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

This study has been completed.
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation
ClinicalTrials.gov Identifier:
NCT01007656
First received: October 30, 2009
Last updated: October 1, 2013
Last verified: October 2013
  Purpose
  • 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.

Condition Intervention
Healthy
Dietary Supplement: GD Antrodia camphorata

Study Type: Interventional
Study Design: Endpoint Classification: Safety Study
Intervention Model: Single Group Assignment
Masking: Open Label
Official Title: A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects

Resource links provided by NLM:


Further study details as provided by Golden Biotechnology Corporation:

Primary Outcome Measures:
  • Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Serum Glutamic Pyruvate Transaminase (ALT/SGPT) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Triglycerides (TG) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Total Protein [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.

  • Uric Acid [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Albumin [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Alkaline Phosphatase [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Direct Bilirubin [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
    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 [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Cholesterol [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Creatinine [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Globulin [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • Glucose [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]
  • R-glutamyl Transpeptidase (r-GT) [ Time Frame: 90 days ] [ Designated as safety issue: Yes ]

Enrollment: 31
Study Start Date: November 2009
Study Completion Date: March 2010
Primary Completion Date: January 2010 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: 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).
Dietary Supplement: GD Antrodia camphorata
Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days

  Eligibility

Ages Eligible for Study:   20 Years to 40 Years
Genders Eligible for Study:   Both
Accepts Healthy Volunteers:   Yes
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.
  Contacts and Locations
Please refer to this study by its ClinicalTrials.gov identifier: NCT01007656

Locations
Taiwan
PingTung Christian Hospital
Pingtung, Taiwan
Sponsors and Collaborators
Golden Biotechnology Corporation
Investigators
Principal Investigator: Choo-Aun Neoh PingTung Christian Hospital
  More Information

Publications:
Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT01007656     History of Changes
Other Study ID Numbers: IRC01080923
Study First Received: October 30, 2009
Results First Received: May 26, 2013
Last Updated: October 1, 2013
Health Authority: Taiwan: Department of Health

Keywords provided by Golden Biotechnology Corporation:
healthy adult subjects
safety evaluation
GD Antrodia camphorata

ClinicalTrials.gov processed this record on April 16, 2014