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

NCT ID: NCT01007656

Last Updated: 2016-06-21

Basic Information

• Recruitment Status: COMPLETED
• Clinical Phase: NA
• Total Enrollment: 31 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2009-11-30
• Study Completion Date: 2010-03-31

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.

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.

Conditions

Healthy

Study Design

• Allocation Method: NA
• Intervention Model: SINGLE_GROUP
• Blinding Strategy: NONE

Study Groups

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).

Group Type: EXPERIMENTAL

GD Antrodia camphorata

Intervention Type: DIETARY_SUPPLEMENT

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

Interventions

GD Antrodia camphorata

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

Intervention Type: DIETARY_SUPPLEMENT

Eligibility Criteria

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.

• Minimum Eligible Age: 20 Years
• Maximum Eligible Age: 40 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: Yes

Sponsors

Golden Biotechnology Corporation

INDUSTRY

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Principal Investigators

Choo-Aun Neoh

Role: PRINCIPAL_INVESTIGATOR

PingTung Christian Hospital

Locations

PingTung Christian Hospital

Pingtung City, , Taiwan

Countries

Taiwan

References

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.

Reference Type: BACKGROUND

PMID: 12744658 (View on PubMed)

Other Identifiers

IRC01080923

Identifier Type: -

Identifier Source: org_study_id