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Nonalcoholic SteatohepatitisPhase 2PHYLLANTEXNCT05343780

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

A Phase 2 study testing Heptex and Rice bran in people with Nonalcoholic Steatohepatitis, run by Natural Wellness Egypt at 2 sites in Egypt.

Completed

Finished. The study has ended and is not enrolling. Results may be posted on the official record.

Official record
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Trial 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) Read more about this study

Who is it for?
Ages 18 to 65 years
Conditions the study is for
Nonalcoholic Steatohepatitis
What is being tested?
Heptex and Rice bran
Type of treatment
Pill or oral medicine
Could I receive a placebo?
Yes, some participants may receive a placebo
How many people
142 participants
Where
2 sitesEgypt
Study dates
8 May 2019to 21 Feb 2022
Phase
Phase 2
Are there results?
None posted in the registry

Key requirements

Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.

  • Ages 18 to 65 years
  • All sexes
  • No healthy volunteers
  • Adult, Older adult

Who may be able to join

  • 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;
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  • 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.

Who cannot join

  • 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.
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  • 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.
  • Patients with history of clinically-significant illness or any other major medical disorder that may interfere with subject treatment, assessment, or compliance with the protocol.
  • Receipt of an investigational drug within 6 months prior to screening, or active enrolment in another investigational medication or device trial.
  • Patients with any chronic illness or prior treatment which in the opinion of the investigator should preclude participation in the trial.
  • Inability to understand and cooperate with the investigators or to give valid consent.

Trial locations and contacts

2 sites in 1 country.

Egypt2 sites

  • National Hepatology & Tropical Medicine Research Instistute

    Cairo

  • Tropical Medicine Department, Faculty of Medicine, Ain Shams University

    Cairo

Other trials in Egypt

About this study

Official title: 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)

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)

Read the 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.

Being tested
Heptex, Rice bran
Keywords
NASH
Medical subject headings
Non-alcoholic Fatty Liver Disease

What participants receive

What participants receive. In a randomised study each person is assigned to one group by chance.

  • HeptexDrug

    Dukung Anak 200 mg + Milk thistle 100 mg

  • Rice branOther

    Placebo

Study groups in NCT05343780
Study groupRoleWhat they receive
PlaceboPlacebo comparatorPlacebo (Rice bran) in 2 capsules size 1, administered PO TID on empty stomach with plenty of water.
Receives: Other: Rice bran
Heptex-low doseExperimentalLow 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.
Receives: Drug: Heptex
Heptex-high doseExperimentalHigh 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.
Receives: Drug: Heptex

What is being measured

The primary outcome is the main question the study is designed to answer.

  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.

    Measured: 36 weeks

Secondary outcomes (1)

  1. 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.

    Measured: 36 weeks

Timeline

From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.

  1. First posted25 Apr 2022
  2. Study start8 May 2019
  3. Primary completion21 Feb 2022
  4. Study completion21 Feb 2022

Resources

More details

For doctors and researchers: how the study is designed, who runs it, and its registry IDs.

Study design
Study type
Interventional
Phase
Phase 2
Primary purpose
Supportive care
Allocation
Randomised
Intervention model
Parallel groups
Masking
Triple blind
Who is masked
Participant, Care provider, Investigator
Enrolment
142 participants (actual)
IDs, dates and publications
ClinicalTrials.gov ID
NCT05343780
Sponsor's protocol ID
NW_PHYLLANTEX_17052018
Acronym
PHYLLANTEX
Status last verified
Apr 2022
First submitted
15 May 2019
Last updated
25 Apr 2022
Results posted
No
Data monitoring committee
No
FDA-regulated drug
No
FDA-regulated device
No
Individual data sharing
Undecided

Publications

  • 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.

    PubMed 39789561

Questions about this trial

What is this clinical trial studying?

A Phase 2 study testing Heptex and Rice bran in people with Nonalcoholic Steatohepatitis, run by Natural Wellness Egypt at 2 sites in Egypt.

The full registered description is in the About this study section and the official record.

Who may be eligible to take part?

The sponsor lists 13 inclusion and 19 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.

Is this clinical trial currently recruiting?

The record says: finished, as of the sponsor's last update on 25 Apr 2022. Status can change between updates, so confirm with the study contact before making plans.

Where is the study taking place?

The record lists 2 sites in Egypt. Whether a site is taking part right now should be confirmed with that site. See every site.

What are the possible benefits and risks?

They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.

What does this phase mean?

Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.

Not every study follows the same path, and some studies (observational studies, device studies) have no phase.

Are results available for this study?

The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.

How can a doctor refer a patient or contact the research team?

The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.

What does the primary outcome measure?

explore the anti-oxidant activity of Heptex (time frame: 36 weeks). It is what the study was designed to measure, not a finding.

Where can I read the original study information?

On the ClinicalTrials.gov record for NCT05343780, which also lists 1 linked publication.

Does a listing mean the treatment is approved or proven to work?

No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.

How often is this information updated?

AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 25 Apr 2022.

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