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

December 15, 2021 updated by: Nguyen Thi Trieu, MD

Composition for Treating Cirrhosis and Liver Cancer

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.

Study Overview

Status

Completed

Conditions

Intervention / Treatment

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 Type

Interventional

Enrollment (Actual)

134

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Vietnam
      • Ho Chi Minh City, Vietnam, 700000
        • Saigon Biopharma Company Limited

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 80 years (ADULT, OLDER_ADULT)

Accepts Healthy Volunteers

Yes

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: TREATMENT
  • Allocation: RANDOMIZED
  • Interventional Model: PARALLEL
  • Masking: SINGLE

Arms and Interventions

Participant Group / 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

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)
Time Frame: 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.
36 months

Secondary Outcome Measures

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

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Nguyen Thi Trieu, MD

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Helpful Links

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (ACTUAL)

November 30, 2015

Primary Completion (ACTUAL)

October 10, 2021

Study Completion (ACTUAL)

November 10, 2021

Study Registration Dates

First Submitted

December 1, 2021

First Submitted That Met QC Criteria

December 15, 2021

First Posted (ACTUAL)

January 5, 2022

Study Record Updates

Last Update Posted (ACTUAL)

January 5, 2022

Last Update Submitted That Met QC Criteria

December 15, 2021

Last Verified

December 1, 2021

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • Cirrhosis and Hcc

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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