Clinical trial NCT05178303: Composition for Treating Cirrhosis and Liver Cancer (SB-1121)
Official title: Composition for Treating Cirrhosis and Liver Cancer
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: PHASE4
Conditions: Cirrhosis of the Liver
Keywords: Liver
Cirrhosis
Hcc
Flavonoids
Pregnenolone
Ascorbic acid
B6
Lead sponsor: Trieu, Nguyen Thi, M.D.
Sponsor class: INDIV
Collaborators: name: Tran Minh Duc
First posted: 2022-01-05
Enrollment: 134
Sex: ALL
Minimum age (years): 18
Maximum age (years): 80
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: yes
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

Eligibility criteria: 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.

Primary outcomes:
measure: The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)
timeFrame: 36 months
Secondary outcomes:
measure: The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)
timeFrame: 36 months
Other outcomes:
Locations:
city: Wilmington
country: United States
facility: Saigon Biopharma LLC
state: Delaware
city: Ho Chi Minh City
country: Vietnam
facility: Saigon Biopharma Company Limited
Study officials:
affiliation: Saigon Biopharma Company Limited
name: Tran Minh Cam Tu, Dr.
role: PRINCIPAL_INVESTIGATOR
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