NCT01007656

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.

Trial Health

87
On Track

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Enrollment
31

participants targeted

Target at P25-P50 for not_applicable healthy

Timeline
Completed

Started Nov 2009

Shorter than P25 for not_applicable healthy

Geographic Reach
1 country

1 active site

Status
completed

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

First Submitted

Initial submission to the registry

October 30, 2009

Completed
2 days until next milestone

Study Start

First participant enrolled

November 1, 2009

Completed
3 days until next milestone

First Posted

Study publicly available on registry

November 4, 2009

Completed
2 months until next milestone

Primary Completion

Last participant's last visit for primary outcome

January 1, 2010

Completed
2 months until next milestone

Study Completion

Last participant's last visit for all outcomes

March 1, 2010

Completed
3.8 years until next milestone

Results Posted

Study results publicly available

December 2, 2013

Completed
Last Updated

June 21, 2016

Status Verified

May 1, 2016

Enrollment Period

2 months

First QC Date

October 30, 2009

Results QC Date

May 26, 2013

Last Update Submit

May 17, 2016

Conditions

Healthy

Keywords

healthy adult subjectssafety evaluationGD Antrodia camphorata

Outcome Measures

Primary Outcomes (15)

  • Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)

    90 days

  • Serum Glutamic Pyruvate Transaminase (ALT/SGPT)

    90 days

  • Triglycerides (TG)

    90 days

  • Total Protein

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

    90 days

  • Uric Acid

    90 days

  • Albumin

    90 days

  • Alkaline Phosphatase

    90 days

  • Direct Bilirubin

    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.

    90 days

  • Total Bilirubin

    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.

    90 days

  • BUN

    90 days

  • Cholesterol

    90 days

  • Creatinine

    90 days

  • Globulin

    90 days

  • Glucose

    90 days

  • R-glutamyl Transpeptidase (r-GT)

    90 days

Study Arms (1)

GD Antrodia camphorata

EXPERIMENTAL

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

Interventions

GD Antrodia camphorataDIETARY_SUPPLEMENT

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

GD Antrodia camphorata

Eligibility Criteria

Age20 Years - 40 Years
Sexall
Healthy VolunteersYes
Age GroupsAdult (18-64)

You may qualify if:

  • 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

You may not qualify if:

  • 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.

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (1)

PingTung Christian Hospital

Pingtung City, Taiwan

Location

Related Publications (1)

  • 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.

    PMID: 12744658BACKGROUND

Results Point of Contact

Title
Dr. Choo-Aun Neoh
Organization
PingTung Christian Hospital Ruiguang Branch
neohca@gmail.com
886-8-736-8686

Study Officials

  • Choo-Aun Neoh

    PingTung Christian Hospital

    PRINCIPAL INVESTIGATOR

Publication Agreements

PI is Sponsor Employee
No
Restrictive Agreement
No

Study Design

Study Type
interventional
Phase
not applicable
Allocation
NA
Masking
NONE
Intervention Model
SINGLE GROUP
Sponsor Type
INDUSTRY
Responsible Party
SPONSOR

Study Record Dates

First Submitted

October 30, 2009

First Posted

November 4, 2009

Study Start

November 1, 2009

Primary Completion

January 1, 2010

Study Completion

March 1, 2010

Last Updated

June 21, 2016

Results First Posted

December 2, 2013

Record last verified: 2016-05

Data Sharing

IPD Sharing
Will share

Locations

TW(1)