Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Therapeutic Composition and Mechanism of Action. The core of this pharmaceutical composition is a synergistic complex of Ascorbic Acid, L-Arginine Hydrochloride, and a high-potency flavonoid blend (Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, and Rutin). These compounds function as pivotal agents in the protection of hepatocyte membranes, mitigation of oxidative stress, and preservation of the liver's structural integrity.
Structural Regeneration and Fibrosis Reversal. The selected flavonoids specifically target the restoration of liver parenchyma by neutralizing toxic proteins produced during prolonged chronic inflammation. By blocking and removing denatured proteins that alter hepatic tissue, the composition facilitates the remodeling of fibrotic structures and the removal of scar tissue. Ascorbic Acid and L-Arginine act as essential catalysts, enhancing cell adhesion and synergizing with flavonoids to accelerate the regeneration of healthy liver cells.
Immune Modulation and Endothelial Stability. This preparation serves as a critical supplement to stabilize the endothelium and maintain cortisol levels within physiological limits. A key breakthrough in this formulation is its ability to stimulate the production and optimize the response of B lymphocytes, strengthening the body's adaptive immune system. Furthermore, the composition is designed to stimulate the release of growth hormones, fostering an internal environment conducive to cellular repair.
Clinical Significance and Oncogenic Prevention: While numerous therapies for hepatitis and cirrhosis are under global investigation, the efficacy of this specific formulation represents a significant advancement, validated by 8 years of longitudinal follow-up data. The precise ratios of these pharmaceutical ingredients are calculated to maximize their therapeutic impact in preventing and treating acute/chronic hepatitis and advanced cirrhosis. Crucially, the composition effectively arrests the progression to Hepatocellular Carcinoma (HCC) and significantly reduces the risk of post-treatment recurrence.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Tenofovir 300mg + SB Flavon | Experimental | Enhanced resistance to Hepatitis B Virus was demonstrated across all patient subgroups-including those with cirrhosis and HCC-following the administration of a Tenofovir and SB Flavon regimen. |
|
| Tenofovir 300mg | Experimental | While Tenofovir monotherapy provided baseline experimental benefits in HBV resistance, the integration of SB Flavon resulted in superior clinical outcomes... |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Flavonoid | Drug | The daily maintenance, Tenofovir 150mg + SB Flavon 1345mg dose is to be taken 2 times a day, 1 tablet each time. The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma at an early stage. The product is Acid ascorbic, L-Arginine hydrochloride, Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, Rutin. Use these ingredients to protect liver cell membranes, preventing the growth of HBV in the body. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 | Evaluation of hepatic fibrosis regression using Transient Elastography (Fibroscan). The study measures the success rate of transitioning from advanced cirrhosis (Stage F3- F4, typically >12.5 kPa) to lower fibrosis stages (F2 or F1). | Baseline, Year 1, Year 2, and Year 3. |
| Incidence of Hepatocellular Carcinoma (HCC) Development | The rate of participants progressing to HCC. This metric is monitored via serum Alpha-Fetoprotein (AFP) levels and periodic diagnostic imaging every six months (Ultrasound/CT/MRI). Success is defined as the absence of malignant transformation or recurrence. | Every 6 months up to 3 years |
| Measure | Description | Time Frame |
|---|---|---|
| Number of participants with improvement in hepatic synthetic function measured via serum Albumin levels | Assessment of the liver's ability to synthesize proteins by measuring serum Albumin levels. Unit of Measure: g/L | Every 6 months up to 3 years. |
| Number of participants with improvement in hepatic synthetic function measured via International Normalized Ratio (INR) |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Nguyen Thi Trieu, MD | Trieu, Nguyen Thi, M.D. | Study Director |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Saigon Biopharma LLC | Wilmington | Delaware | 19801-6601 | United States | ||
| Saigon Biopharma Company Limited |
Not provided
| Type | Includes Protocol | Includes SAP | Includes ICF | Document Label | Document Date | Document Uploaded Date | Document File Name |
|---|---|---|---|---|---|---|---|
| Prot | Yes | No | No | Study Protocol | May 16, 2026 | Jun 3, 2026 | Prot_000.pdf |
| SAP | No | Yes | No | Statistical Analysis Plan | May 16, 2026 | Jun 3, 2026 | SAP_001.pdf |
Not provided
| ID | Term |
|---|---|
| D006509 | Hepatitis B |
| ID | Term |
|---|---|
| D000086982 | Blood-Borne Infections |
| D003141 | Communicable Diseases |
| D007239 | Infections |
| D018347 | Hepadnaviridae Infections |
Not provided
Not provided
| ID | Term |
|---|---|
| D005419 | Flavonoids |
| D000068698 | Tenofovir |
| ID | Term |
|---|---|
| D002867 | Chromones |
| D001578 | Benzopyrans |
| D011714 | Pyrans |
| D006573 | Heterocyclic Compounds, 1-Ring |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
|
|
| Tenofovir | Drug | The daily maintenance, Tenofovir 300mg dose is to be taken 1 time a day, 1 tablet each time. The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma. |
|
Assessment of the liver's coagulation factor synthesis capacity by measuring the International Normalized Ratio (INR). Unit of Measure: Ratio (or Unitless) |
| Every 6 months up to 3 years. |
| Change in liver stiffness measurement via transient elastography | Evaluation of liver tissue stiffness using ultrasound-based sound waves to monitor the progression or reversal of cirrhosis. Unit of Measure: kilopascals (kPa) | Every 6 months up to 3 years. |
| Hồ Chí Minh |
| Ho Chi Minh City |
| 700000 |
| Vietnam |
| D004266 |
| DNA Virus Infections |
| D014777 | Virus Diseases |
| D006525 | Hepatitis, Viral, Human |
| D006505 | Hepatitis |
| D008107 | Liver Diseases |
| D004066 | Digestive System Diseases |
| D006571 |
| Heterocyclic Compounds |
| D006574 | Heterocyclic Compounds, 2-Ring |
| D000072471 | Heterocyclic Compounds, Fused-Ring |
| D063065 | Organophosphonates |
| D009943 | Organophosphorus Compounds |
| D009930 | Organic Chemicals |
| D000225 | Adenine |
| D011687 | Purines |