage F1-F2 as diagnosed by the FibroScan liver stiffness measurement of 5-10 kPa.
• Liver condition according the following criteria;
• Serum albumin \> 3 g/dl
• INR \< 2
• No ascites on ultrasound
• No documented or suspected hepatic encephalopathy
• Willing to stop any other liver support and hepatoprotective medications throughout study duration.
• Able and willing to provide written informed consent.
• Able and willing to complete all study visits and procedures, including compliance with the requirements and restrictions listed in the consentform.

You may not qualify if:

• Pregnant or lactating women.
• Patients with BMI \> 40 Kg/m2 or BMI \< 18.5 Kg/m2.
• Serum creatinine \> 1.5 x ULN OR creatinine clearance (GFR) \< 60 mL/minute.
• Platelet count \< 75,000/mm3.
• Uncontrolled diabetes mellitus as evident by HbA1c ≥ 8.5%.
• Patients who are currently receiving Thiazolidinediones.
• Patients with ischemic heart disease (IHD).
• History of parenteral nutrition.
• History of liver transplant.
• Viral hepatitis, drug-induced liver injury, metabolic liver disease or auto-immune liver disease.
• Liver cancer or serum alpha-fetoprotein (AFP) \>100ng/ml. Patients with an AFP between 50 and 100ng/ml may be included as long as a liver ultrasound within 3 months of screening, or at screening, shows no evidence of potential hepatocellular cancer.
• Use of drugs known to induce steatosis (valproate, amiodarone or prednisone) or to affect body weight and carbohydrate metabolism.
• Use of drugs known to alter liver enzymes.
• Allergy or allergic history to any of the drug components.
• History of alcohol abuse as assessed by the investigator within the past 2 years, or an alcohol use pattern that may interfere with the patient's study compliance. Patients must have abstained from alcohol for at least 6 months prior to study start.

Sponsors & Collaborators

• Natural Wellness Egypt: lead
• Ain Shams University: collaborator
• National Hepatology & Tropical Medicine Research Institute: collaborator

Study Sites (2)

National Hepatology & Tropical Medicine Research Instistute

Cairo, Egypt

Location

Tropical Medicine Department, Faculty of Medicine, Ain Shams University

Cairo, Egypt

Location

Related Publications (1)

• Shaker MK, Hassany M, Eysa B, Adel A, Zidan A, Mohamed S. The activity of a herbal medicinal product of Phyllanthus niruri and Silybum marianum powdered extracts (Heptex(R)) in patients with apparent risk factors for nonalcoholic steatohepatitis: a phase II, multicentered, randomized, double-blind, placebo-controlled clinical trial. BMC Complement Med Ther. 2025 Jan 9;25(1):8. doi: 10.1186/s12906-024-04692-y.

  PMID: 39789561 DERIVED

MeSH Terms

Conditions

Non-alcoholic Fatty Liver Disease

Condition Hierarchy (Ancestors)

Fatty Liver; Liver Diseases; Digestive System Diseases

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: TRIPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR
• Masking Details: Double blinded
• Purpose: SUPPORTIVE CARE
• Intervention Model: PARALLEL
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: May 15, 2019
• First Posted: April 25, 2022
• Study Start: May 8, 2019
• Primary Completion: February 21, 2022
• Study Completion: February 21, 2022
• Last Updated: April 25, 2022

Record last verified: 2022-04

Locations

EG (2)