A Randomized, Double-Blind, Placebo-Controlled Parallel Study on the Efficacy and Safety of Centella asiatica L. Extract for Reducing Alanine Transaminase (ALT) Level in Subjects with Elevated ALT

Yong Joon Jeong,Se Chan Kang,Hyelin Jeon

doi:10.3390/app112311498

Yong Joon Jeong, Se Chan Kang + Show 1 more

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https://doi.org/10.3390/app112311498

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Journal: Applied sciences	Publication Date: Dec 4, 2021
Citations: 1	License type: CC BY 4.0

Affiliation: Kyung Hee University

Abstract

The liver is an important organ that detoxifies various metabolites, synthesizes proteins, and produces biochemicals necessary for life. There are many medications on the market to treat liver diseases, but these can be a strain on the liver due to the need for a detoxification process in the organ. Herbal medicines are replacing synthetic drugs. In the present study, we aimed to evaluate the efficacy and safety of Centella aisatica L. extract for reducing alanine transaminase (ALT) levels using a randomized, double-blind, placebo-controlled parallel study. Investigators performed a clinical trial in which an herbal treatment was administered every morning for 12 weeks to 80 patients in two groups. The study protocol number was SYN/RM/CA-008. The results demonstrated improved ALT levels with a positive change in the investigational product (IP) group (−19.9) compared to the placebo group (1.8) (p < 0.0001). In addition, IP treatment was safe and non-toxic. The current data indicate that CA-HE50 exhibits clinically significant changes for all hepatoprotective efficacy parameters, suggesting potential for development and applicability as a hepatoprotective substance.

Highlights

The liver is one of the essential organs in the body that regulates various processes.Among them, the functions of metabolism, secretion, storage, and detoxification of endogenous and exogenous substances are essential [1]
Liver disease or damage caused by viral infections, inflammation, toxic substances, and genetics can lead to liver failure [2]
This study was conducted in accordance with the Declaration of Helsinki (52nd World Medical Association General Assembly, Edinburgh, Scotland, October 2000), and this human application trial was conducted in accordance with The International Conference on Harmonization (ICH) guidelines on

Summary

Introduction

The liver is one of the essential organs in the body that regulates various processes. The functions of metabolism, secretion, storage, and detoxification of endogenous and exogenous substances are essential [1]. Due to its vital function, the liver is important, and disease of the organ constitutes a major threat to public health. Liver disease or damage caused by viral infections, inflammation, toxic substances, and genetics can lead to liver failure [2]. Liver failure refers to a condition in which the liver is unable to perform its normal synthetic and metabolic functions. Types of liver failure include acute and chronic failure [3]. Acute liver failure can be associated with rapidly progressing multi-organ failure and fatal complications. Due to its widespread effects, liver failure can induce systemic inflammatory responses [4], high energy expenditure, and catabolism [5]

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