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

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
ClinicalTrials.gov Identifier: NCT01007656
Recruitment Status : Completed
First Posted : November 4, 2009
Results First Posted : December 2, 2013
Last Update Posted : June 21, 2016
Sponsor:
Information provided by (Responsible Party):
Golden Biotechnology Corporation

Study Type Interventional
Study Design Intervention Model: Single Group Assignment;   Masking: None (Open Label)
Condition Healthy
Intervention Dietary Supplement: GD Antrodia camphorata
Enrollment 31
Recruitment Details Thirty-one (31) healthy adult subjects enrolled the study. The study period was a continuous 90-day. Each subject received GD Antrodia Camphorata (as three 500 mg capsules) at 7:30 and 19:30 for continuous 90- day.
Pre-assignment Details One participant didn't continue on the trial by his own will.
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description 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).
Period Title: Overall Study
Started 31
Completed 31
Not Completed 0
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description 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).
Overall Number of Baseline Participants 31
Hide Baseline Analysis Population Description
Laboratory measurements, including serum glutamic oxaloacetate transaminase (SGOT), serum glutamic pyruvate transaminase (SGPT), albumin, glucose, creatinine, uric acid, cholesterol, Triglycerides (TG), r-glutamyl transpeptidase(r-GT), alkaline phosphatase, total bilirubin, Direct- bilirubin (D-Bil), BUN, Total protein (TP), Globulin (GLO).
Age, Categorical  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
<=18 years
0
   0.0%
Between 18 and 65 years
31
 100.0%
>=65 years
0
   0.0%
Sex: Female, Male  
Measure Type: Count of Participants
Unit of measure:  Participants
Number Analyzed 31 participants
Female
11
  35.5%
Male
20
  64.5%
Region of Enrollment  
Measure Type: Number
Unit of measure:  Participants
Taiwan Number Analyzed 31 participants
31
Serum glutamic oxaloacetic transaminase SGOT (AST)   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 31 participants
16.74  (3.95)
[1]
Measure Description: Blood was sampled from an antecubital vein of the forearm for the laboratory measurement at 07:30 in the morning. Qualified medical personnel will attend the whole study. No smoking, alcohol and caffeine consumption will be permitted for at least 48 hours before and during the study.
Serum glutamic pyruvate transaminase, SGPT (ALT)   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 31 participants
17.32  (9.03)
[1]
Measure Description: Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Triglycerides (TG)   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
75.19  (35.16)
[1]
Measure Description: Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning. Qualified medical personnel will attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Total protein   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 31 participants
6.88  (0.32)
[1]
Measure Description: The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 am. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Uric acid   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
5.79  (1.13)
[1]
Measure Description: Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning.
Albumin   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 31 participants
4.47  (0.16)
[1]
Measure Description: Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Alkaline phosphatase   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 31 participants
52.06  (13.18)
[1]
Measure Description: Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Direct bilirubin   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
0.16  (0.06)
[1]
Measure Description: Bilirubin is brownish yellow substance found in bile. It's produced when the liver breaks down old red blood cells. Bilirubin circulates in the bloodstream in two forms: indirect and direct bilirubin. Direct bilirubin is made by the liver from indirect form. This test can be used to check the liver function. Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement.
Total bilirubin   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
0.80  (0.28)
[1]
Measure Description: Total bilirubin is referred to the sum of direct bilirubin and indirect bilirubin. Direct bilirubin is water- soluble form, made by the liver. Indirect bilirubin is not soluble in water due to the intramolecular hydrogen bond. Indirect bilirubin circulates in plasma. Total bilirubin test can be used to check liver function and haemolytic disease. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
BUN   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
10.70  (2.53)
[1]
Measure Description: Subjects fasted for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 am. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Cholesterol   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
169.10  (27.05)
[1]
Measure Description: Subjects fasted for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Creatinine   [1] 
Mean (Standard Deviation)
Unit of measure:  mg/dL
Number Analyzed 31 participants
0.78  (0.15)
[1]
Measure Description: Subjects fasted for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 am. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
Globulin   [1] 
Mean (Standard Deviation)
Unit of measure:  g/dL
Number Analyzed 31 participants
2.41  (0.32)
[1]
Measure Description: Globulin proteins include enzymes, antibodies and more than 500 other proteins. Subjects fasted for 8 hours prior to study product administration at 7:30 am in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement at 7:30 in the morning. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
r-glutamyl transpeptidase (r-GT)   [1] 
Mean (Standard Deviation)
Unit of measure:  U/L
Number Analyzed 31 participants
14.90  (6.85)
[1]
Measure Description: Subjects would fast for 8 hours prior to study product administration at 7:30 in the morning. Blood would be sampled from an antecubital vein of the forearm for the laboratory measurement. Qualified medical personnel would attend the whole study. No smoking, alcohol and caffeine consumption would be permitted for at least 48 hours before and during the study.
1.Primary Outcome
Title Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: U/L
21.48  (6.43)
2.Primary Outcome
Title Serum Glutamic Pyruvate Transaminase (ALT/SGPT)
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: U/L
21.94  (10.10)
3.Primary Outcome
Title Triglycerides (TG)
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
56.39  (23.17)
4.Primary Outcome
Title Total Protein
Hide Description The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: g/dL
7.25  (0.34)
5.Primary Outcome
Title Uric Acid
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
5.47  (1.25)
6.Primary Outcome
Title Albumin
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: g/dL
4.74  (0.20)
7.Primary Outcome
Title Alkaline Phosphatase
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: U/L
55.81  (14.33)
8.Primary Outcome
Title Direct Bilirubin
Hide Description 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.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.10  (0.07)
9.Primary Outcome
Title Total Bilirubin
Hide Description 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.
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.73  (0.32)
10.Primary Outcome
Title BUN
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
9.32  (2.49)
11.Primary Outcome
Title Cholesterol
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
173.13  (28.09)
12.Primary Outcome
Title Creatinine
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
0.84  (0.16)
13.Primary Outcome
Title Globulin
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: g/dL
2.51  (0.29)
14.Primary Outcome
Title Glucose
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: mg/dL
80.13  (6.13)
15.Primary Outcome
Title R-glutamyl Transpeptidase (r-GT)
Hide Description [Not Specified]
Time Frame 90 days
Hide Outcome Measure Data
Hide Analysis Population Description
[Not Specified]
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description:
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).
Overall Number of Participants Analyzed 31
Mean (Standard Deviation)
Unit of Measure: U/L
17.42  (7.76)
Time Frame [Not Specified]
Adverse Event Reporting Description [Not Specified]
 
Arm/Group Title GD Antrodia Camphorata
Hide Arm/Group Description 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).
All-Cause Mortality
GD Antrodia Camphorata
Affected / at Risk (%)
Total   --/-- 
Show Serious Adverse Events Hide Serious Adverse Events
GD Antrodia Camphorata
Affected / at Risk (%)
Total   0/31 (0.00%) 
Show Other (Not Including Serious) Adverse Events Hide Other (Not Including Serious) Adverse Events
Frequency Threshold for Reporting Other Adverse Events 0%
GD Antrodia Camphorata
Affected / at Risk (%)
Total   0/31 (0.00%) 
Certain Agreements
Principal Investigators are NOT employed by the organization sponsoring the study.
There is NOT an agreement between Principal Investigators and the Sponsor (or its agents) that restricts the PI's rights to discuss or publish trial results after the trial is completed.
Results Point of Contact
Name/Title: Dr. Choo-Aun Neoh
Organization: PingTung Christian Hospital Ruiguang Branch
Phone: 886-8-736-8686 ext 5310
Responsible Party: Golden Biotechnology Corporation
ClinicalTrials.gov Identifier: NCT01007656     History of Changes
Other Study ID Numbers: IRC01080923
First Submitted: October 30, 2009
First Posted: November 4, 2009
Results First Submitted: May 26, 2013
Results First Posted: December 2, 2013
Last Update Posted: June 21, 2016