N/A
Completed N=31
A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects
Healthy
Source: ClinicalTrials.gov NCT01007656 ↗
Enrolled (actual)
31
Serious AEs
0.0%
Results posted
Dec 2013
Primary outcomePrimary: Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) — 21.48 U/L
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.
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 | — |
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.
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. Informational only — not medical advice.