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Completed

NCT Number: NCT01007656

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

* 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.

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Key information

Conditions

Healthy

Age range

20 year–40 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

PingTung Christian Hospital

Pingtung City, Taiwan

About this study

  • 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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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.

Treatment and study plan

GD Antrodia camphorata

Dietary Supplement

Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days

Primary outcomes

  1. Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)

    Time frame: 90 days

  2. Serum Glutamic Pyruvate Transaminase (ALT/SGPT)

    Time frame: 90 days

  3. Triglycerides (TG)

    Time frame: 90 days

  4. Total Protein

    Time frame: 90 days

    The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.

  5. Uric Acid

    Time frame: 90 days

  6. Albumin

    Time frame: 90 days

  7. Alkaline Phosphatase

    Time frame: 90 days

  8. Direct Bilirubin

    Time frame: 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.

  9. Total Bilirubin

    Time frame: 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.

  10. BUN

    Time frame: 90 days

  11. Cholesterol

    Time frame: 90 days

  12. Creatinine

    Time frame: 90 days

  13. Globulin

    Time frame: 90 days

  14. Glucose

    Time frame: 90 days

  15. R-glutamyl Transpeptidase (r-GT)

    Time frame: 90 days

Sponsors and collaborators

Lead sponsor

Golden Biotechnology Corporation

Industry

Registry information

Important dates

Study start
2009
Primary completion
2010
Study completion
2010
First posted
Nov 4, 2009
Registry last updated
Jun 21, 2016

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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