NCT07084948

Brief Summary

The composition treats Acute Hepatitis, Chronic Hepatitis, Cirrhosis, and hepatocellular carcinoma (S.B.Flavonoids) at an early stage. The product is ascorbic acid, L-Arginine hydrochloride, Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, and Rutin. These components have participated in protecting liver cell membranes, focusing on reducing liver stress and supporting their structure, repairing and regenerating new liver parenchyma, preventing fibrosis cell generation, and preventing liver cancer cell growth at an early stage. The composition supplements precursors that help the body strengthen antibodies and reduce the risk of inflammation, and restore the physiological and biochemical functions of liver cells after chronic inflammation.

Trial Health

90
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
134

participants targeted

Target at P50-P75 for phase_4

Timeline
Completed

Started Nov 2015

Longer than P75 for phase_4

Geographic Reach
2 countries

2 active sites

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

November 30, 2015

Completed
5.9 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

October 10, 2021

Completed
3.7 years until next milestone

Study Completion

Last participant's last visit for all outcomes

June 20, 2025

Completed
13 days until next milestone

First Submitted

Initial submission to the registry

July 3, 2025

Completed
22 days until next milestone

First Posted

Study publicly available on registry

July 25, 2025

Completed
Last Updated

September 11, 2025

Status Verified

September 1, 2025

Enrollment Period

5.9 years

First QC Date

July 3, 2025

Last Update Submit

September 4, 2025

Conditions

Keywords

Acid AscorbicL-Arginine hydrochlorideUrinariaflavone5,6-dihydroxy-7,8,4'-trimethoxy-flavoneQuercetinRutinKaempferol

Outcome Measures

Primary Outcomes (1)

  • Quantification of HBV-DNA, SGPT, SGOT. The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis

    HBV 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 Outcomes (1)

  • The test uses sound waves to measure the stiffness of liver tissue on patient cirrhosis/Hcc (Arm 2)

    36 months

Study Arms (2)

Tenofovir 300mg + SB Flavon

EXPERIMENTAL

Experimental benefits in resistance to the Hepatitis B Virus were observed in all patients who had previously received certain components of the treatment for acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma to Tenofovir + SB Flavon for various therapeutic purposes.

Drug: FlavonoidDrug: Tenofovir

Tenofovir 300mg

EXPERIMENTAL

Experimental benefits in resistance to the Hepatitis B Virus were observed in all patients who received the treatment with only Tenofovir for various therapeutic purposes.

Drug: Tenofovir

Interventions

The daily maintenance, Tenofovir 150mg + SB Flavon 1345mg dose is to be taken 2 times a day, 1 tablet each time. The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma at an early stage. The product is Acid ascorbic, L-Arginine hydrochloride, Kaempferol, Urinariaflavone, 5,6-dihydroxy-7,8,4'-trimethoxy-flavone, Quercetin, Rutin. Use these ingredients to protect liver cell membranes, preventing the growth of HBV in the body.

Also known as: Tenofovir + SB Flavon
Tenofovir 300mg + SB Flavon

The daily maintenance, Tenofovir 300mg dose is to be taken 1 time a day, 1 tablet each time. The composition treats acute hepatitis, chronic hepatitis, cirrhosis, and hepatocellular carcinoma.

Tenofovir 300mgTenofovir 300mg + SB Flavon

Eligibility Criteria

Age18 Years - 80 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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.

You may not qualify if:

  • Unstable cancer patients.
  • Decompensated cirrhosis.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (2)

Saigon Biopharma LLC

Wilmington, Delaware, 19801-6601, United States

Location

Saigon Biopharma Company Limited

Hồ Chí Minh, Ho Chi Minh City, 700000, Vietnam

Location

MeSH Terms

Conditions

Hepatitis B

Interventions

FlavonoidsTenofovir

Condition Hierarchy (Ancestors)

Blood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitisLiver DiseasesDigestive System Diseases

Intervention Hierarchy (Ancestors)

ChromonesBenzopyransPyransHeterocyclic Compounds, 1-RingHeterocyclic CompoundsHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingOrganophosphonatesOrganophosphorus CompoundsOrganic ChemicalsAdeninePurines

Study Design

Study Type
interventional
Phase
phase 4
Allocation
RANDOMIZED
Masking
SINGLE
Who Masked
PARTICIPANT
Purpose
SUPPORTIVE CARE
Intervention Model
PARALLEL
Sponsor Type
INDIV
Responsible Party
SPONSOR
Expanded Access
Yes

Study Record Dates

First Submitted

July 3, 2025

First Posted

July 25, 2025

Study Start

November 30, 2015

Primary Completion

October 10, 2021

Study Completion

June 20, 2025

Last Updated

September 11, 2025

Record last verified: 2025-09

Locations