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

Primary Purpose

Cirrhosis of the Liver

Status
Completed
Phase
Not Applicable
Locations
Vietnam
Study Type
Interventional
Intervention
SB-1121(1)
SB-1121(2)
Sponsored by
Nguyen Thi Trieu, MD
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Cirrhosis of the Liver focused on measuring Liver, Cirrhosis, Hcc, Flavonoids, Pregnenolone, Ascorbic acid, B6

Eligibility Criteria

18 Years - 80 Years (Adult, Older Adult)All SexesAccepts Healthy Volunteers

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.

Sites / Locations

  • Saigon Biopharma Company Limited

Arms of the Study

Arm 1

Arm 2

Arm Type

Experimental

Experimental

Arm Label

Cirrhosis

Cirrhosis/Hcc "stable"

Arm Description

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.

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.

Outcomes

Primary Outcome Measures

The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)
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)
Hepatocellular carcinoma occurs most often in people with chronic liver diseases, cirrhosis, such as cirrhosis caused by hepatitis B, hepatitis C infection,...

Full Information

First Posted
December 1, 2021
Last Updated
December 15, 2021
Sponsor
Nguyen Thi Trieu, MD
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1. Study Identification

Unique Protocol Identification Number
NCT05178303
Brief Title
Composition for Treating Cirrhosis and Liver Cancer (SB-1121)
Acronym
SB-1121
Official Title
Composition for Treating Cirrhosis and Liver Cancer
Study Type
Interventional

2. Study Status

Record Verification Date
December 2021
Overall Recruitment Status
Completed
Study Start Date
November 30, 2015 (Actual)
Primary Completion Date
October 10, 2021 (Actual)
Study Completion Date
November 10, 2021 (Actual)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor-Investigator
Name of the Sponsor
Nguyen Thi Trieu, MD

4. Oversight

Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No

5. 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Cirrhosis of the Liver
Keywords
Liver, Cirrhosis, Hcc, Flavonoids, Pregnenolone, Ascorbic acid, B6

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
Participant
Allocation
Randomized
Enrollment
134 (Actual)

8. Arms, Groups, and Interventions

Arm Title
Cirrhosis
Arm Type
Experimental
Arm Description
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.
Arm Title
Cirrhosis/Hcc "stable"
Arm Type
Experimental
Arm Description
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.
Intervention Type
Drug
Intervention Name(s)
SB-1121(1)
Other Intervention Name(s)
Cirrhosis/SB-1121
Intervention Description
The daily maintenance, SB-1121(1) dose is to take 2 times a day, 1 tablet each time.
Intervention Type
Drug
Intervention Name(s)
SB-1121(2)
Other Intervention Name(s)
Cirrhosis/Hcc/SB-1121
Intervention Description
The daily maintenance, SB-1121(2) dose is to take 2 times a day, 1 tablet each time.
Primary Outcome Measure Information:
Title
The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis (Arm 1)
Description
HBV, HCV,... injure healthy liver cells, causing cell death and inflammation. Healthy liver tissue is replaced with scar tissue and the liver is damaged.
Time Frame
36 months
Secondary Outcome Measure Information:
Title
The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)
Description
Hepatocellular carcinoma occurs most often in people with chronic liver diseases, cirrhosis, such as cirrhosis caused by hepatitis B, hepatitis C infection,...
Time Frame
36 months

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
80 Years
Accepts Healthy Volunteers
Accepts Healthy Volunteers
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.
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Tran Minh Cam Tu, Dr.
Organizational Affiliation
Saigon Biopharma Company Limited
Official's Role
Principal Investigator
Facility Information:
Facility Name
Saigon Biopharma Company Limited
City
Ho Chi Minh City
ZIP/Postal Code
700000
Country
Vietnam

12. IPD Sharing Statement

Plan to Share IPD
No
Citations:
PubMed Identifier
24764650
Citation
Raza A, Sood GK. Hepatocellular carcinoma review: current treatment, and evidence-based medicine. World J Gastroenterol. 2014 Apr 21;20(15):4115-27. doi: 10.3748/wjg.v20.i15.4115.
Results Reference
result
PubMed Identifier
30571059
Citation
Kalra A, Yetiskul E, Wehrle CJ, Tuma F. Physiology, Liver. 2023 May 1. In: StatPearls [Internet]. Treasure Island (FL): StatPearls Publishing; 2023 Jan-. Available from http://www.ncbi.nlm.nih.gov/books/NBK535438/
Results Reference
result
PubMed Identifier
30622524
Citation
Naran K, Nundalall T, Chetty S, Barth S. Principles of Immunotherapy: Implications for Treatment Strategies in Cancer and Infectious Diseases. Front Microbiol. 2018 Dec 21;9:3158. doi: 10.3389/fmicb.2018.03158. eCollection 2018.
Results Reference
result
PubMed Identifier
10412031
Citation
Roth A, Schaffner W, Hertel C. Phytoestrogen kaempferol (3,4',5,7-tetrahydroxyflavone) protects PC12 and T47D cells from beta-amyloid-induced toxicity. J Neurosci Res. 1999 Aug 1;57(3):399-404.
Results Reference
result
PubMed Identifier
9401406
Citation
Flisiak R. Role of Ito cells in the liver function. Pol J Pathol. 1997;48(3):139-45.
Results Reference
result
PubMed Identifier
21074727
Citation
Kaestner KH. Progress in molecular biology and translational science. development, differentiation and disease of the para-alimentary tract. Preface. Prog Mol Biol Transl Sci. 2010;97:xi-xii. doi: 10.1016/B978-0-12-385233-5.00015-5. No abstract available.
Results Reference
result
Citation
19. IPSC-derived 3D human fatty liver models Maddalena Parafati, Siobhan Malany, in iPSCs in Tissue Engineering, 2021
Results Reference
result
PubMed Identifier
23400006
Citation
Hennedige T, Venkatesh SK. Imaging of hepatocellular carcinoma: diagnosis, staging and treatment monitoring. Cancer Imaging. 2013 Feb 8;12(3):530-47. doi: 10.1102/1470-7330.2012.0044.
Results Reference
result
Links:
URL
http://www.cancer.org/cancer/liver-cancer/causes-risks-prevention/risk-factors.html
Description
Liver Cancer Risk Factors
URL
http://www.hepatitis.va.gov/cirrhosis/background/stages.asp
Description
Viral Hepatitis and Liver Disease
URL
http://www.medicalnewstoday.com/articles/305075
Description
What does the liver do
URL
http://pubmed.ncbi.nlm.nih.gov/26286008/
Description
Flavonoids as Multi-target Inhibitors for Proteins Associated with Ebola Virus: In Silico Discovery Using Virtual Screening and Molecular Docking Studies
URL
http://www.ncbi.nlm.nih.gov/pmc/articles/PMC3659258/
Description
Vitamin C Is an Essential Factor on the Anti-viral Immune Responses through the Production of Interferon-α/β at the Initial Stage of Influenza A Virus (H3N2) Infection
URL
http://pubmed.ncbi.nlm.nih.gov/31852327/
Description
The antiviral properties of vitamin C

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

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