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治疗肝硬化和肝癌的组合物 (SB-1121) (SB-1121)

2026年11月4日 更新者:Nguyen Thi Trieu, MD

治疗肝硬化和肝癌的组合物

The composition treats cirrhosis and hepatocellular carcinoma (Hcc) at an early stage. The product is extracted from herbs, including Adenosma glutinosum extract, Eclipta prostrata extract, Phyllanthus urinaria extract, Impatiens balsamina extract, Ascorbic acid, pyridoxine 5-phosphate, L-Arginine hydrochloride, Pregnenolone acetate. These components have participated in repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, preventing liver cancer cell growth at an early stage. The composition supplements precursors which help the body strengthen antibodies and reduce the risk of inflammation, restore physiological and biochemical functions of liver cells after chronic inflammation.

研究概览

地位

完全的

条件

详细说明

The composition is fractionally extracted from herbs. Flavonoids, isoflavonoids, and pregnenolone combined with ascorbic acid, pyridoxine 5-phosphate, L-arginine act as the key compounds in the regeneration of fibrosis liver cells, remove scar tissue, stimulate and release growth hormones, prevent progression to Hcc and prevent Hcc recurrence.

The pharmaceutical ingredients involved in the composition are calculated to increase their effectiveness in preventing and curing cirrhosis and Hcc.

Currently, many preparations have been and are being studied to fight against cirrhosis and liver cancer globally. The effectiveness of this preparation is a new finding which has been proven over 5 years of follow-up.

Pregnenolone is a cortisol precursor. Cortisol plays an important role in several systems in the body, including the immune system(in the cycle of the immune system to produce B lymphocytes). This ingredient is used as a supplement to stabilize the endothelium, regulate the amount of cortisol within normal limits, and help the body produce B lymphocytes with a good response.

Kaempferol is a flavonoid that participates in cell protection against toxic proteins which were produced during prolonged inflammation; blocking the action and removing denatured proteins that change the parenchyma of liver cells. The selected flavonoids repaired the fibrotic structure of liver parenchyma after chronic inflammation. Ascorbic acid, pyridoxine 5-phosphate, and L-arginine help to facilitate biological functions in cell adhesion, synergize with flavonoids in cell membrane protection, structural repair, and liver cell regeneration.

Ascorbic acid, pyridoxine 5-phosphate act as enzymes that catalyze processes conveniently.

研究类型

介入性

注册 (实际的)

24

阶段

  • 第四阶段

扩展访问

得到正式认可的 出售给公众。 查看扩展访问记录。

联系人和位置

本节提供了进行研究的人员的详细联系信息,以及有关进行该研究的地点的信息。

学习地点

      • Ho Chi Minh City、越南、700000
        • Saigon Biopharma Company Limited

参与标准

研究人员寻找符合特定描述的人,称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。

资格标准

适合学习的年龄

18年 至 80年 (成人、年长者)

接受健康志愿者

是的

有资格学习的性别

全部

描述

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.

学习计划

本节提供研究计划的详细信息,包括研究的设计方式和研究的衡量标准。

研究是如何设计的?

设计细节

  • 主要用途:治疗
  • 分配:随机化
  • 介入模型:并行分配
  • 屏蔽:单身的

武器和干预

参与者组/臂
干预/治疗
实验性的:Cirrhosis

Experimental benefits in resistance to cirrhosis were observed in all patients who had previously received certain components of the treatment for cirrhosis SB-1121(1) for various therapeutic purposes.

The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.

其他名称:
  • 肝硬化/SB-1121
实验性的:Cirrhosis/Hcc "stable"

Experimental benefits in resistance to cirrhosis/Hcc were observed in all patients who had previously received certain components of the treatment for cirrhosis SB-1121(2) for various therapeutic purposes.

The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.

其他名称:
  • 肝硬化/Hcc/SB-1121

研究衡量的是什么?

主要结果指标

结果测量
措施说明
大体时间
Liver Stiffness Measurement (LSM)
大体时间:36 months

Liver stiffness is assessed by transient elastography to evaluate the degree of cirrhosis. Higher values indicate greater tissue stiffness. This measure reports the absolute liver stiffness values at the 36-month time point.

36 months

次要结果测量

结果测量
措施说明
大体时间
Liver Stiffness Measurement (LSM) for HCC Group
大体时间:36 months

Liver stiffness is assessed by transient elastography to evaluate tissue changes. This secondary outcome specifically analyzes the subgroup of participants who presented with hepatocellular carcinoma (HCC) within the study arms.

36 months

合作者和调查者

在这里您可以找到参与这项研究的人员和组织。

调查人员

  • 首席研究员:Tran Minh Cam Tu, Dr.、Saigon Biopharma Company Limited

出版物和有用的链接

负责输入研究信息的人员自愿提供这些出版物。这些可能与研究有关。

研究记录日期

这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查,以确保它们在发布到公共网站之前符合特定的质量控制标准。

研究主要日期

学习开始 (实际的)

2015年11月30日

初级完成 (实际的)

2025年10月10日

研究完成 (实际的)

2025年11月10日

研究注册日期

首次提交

2021年12月1日

首先提交符合 QC 标准的

2021年12月15日

首次发布 (实际的)

2022年1月5日

研究记录更新

最后更新发布 (实际的)

2026年11月6日

上次提交的符合 QC 标准的更新

2026年11月4日

最后验证

2026年10月1日

更多信息

与本研究相关的术语

计划个人参与者数据 (IPD)

计划共享个人参与者数据 (IPD)?

不

药物和器械信息、研究文件

研究美国 FDA 监管的药品

是的

研究美国 FDA 监管的设备产品

不

在美国制造并从美国出口的产品

是的

此信息直接从 clinicaltrials.gov 网站检索,没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求,请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改,我们的网站上也会自动更新.

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