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

• Published in: Applied sciences Vol. 11; no. 23; p. 11498
• Main Authors: Jeong, Yong Joon, Jeon, Hyelin, Kang, Se Chan
• Format: Journal Article
• Language: English
• Published: Basel MDPI AG 01.12.2021
• Subjects: alanine aminotransaminase; Antioxidants; Centella asiatica L; Dietary guidelines; Double-blind studies; Ethics; functional food; Hepatitis; hepatoprotection; human application trial; Informed consent; Liver diseases; Medical research; Metabolism; Participation; Prescription drugs; Regulatory approval; India
• ISSN: 2076-3417; 2076-3417
• DOI: 10.3390/app112311498

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.