Research History | PU Koreana | Clinical Studies | GMP

Clinical Studies

PHARMACOLOGY

TOXICOLOGY

Genotoxicology Studies

    Salmonella / Microsome Mutation Assay (AMES Test)

    Mouse Peripheral Blood Micronucleus Assay

    In Vitro Chromosome Aberration Assay in Human Peripheral Lymphocytes

Toxicology Studies

    Acute oral toxicity test of Phyllanthus extract on mice

    Acute toxicity test on mice by intraperitoneal administration for Phyllanthus

    Acute oral toxicity test on beagle dog for Phyllanthus extract

    Chronic toxicology and pharmacology of aqueous extracts of Phyllanthus urinaria in woodchucks

    The 4 week repeated dose toxicity study (oral) in rats – Phyllanthus Urinaria Extracts

PHASE II CLINICAL TRIAL

Randomized, Controlled, Phase II Clinical Trials of Hepaguard^®
for the evaluation of Efficacy and Safety with Chronic Hepatitis B Patients

Trial Duration: 12 months

Trial Size: 30

During the course of treatment:

28 patients: HBV-DNA (+) > HBV-DNA (-)

7 patients: HBeAg (+) > HBeAg (-) &

Anti-HBeAb (-) > Anti-HBeAb (+)

PHASE III CLINICAL TRIAL

Randomized, Multicenter, Double-blind, Double-dummy, Placebo-controlled Study of Hepaguard^® in Patients with Chronic Hepatitis B Infection

Trial Duration:
9 months + 1 month follow-up

Trial Size:
Treatment Group - 80 patients
Comparative Group - 40 patients

Trial Completion:
May, 2002

OTC Drug License Granted:
April, 2003 (by Korea FDA)

Alcohol Metabolism Study for Phyllanthus Urinaria Koreana in Mice

           Animal Technology Institute Taiwan

2 hours prior and long term consumption of Phyllanthus Urinaria Korean promote and increase alcohol metabolism.