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

Study Overview
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Brief Summary
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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
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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.

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

Conditions
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Healthy

Intervention / Treatment
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* Dietary Supplement: GD Antrodia camphorata


Participation Criteria
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Eligibility Criteria
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Inclusion Criteria: Healthy adult, aged between 20 to 40 years old Physically and mentally healthy subjects as confirmed by an interview, medical history, clinical examination, laboratory tests, chest X-ray and electrocardiogram The normal range of the body mass index should between 18.5 and 24.9; body mass equals [weight(Kg)]/[height(m)]2 Normal laboratory determinations results (within normal range or considered not clinically significant by the investigator) including: SGOT (AST), SGPT (ALT), albumin, glucose, creatinine, uric acid, cholesterol, TG, γ-GT, alkaline phosphatase, total bilirubin, D-Bil, BUN, TP, GLO, HBsAg and Anti-HCV. Normal hematology results (within normal range or considered not clinically significant by the investigator) including: hemoglobin, hematocrit, WBC count with differential, RBC count and platelet count. Normal urinalysis results (within normal range or considered not clinically significant by the investigator) including: glucose, protein, RBC, WBC, epith, casts and bacteria. Female subject who is using adequate contraception since last menstruation and no plan for conception during the study Female subject who is non-lactating Female subject who has negative pregnancy test (urine) within 14 days prior to the study Informed consent form signed Exclusion Criteria: A recent history of drug or alcohol abuse Medical history of allergic asthma or sensitivity to analogous product A clinically significant illness within the past 4 weeks. Evidence of any clinical significant renal, cardiovascular, hepatic, hematopoetic, neurological, pulmonary or gastrointestinal pathology within the past 4 weeks. Ongoing peptic ulcer and constipation. Planed vaccination during the time course of the study. Participation of any clinical investigation during the last 60 days. Regular use of any medication during the last 4 weeks. Single use of any medication during the last one week. Blood donation of more than 500 mL within the past 12 weeks. Individuals are judged by the investigators or co-investigator to be undesirable as subjects.

Ages Eligible for Study
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Minimum Age: 20 Years
Maximum Age: 40 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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Accepts Healthy Volunteers

Study Plan
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How is the study designed?
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Design Details

Intervention Model: Single Group Assignment
Masking: None (Open Label)


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: GD Antrodia camphorata<br>GD Antrodia Camphorata is the extract from mycelium of the fungus Antrodia Camphorata which is an endemic species in Taiwan. According to the literatures, mycelium of Antrodia camphorata is beneficial to health. Moreover, the study product GD Antrodia Camphorata has been approved by Department of Health, Taiwan as a health supplement (approval number A00124). | Dietary Supplement: GD Antrodia camphorata<br>* Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) |  | 90 days | 
| Serum Glutamic Pyruvate Transaminase (ALT/SGPT) |  | 90 days | 
| Triglycerides (TG) |  | 90 days | 
| Total Protein | The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin. | 90 days | 
| Uric Acid |  | 90 days | 
| Albumin |  | 90 days | 
| Alkaline Phosphatase |  | 90 days | 
| Direct Bilirubin | Direct bilirubin is referred to as conjugated bilirubin, which is water-soluble. It's taken up by the liver cells and conjugated to form the water-soluble bilirubin diglucuronide. It's used to diagnose and/or monitor liver diseases, such as cirrhosis, hepatitis or gallstones. If direct bilirubin is elevated more than unconjugated bilirubin, there's typically a problem associated with decreased elimination of bilirubin by the liver cells. | 90 days | 
| Total Bilirubin | Bilirubin is released into the blood when red blood cells break down. The liver uses bilirubin to make bile. Normally there is only a small amount of bilirubin in the blood. High levels may be caused by liver or blood problems. | 90 days | 
| BUN |  | 90 days | 
| Cholesterol |  | 90 days | 
| Creatinine |  | 90 days | 
| Globulin |  | 90 days | 
| Glucose |  | 90 days | 
| R-glutamyl Transpeptidase (r-GT) |  | 90 days | 

 Terms related to the study
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Keywords Provided by Centre Hospitalier Valida
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healthy adult subjects, safety evaluation, GD Antrodia camphorata