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

Sponsor

Nguyen Thi Trieu, MD (Other)

Overall Status

Completed

CT.gov ID

NCT05178303

Collaborator

(none)

134

Enrollment

Location

Arms

71.4

Actual Duration (Months)

1.9

Patients Per Site Per Month

Study Details

Study Description

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.

Condition or Disease	Intervention/Treatment	Phase
Cirrhosis of the Liver	Drug: SB-1121(1) Drug: SB-1121(2)	N/A

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.

Study Design

Study Type:

Interventional

Actual Enrollment :

134 participants

Allocation:

Randomized

Intervention Model:

Parallel Assignment

Masking:

Single (Participant)

Primary Purpose:

Treatment

Official Title:

Composition for Treating Cirrhosis and Liver Cancer

Actual Study Start Date :

Nov 30, 2015

Actual Primary Completion Date :

Oct 10, 2021

Actual Study Completion Date :

Nov 10, 2021

Arms and Interventions

Arm	Intervention/Treatment
Experimental: 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.	Drug: SB-1121(1) The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time. Other Names: Cirrhosis/SB-1121
Experimental: 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.	Drug: SB-1121(2) The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time. Other Names: Cirrhosis/Hcc/SB-1121

Arm

Intervention/Treatment

Experimental: 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.

Drug: SB-1121(1)

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

Other Names:

Cirrhosis/SB-1121

Experimental: 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.

Drug: SB-1121(2)

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

Other Names:

Cirrhosis/Hcc/SB-1121

Outcome Measures

Primary Outcome Measures

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

Secondary Outcome Measures

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

Eligibility Criteria

Criteria

Ages Eligible for Study:

18 Years to 80 Years

Sexes Eligible for Study:

All

Accepts 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.