CompletedPhase 4

Inhibition of HBV Replication and Biological Reversal of Cirrhosis (F3-F4) and HCC by Flavonoids

United States, Vietnam134 participantsStarted 2015-11-30

Plain-language summary

SB Flavonoids for Advanced Liver Disease ManagementSB Flavonoids represents a multi-target therapeutic composition engineered for the comprehensive management of Hepatitis (Acute and Chronic), Advanced Cirrhosis (F3)-(F4), and Early-stage Hepatocellular Carcinoma (HCC).The formulation features a synergistic complex of Ascorbic Acid, L-Arginine Hydrochloride, and a high-potency flavonoid blend, including Kaempferol, Urinariaflavone, Quercetin, Rutin, and 5,6-dihydroxy-7,8,4'-trimethoxy-flavone. This combination exerts a powerful hepatoprotective and antifibrotic effect by: Structural Regeneration: Promoting the repair and regeneration of functional liver parenchyma while stabilizing hepatocyte membranes to mitigate oxidative stress. Bioreversal of Fibrosis: Actively inhibiting the activation of pro-fibrogenic cells (hepatic stellate cells) and remodeling the extracellular matrix to reverse advanced (F3)-(F4) fibrosis. Oncogenic Suppression: Inhibiting the proliferation of malignant cells to prevent the progression of early-stage liver cancer. Homeostatic Restoration: Providing essential molecular precursors to strengthen the host's immune surveillance, reduce chronic inflammation, and restore the liver's physiological and biochemical homeostasis.By addressing both viral-induced damage and structural degradation, SB Flavonoids offers a novel pathway for restoring hepatic function and systemic health in patients with progressive liver diseases.

Who can participate

Age range

18 Years – 80 Years

Sex

ALL

See this in plain English?

AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.

Inclusion Criteria: * All patients with underlying medical conditions who have been taking medications for these conditions. * Patients with AIDS, HIV, HBV, HCV, and patients with co-infections. * The cancer patients are stable. * Patients with congenital or acquired immunodeficiency. Exclusion Criteria: * Unstable cancer patients. * Decompensated cirrhosis.

Questions worth asking your doctor

Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.

1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?

Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.

Questions for the trial coordinator

The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.

1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?

A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.

What they're measuring

Reduction in Liver Stiffness Measurement (LSM) as an Indicator of Fibrosis The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis

Timeframe: Baseline, Year 1, Year 2, and Year 3.

Incidence of Hepatocellular Carcinoma (HCC) Development

Timeframe: Every 6 months up to 3 years

Trial details

NCT IDNCT07084948

SponsorTrieu, Nguyen Thi, M.D.

Sponsor typeINDIV

Study typeINTERVENTIONAL

Primary completion2025-10-10

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