Description Module
The Description Module contains narrative descriptions of the clinical trial, including a brief summary and detailed description. These descriptions provide important information about the study's purpose, methodology, and key details in language accessible to both researchers and the general public.
Description Module path is as follows:
Study -> Protocol Section -> Description Module
Description Module
Ignite Creation Date:
2025-12-24 @ 11:25 PM
Ignite Modification Date:
2025-12-24 @ 11:25 PM
NCT ID:
NCT01007656
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.
Study:
NCT01007656
Study Brief:
Protocol Section:
NCT01007656