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

May 17, 2016 updated by: Golden Biotechnology Corporation
  • 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.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Completed

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

  • 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.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Actual)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
31

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • Taiwan
      • Pingtung, Taiwan
        • Pingtung Christian Hospital

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

20 years to 40 years (Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Allocation: N/A
  • Interventional Model: Single Group Assignment
  • Masking: None (Open Label)

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
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

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
Time Frame: 90 days
90 days
Serum Glutamic Pyruvate Transaminase (ALT/SGPT)
Time Frame: 90 days
90 days
Triglycerides (TG)
Time Frame: 90 days
90 days
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.
90 days
Uric Acid
Time Frame: 90 days
90 days
Albumin
Time Frame: 90 days
90 days
Alkaline Phosphatase
Time Frame: 90 days
90 days
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.
90 days
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.
90 days
BUN
Time Frame: 90 days
90 days
Cholesterol
Time Frame: 90 days
90 days
Creatinine
Time Frame: 90 days
90 days
Globulin
Time Frame: 90 days
90 days
Glucose
Time Frame: 90 days
90 days
R-glutamyl Transpeptidase (r-GT)
Time Frame: 90 days
90 days

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Golden Biotechnology Corporation

Investigators

Investigators

A researcher involved in a clinical study. Related terms include site principal investigator, site sub-investigator, study chair, study director, and study principal investigator.
  • Principal Investigator: Choo-Aun Neoh, Pingtung Christian Hospital

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
November 1, 2009

Primary Completion (Actual)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
January 1, 2010

Study Completion (Actual)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
March 1, 2010

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
October 30, 2009

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
November 3, 2009

First Posted (Estimate)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
November 4, 2009

Study Record Updates

Last Update Posted (Estimate)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
June 21, 2016

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
May 17, 2016

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
May 1, 2016

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • IRC01080923

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

Yes

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Healthy

Clinical Trials on GD Antrodia camphorata

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Cookie Settings

We use cookies to ensure that we give you the best experience on our website. For more details carefully read our Privacy and Cookies Policy. ...>>>You can change your preferences or withdraw your consent at any time by deleting the cookies from your website or computer as described in the policy. Please accept it and choose your preferences by ticking the corresponding boxes in the "Manage Settings" section below. Please carefully read our Terms of Service before you proceed with using any part of this website.
«Manage Settings