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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.
Safety Measurement:
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.
Study design is multiple-dose, open-label study
The study site is Pingtung Christian Hospital Ruiguang Branch.
Safety Measurement:
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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). |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| GD Antrodia camphorata | Dietary Supplement | Three 500mg capsules per oral dose, twice daily with an interval of 12 hours for 90 days |
|
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Choo-Aun Neoh | PingTung Christian Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| PingTung Christian Hospital | Pingtung City | Taiwan |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 12744658 | Background | 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. |
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One participant didn't continue on the trial by his own will.
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.
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| ID | Title | Description |
|---|---|---|
| FG000 | 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). |
| Title | Milestones | Reasons Not Completed | ||||||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Overall Study |
|
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).
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| ID | Title | Description |
|---|---|---|
| BG000 | 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). |
| Units | Counts |
|---|---|
| Participants |
|
| Title | Description | Population Description | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Denominator Units Selected | Denominators | Classes |
|---|---|---|---|---|---|---|---|---|---|
| Age, Categorical | Count of Participants |
| Type | Title | Description | Population Description | Reporting Status | Anticipated Posting Date | Parameter Type | Dispersion Type | Unit of Measure | Calculate Percentage | Time Frame | Units Analyzed | Denominator Units Selected | Arm/Group Information | Denominators | Classes | Analyses | ||||||||
|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|---|
| Primary | Serum Glutamic Oxaloacetic Transaminase (AST/SGOT) | Posted | Mean | Standard Deviation | U/L | 90 days |
|
|
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| ID | Title | Description | Deaths (Affected) | Deaths (At Risk) | Serious Events (Affected) | Serious Events (At Risk) | Other Events (Affected) | Other Events (At Risk) |
|---|---|---|---|---|---|---|---|---|
| EG000 | 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). |
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| Title | Organization | Phone | Extension | |
|---|---|---|---|---|
| Dr. Choo-Aun Neoh | PingTung Christian Hospital Ruiguang Branch | 886-8-736-8686 | 5310 | neohca@gmail.com |
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| 90 days |
| BUN | 90 days |
| Cholesterol | 90 days |
| Creatinine | 90 days |
| Globulin | 90 days |
| Glucose | 90 days |
| R-glutamyl Transpeptidase (r-GT) | 90 days |
| Participants |
|
| Sex: Female, Male | Count of Participants | Participants |
|
| Region of Enrollment | Number | participants |
|
| Serum glutamic oxaloacetic transaminase SGOT (AST) | 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. | Mean | Standard Deviation | U/L |
|
| Serum glutamic pyruvate transaminase, SGPT (ALT) | 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. | Mean | Standard Deviation | U/L |
|
| Triglycerides (TG) | 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. | Mean | Standard Deviation | mg/dL |
|
| Total protein | 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. | Mean | Standard Deviation | g/dL |
|
| Uric acid | 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. | Mean | Standard Deviation | mg/dL |
|
| Albumin | 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. | Mean | Standard Deviation | g/dL |
|
| Alkaline phosphatase | 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. | Mean | Standard Deviation | U/L |
|
| Direct bilirubin | 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. | Mean | Standard Deviation | mg/dL |
|
| Total bilirubin | 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. | Mean | Standard Deviation | mg/dL |
|
| BUN | 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. | Mean | Standard Deviation | mg/dL |
|
| Cholesterol | 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. | Mean | Standard Deviation | mg/dL |
|
| Creatinine | 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. | Mean | Standard Deviation | mg/dL |
|
| Globulin | 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. | Mean | Standard Deviation | g/dL |
|
| r-glutamyl transpeptidase (r-GT) | 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. | Mean | Standard Deviation | U/L |
|
|
| Primary | Serum Glutamic Pyruvate Transaminase (ALT/SGPT) | Posted | Mean | Standard Deviation | U/L | 90 days |
|
|
|
| Primary | Triglycerides (TG) | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
|
|
| Primary | Total Protein | The total protein test measures the total amount of two classes of proteins in the blood, albumin and globulin. | Posted | Mean | Standard Deviation | g/dL | 90 days |
|
|
|
| Primary | Uric Acid | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
|
|
| Primary | Albumin | Posted | Mean | Standard Deviation | g/dL | 90 days |
|
|
|
| Primary | Alkaline Phosphatase | Posted | Mean | Standard Deviation | U/L | 90 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
|
|
| Primary | 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. | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
|
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| Primary | BUN | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
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| Primary | Cholesterol | Posted | Mean | Standard Deviation | mg/dL | 90 days |
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|
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| Primary | Creatinine | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
|
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| Primary | Globulin | Posted | Mean | Standard Deviation | g/dL | 90 days |
|
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| Primary | Glucose | Posted | Mean | Standard Deviation | mg/dL | 90 days |
|
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| Primary | R-glutamyl Transpeptidase (r-GT) | Posted | Mean | Standard Deviation | U/L | 90 days |
|
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| 0 |
| 31 |
| 0 |
| 31 |
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