NCT01198860

Brief Summary

Phyllanthus Urinaria - Adenosma Glutinosum - Eclipta Prostrata - Ascorbic Acid combination plus Tenofovir in treatment of acute and chronic hepatitis B. Method the combination of drugs derived from natural and artificial medicaments. Has stronger effect on immune system, effective good against HBV replication. This is a substantial new insight into the pathogenesis of disease, with a clear path toward clinical application, or which would lead to a substantial advance and perfect in management or public health policy.

Trial Health

60
Monitor

Trial Health Score

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

Geographic Reach
2 countries

2 active sites

Status
unknown

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

Trial Relationships

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Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

September 4, 2010

Completed
6 days until next milestone

First Posted

Study publicly available on registry

September 10, 2010

Completed
Last Updated

December 15, 2025

Status Verified

December 1, 2025

First QC Date

September 4, 2010

Last Update Submit

December 7, 2025

Conditions

Keywords

HBsAg

Interventions

Drug: * Tenofovir * Phyllanthus Urinaria * Adenosma Glutinosum * Eclipta Prostrata * Ascorbic Acid

Also known as: - Ascorbic Acid, - Phyllanthus Urinaria, - Adenosma Glutinosum, - Eclipta Prostrata, - Tenofovir

Eligibility Criteria

Age18 Years - 60 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64)

You may qualify if:

  • Males and females ≥ 18 years of age with chronic and acute hepatitis B.
  • Hepatitis B surface antigen (HBsAg)(+) for a minimum of 6 months prior to entry.
  • Hepatitis B envelope antigen (HBeAg)(+) or (-) at baseline.
  • Patients having treated or untreated
  • Patients with compensated liver function (Child-Pugh score ≤ 6).
  • Informed writted consent.

You may not qualify if:

  • Any serious or active medical or psychiatric illness which, in the opinion of the investigator, would interfere with patient treatment, assessment or compliance with the protocol. or cytokine-based therapies with possible activity in hepatitis B disease within 6 months prior to study screening.
  • Organ or bone marrow transplant recipients.
  • Evidence of active liver disease to operate.
  • Received immunoglobulins, interferon or other immune e to other causes (e.g., Wilson's disease, hemochromatosis, autoimmune hepatitis, hepatitis C, hepatitis D or HIV.)
  • Patients taking parenteral (intravenous or intramuscular or subcutaneous) or oral steroids, immuno-suppressant therapies or chemotherapeutic agents within 2 months of study screening or expected to receive these agents during the course of the study.
  • Clinically relevant alcohol or drug use or history of alcohol or drug use considered by the investigator to be sufficient to hinder compliance with treatment, follow up procedures or evaluation of adverse events.
  • Hepatocellular carcinoma.
  • Serious concurrent medical illness other than hepatitis B.
  • History of hypersensitivity to nucleoside analogues.
  • Women of childbearing potential not practising adequate contraception.
  • Pregnancy or lactation.

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, Chronic

Interventions

Ascorbic AcidTenofovir

Condition Hierarchy (Ancestors)

Hepatitis BBlood-Borne InfectionsCommunicable DiseasesInfectionsHepadnaviridae InfectionsDNA Virus InfectionsVirus DiseasesHepatitis, Viral, HumanHepatitis, ChronicHepatitisLiver DiseasesDigestive System DiseasesChronic DiseaseDisease AttributesPathologic ProcessesPathological Conditions, Signs and Symptoms

Intervention Hierarchy (Ancestors)

Sugar AcidsAcids, AcyclicCarboxylic AcidsOrganic ChemicalsHydroxy AcidsCarbohydratesOrganophosphonatesOrganophosphorus CompoundsAdeninePurinesHeterocyclic Compounds, 2-RingHeterocyclic Compounds, Fused-RingHeterocyclic Compounds

Study Officials

  • Nguyễn Thị Triệu, Dr.

    Tran Minh Duc, Dr.

    STUDY DIRECTOR

Study Design

Study Type
expanded access
Sponsor Type
INDIV
Responsible Party
SPONSOR INVESTIGATOR
PI Title
Trần Minh Đức

Study Record Dates

First Submitted

September 4, 2010

First Posted

September 10, 2010

Last Updated

December 15, 2025

Record last verified: 2025-12

Locations