옻나무-두충추출혼합물(ILF-RE)의 간기능 개선에 대한 유효성 및안전성을 평가하기 위한 무작위배정 이중눈가림 인체적용시험 (Randomized Double-blind Human Trial to Evaluate Efficacy and Safetyof Rhus verniciflua Stokes (Lacca Sinica Exsiccata) and Eucommia ulmoides Oliver (Eucommiae Cortex) Extract Combination (ILF-RE) on I)

서지정보

· 발행기관 : 대한본초학회
· 수록지 정보 : 대한본초학회지 / 35권 / 1호 / 45 ~ 55페이지
· 저자명 : 윤영, 백향임, 진희연, 정다영, 신뢰, 주종천, 박수정

초록

Objectives：The purpose of this study is to determine whether Rhus verniciflua Stokes with Latin name Lacca Sinica Exsiccata, and Eucommia ulmoides Oliver with Latin name Eucommiae Cortex Extract Combination (ILF-RE) improves laboratory test results in participants with liver function disorder.
Methods：This study was conducted at Woosuk university Korean medicine hospital where participants with high serum alanine transaminase (ALT) levels from 45 to 135 U/L were enrolled. Subjects received ILF-RE 3.6 g (1.2 g/day as ILF-RE) or placebo 3.6 g for 12 weeks. It was confirmed that urushiol was not detected in ILF-RE. The primary outcomes were the decrement degree of serum ALT and gamma-glutamyl transferase (GGT) levels between two groups. The secondary outcomes were the decrement degree of serum aspartate transaminase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LD), total bilirubin, total cholesterol, triglyceride (TG) and fatty liver index (FLI) levels between two groups. Adverse events, skin prick tests, laboratory tests, and vital signs were observed and analyzed to confirm the safety of ILF-RE.
Results：In the ILF-RE group, the liver function index ALT, GGT, lipid metabolism index TG, and fatty liver index FLI were significantly decreased compared to the placebo group. There was no significant difference in ILF-RE group in terms of adverse events, severe adverse events, skin prick test, laboratory test, and vital signs compared with placebo group.
Conclusions：ILF-RE was found to be effective in improving liver function. In addition, no clinically significant adverse events or body changes were observed during this study.

영어초록

Objectives：The purpose of this study is to determine whether Rhus verniciflua Stokes with Latin name Lacca Sinica Exsiccata, and Eucommia ulmoides Oliver with Latin name Eucommiae Cortex Extract Combination (ILF-RE) improves laboratory test results in participants with liver function disorder.
Methods：This study was conducted at Woosuk university Korean medicine hospital where participants with high serum alanine transaminase (ALT) levels from 45 to 135 U/L were enrolled. Subjects received ILF-RE 3.6 g (1.2 g/day as ILF-RE) or placebo 3.6 g for 12 weeks. It was confirmed that urushiol was not detected in ILF-RE. The primary outcomes were the decrement degree of serum ALT and gamma-glutamyl transferase (GGT) levels between two groups. The secondary outcomes were the decrement degree of serum aspartate transaminase (AST), alkaline phosphatase (ALP), lactate dehydrogenase (LD), total bilirubin, total cholesterol, triglyceride (TG) and fatty liver index (FLI) levels between two groups. Adverse events, skin prick tests, laboratory tests, and vital signs were observed and analyzed to confirm the safety of ILF-RE.
Results：In the ILF-RE group, the liver function index ALT, GGT, lipid metabolism index TG, and fatty liver index FLI were significantly decreased compared to the placebo group. There was no significant difference in ILF-RE group in terms of adverse events, severe adverse events, skin prick test, laboratory test, and vital signs compared with placebo group.
Conclusions：ILF-RE was found to be effective in improving liver function. In addition, no clinically significant adverse events or body changes were observed during this study.

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