Composition for Treating Cirrhosis and Liver Cancer (SB-1121)

Cirrhosis of the Liver Clinical Trial

— SB-1121  

Official title:

Composition for Treating Cirrhosis and Liver Cancer

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05178303
• Other study ID #: Cirrhosis and Hcc
• Status: Completed
• Phase: N/A
• Start date: November 30, 2015
• Est. completion date: November 10, 2021

Study information

• Verified date: December 2021
• Source: Trieu, Nguyen Thi, M.D.
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial Summary

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.

Description:

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.

Recruitment information / eligibility

• Status: Completed
• Enrollment: 134
• Est. completion date: November 10, 2021
• Est. primary completion date: October 10, 2021
• Accepts healthy volunteers: Accepts Healthy Volunteers
• Gender: All
• Age group: 18 Years to 80 Years

Eligibility

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.

Related Conditions & MeSH terms

• Cirrhosis of the Liver
• Fibrosis
• Liver Cirrhosis
• Liver Neoplasms

Intervention

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

Locations

Country	Name	City	State
Vietnam	Saigon Biopharma Company Limited	Ho Chi Minh City

Sponsors (1)

Lead Sponsor	Collaborator
Nguyen Thi Trieu, MD

Country where clinical trial is conducted

Vietnam, 

References & Publications (8)

14. Physiology, Liver Arjun Kalra; Ekrem Yetiskul; Chase J. Wehrle; Faiz Tuma.

19. IPSC-derived 3D human fatty liver models Maddalena Parafati, Siobhan Malany, in iPSCs in Tissue Engineering, 2021

Flisiak R. Role of Ito cells in the liver function. Pol J Pathol. 1997;48(3):139-45. Review. — View Citation

Hennedige T, Venkatesh SK. Imaging of hepatocellular carcinoma: diagnosis, staging and treatment monitoring. Cancer Imaging. 2013 Feb 8;12:530-47. doi: 10.1102/1470-7330.2012.0044. Review. — View Citation

Kaestner KH. Progress in molecular biology and translational science. development, differentiation and disease of the para-alimentary tract. Preface. Prog Mol Biol Transl Sci. 2010;97:xi-xii. doi: 10.1016/B978-0-12-385233-5.00015-5. — View Citation

Naran K, Nundalall T, Chetty S, Barth S. Principles of Immunotherapy: Implications for Treatment Strategies in Cancer and Infectious Diseases. Front Microbiol. 2018 Dec 21;9:3158. doi: 10.3389/fmicb.2018.03158. eCollection 2018. Review. — View Citation

Raza A, Sood GK. Hepatocellular carcinoma review: current treatment, and evidence-based medicine. World J Gastroenterol. 2014 Apr 21;20(15):4115-27. doi: 10.3748/wjg.v20.i15.4115. Review. — View Citation

Roth A, Schaffner W, Hertel C. Phytoestrogen kaempferol (3,4',5,7-tetrahydroxyflavone) protects PC12 and T47D cells from beta-amyloid-induced toxicity. J Neurosci Res. 1999 Aug 1;57(3):399-404. — View Citation

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)	HBV, HCV,... injure healthy liver cells, causing cell death and inflammation. Healthy liver tissue is replaced with scar tissue and the liver is damaged.	36 months
Secondary	The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)	Hepatocellular carcinoma occurs most often in people with chronic liver diseases, cirrhosis, such as cirrhosis caused by hepatitis B, hepatitis C infection,...	36 months

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