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

Composition for Treating Cirrhosis and Liver Cancer

Status
Completed
Phases
Phase 4
Study type
Interventional
Source
ClinicalTrials.gov
Registry ID
NCT05178303
Acronym
SB-1121
Enrollment
134
Registered
2022-01-05
Start date
2015-11-30
Completion date
2021-11-10
Last updated
2025-05-16

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Cirrhosis of the Liver

Keywords

Liver, Cirrhosis, Hcc, Flavonoids, Pregnenolone, Ascorbic acid, B6

Brief 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.

Interventions

DRUGSB-1121(1)

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

DRUGSB-1121(2)

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

Sponsors

Tran Minh Duc
CollaboratorUNKNOWN
Nguyen Thi Trieu, MD
Lead SponsorINDIV

Study design

Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
SINGLE (Subject)

Eligibility

Sex/Gender
ALL
Age
18 Years to 80 Years
Healthy volunteers
Yes

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.

Design outcomes

Primary

MeasureTime frameDescription
The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)36 monthsHBV, HCV,... injure healthy liver cells, causing cell death and inflammation. Healthy liver tissue is replaced with scar tissue and the liver is damaged.

Secondary

MeasureTime frameDescription
The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)36 monthsHepatocellular carcinoma occurs most often in people with chronic liver diseases, cirrhosis, such as cirrhosis caused by hepatitis B, hepatitis C infection,...

Countries

United States, Vietnam

Outcome results

None listed

Source: ClinicalTrials.gov · Data processed: Feb 4, 2026