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)

PHASE II / III CLINICAL TRIAL

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

Trial Duration: 9 months treatment + 6 months follow-up

Trial Size: 280 patients

Trial Approval Granted:
April, 2003 (by Department of Health of Taiwan, ROC)

The latest fatty liver research report in 2008

In 2008, according to a report in the world's authoritative liver medicine journal (Hepatology: February 2008 issue), Korean pearl grass was tested on fatty liver in cell lines and animals. The test found that Korean pearl grass helps regulate the incomplete methionine- and -choline-deficient (MCD) media conversion process, inhibits liver fat accumulation, reduces the occurrence of sebaceous gland disease, improves liver inflammation, and helps alanine aminotransferase (ALT/GPT) return to normal.

In addition, the Royal Hospital of Wales has launched a new round of human clinical trials in May 2010, which brought hope to patients with fatty liver.

Using mouse model to explore the effect of Korean pearl grass on alcohol metabolism rate

Feeding mice "Korean Pearl Grass" two hours before intraperitoneal injection of alcohol can effectively accelerate the alcohol metabolism rate in the mice's blood, increase the alcohol detoxification function by 3.5 times, reduce drunkenness and hangover, and avoid damage to liver cells.