Trial Outcomes & Findings for A Multiple-Dose Research Study on Safety Evaluation of the GD Antrodia Camphorata in 30 Healthy Adult Subjects (NCT NCT01007656)

NCT ID: NCT01007656

Last Updated: 2016-06-21

Results Overview

• Recruitment status: COMPLETED
• Study phase: NA
• Target enrollment: 31 participants
• Primary outcome timeframe: 90 days
• Results posted on: 2016-06-21

Participant Flow

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.

One participant didn't continue on the trial by his own will.

Participant milestones

Measure	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).
Overall Study STARTED	31
Overall Study COMPLETED	31
Overall Study NOT COMPLETED	0

Reasons for withdrawal

Withdrawal data not reported

Baseline Characteristics

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

Baseline characteristics by cohort

Measure	GD Antrodia Camphorata n=31 Participants 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).
Age, Categorical <=18 years	0 Participants n=5 Participants
Age, Categorical Between 18 and 65 years	31 Participants n=5 Participants
Age, Categorical >=65 years	0 Participants n=5 Participants
Sex: Female, Male Female	11 Participants n=5 Participants
Sex: Female, Male Male	20 Participants n=5 Participants
Region of Enrollment Taiwan	31 participants n=5 Participants
Serum glutamic oxaloacetic transaminase SGOT (AST)	16.74 U/L STANDARD_DEVIATION 3.95 • n=5 Participants
Serum glutamic pyruvate transaminase, SGPT (ALT)	17.32 U/L STANDARD_DEVIATION 9.03 • n=5 Participants
Triglycerides (TG)	75.19 mg/dL STANDARD_DEVIATION 35.16 • n=5 Participants
Total protein	6.88 g/dL STANDARD_DEVIATION 0.32 • n=5 Participants
Uric acid	5.79 mg/dL STANDARD_DEVIATION 1.13 • n=5 Participants
Albumin	4.47 g/dL STANDARD_DEVIATION 0.16 • n=5 Participants
Alkaline phosphatase	52.06 U/L STANDARD_DEVIATION 13.18 • n=5 Participants
Direct bilirubin	0.16 mg/dL STANDARD_DEVIATION 0.06 • n=5 Participants
Total bilirubin	0.80 mg/dL STANDARD_DEVIATION 0.28 • n=5 Participants
BUN	10.70 mg/dL STANDARD_DEVIATION 2.53 • n=5 Participants
Cholesterol	169.10 mg/dL STANDARD_DEVIATION 27.05 • n=5 Participants
Creatinine	0.78 mg/dL STANDARD_DEVIATION 0.15 • n=5 Participants
Globulin	2.41 g/dL STANDARD_DEVIATION 0.32 • n=5 Participants
r-glutamyl transpeptidase (r-GT)	14.90 U/L STANDARD_DEVIATION 6.85 • n=5 Participants

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Serum Glutamic Oxaloacetic Transaminase (AST/SGOT)

21.48 U/L Standard Deviation 6.43

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Serum Glutamic Pyruvate Transaminase (ALT/SGPT)

21.94 U/L Standard Deviation 10.10

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Triglycerides (TG)

56.39 mg/dL Standard Deviation 23.17

PRIMARY outcome

Timeframe: 90 days

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

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Total Protein

7.25 g/dL Standard Deviation 0.34

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Uric Acid

5.47 mg/dL Standard Deviation 1.25

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Albumin

4.74 g/dL Standard Deviation 0.20

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Alkaline Phosphatase

55.81 U/L Standard Deviation 14.33

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Direct Bilirubin

0.10 mg/dL Standard Deviation 0.07

PRIMARY outcome

Timeframe: 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.

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Total Bilirubin

0.73 mg/dL Standard Deviation 0.32

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

BUN

9.32 mg/dL Standard Deviation 2.49

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Cholesterol

173.13 mg/dL Standard Deviation 28.09

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Creatinine

0.84 mg/dL Standard Deviation 0.16

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Globulin

2.51 g/dL Standard Deviation 0.29

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

Glucose

80.13 mg/dL Standard Deviation 6.13

PRIMARY outcome

Timeframe: 90 days

Outcome measures

Measure

GD Antrodia Camphorata n=31 Participants 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).

R-glutamyl Transpeptidase (r-GT)

17.42 U/L Standard Deviation 7.76

Adverse Events

GD Antrodia Camphorata

Serious events: 0 serious events

Other events: 0 other events

Deaths: 0 deaths

Serious adverse events

Adverse event data not reported

Other adverse events

Adverse event data not reported

Additional Information

Dr. Choo-Aun Neoh

PingTung Christian Hospital Ruiguang Branch

Phone: 886-8-736-8686

Email: neohca@gmail.com

Results disclosure agreements

• Principal investigator is a sponsor employee
• Publication restrictions are in place