Therapeutic Efficacy of SB Flavon in the Treatment of Advanced (F3-F4) HBV-related Cirrhosis and Hepatocellular Carcinoma
试验速览
- 阶段
- 4 期
- 状态
- 已完成
- 发起方
- 入组人数
- 134
- 试验地点
- 4
- 主要终点
- Quantification of HBV-DNA, SGPT, SGOT. The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Supportive Care
- 盲法
- Single (Participant)
入排标准
- 年龄范围
- 18 Years 至 80 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •Unstable cancer patients.
- •Decompensated cirrhosis.
研究组 & 干预措施
Tenofovir 300mg + SB Flavon
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.
干预措施: Flavonoid (Drug)
Tenofovir 300mg + SB Flavon
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.
干预措施: Tenofovir (Drug)
Tenofovir 300mg
While Tenofovir monotherapy provided baseline experimental benefits in HBV resistance, the integration of SB Flavon resulted in superior clinical outcomes...
干预措施: Tenofovir (Drug)
结局指标
主要结局
Quantification of HBV-DNA, SGPT, SGOT. The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis
时间窗: 36 months
HBV injure healthy liver cells, causing cell death and inflammation. Healthy liver tissue is replaced with scar tissue and the liver is damaged.
次要结局
- The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)(36 months)