N/A N=31

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

Healthy

Bottom Line

View on ClinicalTrials.gov: NCT01007656 ↗

Enrolled (actual)

Serious AEs

0.0%

Results posted

Dec 2013

Primary outcome: Primary: Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) — 21.48 U/L

Study Design & Population

Study type: Interventional
Phase: N/A
Interventions: GD Antrodia camphorata (Dietary_supplement)
Age: Adult · 20+ yrs
Sex: All
Sponsor: Golden Biotechnology Corporation
Primary completion: Jan 2010

Outcome Measures

Outcome	Result	p-value
PRIMARY Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)	21.48	—
PRIMARY Serum Glutamic Pyruvate Transaminase (ALT/SGPT)	21.94	—
PRIMARY Triglycerides (TG)	56.39	—
PRIMARY Total Protein	7.25	—
PRIMARY Uric Acid	5.47	—
PRIMARY Albumin	4.74	—
PRIMARY Alkaline Phosphatase	55.81	—
PRIMARY Direct Bilirubin	0.10	—
PRIMARY Total Bilirubin	0.73	—
PRIMARY BUN	9.32	—
PRIMARY Cholesterol	173.13	—
PRIMARY Creatinine	0.84	—
PRIMARY Globulin	2.51	—
PRIMARY Glucose	80.13	—
PRIMARY R-glutamyl Transpeptidase (r-GT)	17.42	—

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.

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.

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Data sourced from ClinicalTrials.gov (NCT01007656). Outcome figures and adverse-event rates are extracted automatically from the registry's posted results and are provided for clinician reference, not as a substitute for the primary publication.