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

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.
    

Intervention name(s): GD Antrodia camphorata
Intervention type(s): Dietary Supplement
Intervention description(s): Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days
Intervention model: Single Group Assignment
Masking: None (Open Label)
Keywords: healthy adult subjects; safety evaluation; GD Antrodia camphorata