NCT01007656

A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 31 (actual)
• Sponsor: Golden Biotechnology Corporation · Industry
• Sex: All
• Age: 20 Years – 40 Years
• Healthy volunteers: Accepted

Summary

* Study design is multiple-dose, open-label study * The purpose of this study is to evaluate the safety after twice daily GD Antrodia camphorata administration for 90 days in 30 healthy adult subjects. * Primary objective: The mean change from baseline in laboratory assessment after twice daily GD Antrodia camphorata administration at 90th day in 30 healthy adult subjects. * Secondary objective: The mean change from baseline in laboratory assessment after twice daily GD Antrodia camphorata administration at 10th, 20th, 30th, 45th and 60th day in 30 healthy adult subjects. * Safety Measurement: * including SGOT(AST), SGPT(ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day. * vital signs (heart rate, blood pressure, and body temperature) will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day. * Subjects will be monitored throughout the confinement portion of the study.

Detailed description

* Study design is multiple-dose, open-label study * Antrodia camphorata has been proved to alleviate liver injury and fibrosis induced by chemical and reduces ALT and AST according to the literatures. * "GD Antrodia camphorata" will be marketed as dietary supplement. * The purpose of this study is to evaluate the safety after twice daily GD Antrodia camphorata administration for 90 days in 30 healthy adult subjects. * Primary objective: The mean change from baseline in laboratory assessment after twice daily GD Antrodia camphorata administration at 90th day in 30 healthy adult subjects. * Secondary objective: The mean change from baseline in laboratory assessment after twice daily GD Antrodia camphorata administration at 10th, 20th, 30th, 45th and 60th day in 30 healthy adult subjects. * Study design is multiple-dose, open-label study * The study site is Pingtung Christian Hospital Ruiguang Branch. * Safety Measurement: * including SGOT(AST), SGPT(ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, r-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day. * vital signs (heart rate, blood pressure, and body temperature) will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day. * Subjects will be monitored throughout the confinement portion of the study.

Conditions

• Healthy

Interventions

Type	Name	Description
DIETARY_SUPPLEMENT	GD Antrodia camphorata	Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days

Timeline

• Start date: 2009-11-01
• Primary completion: 2010-01-01
• Completion: 2010-03-01
• First posted: 2009-11-04
• Last updated: 2016-06-21
• Results posted: 2013-12-02

Locations

1 site across 1 country: Taiwan