A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 31
- 试验地点
- 1
- 主要终点
- BUN
研究概览
简要总结
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Study design is multiple-dose, open-label study
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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.
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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.
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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.
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Safety Measurement:
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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.
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vital signs (heart rate, blood pressure, and body temperature) will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.
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Subjects will be monitored throughout the confinement portion of the study.
详细描述
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Study design is multiple-dose, open-label study
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Antrodia camphorata has been proved to alleviate liver injury and fibrosis induced by chemical and reduces ALT and AST according to the literatures.
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"GD Antrodia camphorata" will be marketed as dietary supplement.
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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.
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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.
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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.
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Study design is multiple-dose, open-label study
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The study site is Pingtung Christian Hospital Ruiguang Branch.
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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.
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vital signs (heart rate, blood pressure, and body temperature) will be documented at 1st, 10th, 20th, 30th, 45th, 60th and 90th day.
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Subjects will be monitored throughout the confinement portion of the study.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 盲法
- None
入排标准
- 年龄范围
- 20 Years 至 40 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •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
排除标准
- •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.
结局指标
主要结局
BUN
时间窗: 90 days
Cholesterol
时间窗: 90 days
Triglycerides (TG)
时间窗: 90 days
Total Protein
时间窗: 90 days
The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.
Uric Acid
时间窗: 90 days
Albumin
时间窗: 90 days
Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
时间窗: 90 days
Serum Glutamic Pyruvate Transaminase (ALT/SGPT)
时间窗: 90 days
Direct Bilirubin
时间窗: 90 days
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.
Alkaline Phosphatase
时间窗: 90 days
Total Bilirubin
时间窗: 90 days
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.
Creatinine
时间窗: 90 days
Globulin
时间窗: 90 days
Glucose
时间窗: 90 days
R-glutamyl Transpeptidase (r-GT)
时间窗: 90 days
次要结局
未报告次要终点