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
- Triglycerides (TG)
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:
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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.
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.
研究组 & 干预措施
GD Antrodia camphorata
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).
干预措施: GD Antrodia camphorata (Dietary Supplement)
结局指标
主要结局
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 Pyruvate Transaminase (ALT/SGPT)
时间窗: 90 days
Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
时间窗: 90 days
Alkaline Phosphatase
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.
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.
BUN
时间窗: 90 days
Cholesterol
时间窗: 90 days
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