Clinical trial NCT01007656: A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects
Official title: A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects
Study type: INTERVENTIONAL
Overall status: COMPLETED
Phase: NA
Conditions: Healthy
Keywords: healthy adult subjects
safety evaluation
GD Antrodia camphorata
Lead sponsor: Golden Biotechnology Corporation
Sponsor class: INDUSTRY
First posted: 2009-11-04
Enrollment: 31
Sex: ALL
Minimum age (years): 20
Maximum age (years): 40
Standard ages: ADULT
Accepts healthy volunteers: yes
Allocation: NA
Intervention model: SINGLE_GROUP

Brief 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.

Eligibility criteria: 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.

Primary outcomes:
measure: Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
timeFrame: 90 days
measure: Serum Glutamic Pyruvate Transaminase (ALT/SGPT)
timeFrame: 90 days
measure: Triglycerides (TG)
timeFrame: 90 days
measure: Total Protein
timeFrame: 90 days
measure: Uric Acid
timeFrame: 90 days
measure: Albumin
timeFrame: 90 days
measure: Alkaline Phosphatase
timeFrame: 90 days
measure: Direct Bilirubin
timeFrame: 90 days
measure: Total Bilirubin
timeFrame: 90 days
measure: BUN
timeFrame: 90 days
measure: Cholesterol
timeFrame: 90 days
measure: Creatinine
timeFrame: 90 days
measure: Globulin
timeFrame: 90 days
measure: Glucose
timeFrame: 90 days
measure: R-glutamyl Transpeptidase (r-GT)
timeFrame: 90 days
Secondary outcomes:
Other outcomes:
Locations:
city: Pingtung
country: Taiwan
facility: PingTung Christian Hospital
Study officials:
affiliation: PingTung Christian Hospital
name: Choo-Aun Neoh
role: PRINCIPAL_INVESTIGATOR
References:
citation: Hsiao G, Shen MY, Lin KH, Lan MH, Wu LY, Chou DS, Lin CH, Su CH, Sheu JR. Antioxidative and hepatoprotective effects of Antrodia camphorata extract. J Agric Food Chem. 2003 May 21;51(11):3302-8. doi: 10.1021/jf021159t.