NCT05178303

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

Composition for Treating Cirrhosis and Liver Cancer

• Status: Completed
• Phase: Phase 4
• Study type: Interventional
• Enrollment: 134 (actual)
• Sponsor: Nguyen Thi Trieu, MD · Individual
• Sex: All
• Age: 18 Years – 80 Years
• Healthy volunteers: Accepted

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.

Detailed 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.

Conditions

• Cirrhosis of the Liver

Interventions

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

Timeline

• Start date: 2015-11-30
• Primary completion: 2021-10-10
• Completion: 2021-11-10
• First posted: 2022-01-05
• Last updated: 2025-05-16

Locations

2 sites across 2 countries: United States, Vietnam

Regulatory

• FDA-regulated drug study