Safety Assessment of Oral Lysiphyllum strychnifolium Aqueous Extract in Healthy Volunteers

Abstract

Background: Lysiphyllum strychnifolium (LS), widely known as Ya nang daeng in Thailand, is a traditional herbal remedy that has long been used to promote health and treat diverse health conditions, especially detoxification, by alleviating the severity of symptoms and lowering the risks associated with toxic exposures. Although it is extensively used in Thailand, human safety studies have been lacking. Thus, this study aimed to examine the safety of using LS capsules in healthy participants through a Phase I clinical trial. Objective: This study aimed to investigate the safety of aqueous extract of LS in twenty-four healthy Thai participants. Method: The participants were received 1,000 mg of LS aqueous extract each morning before their meals for seven days. All participants were examined safety assessment including history taking, physical examination, and laboratory tests at day 0, 8 and 14 (follow-up). Results: The findings showed that there were no significant side effects or abnormalities found during the history taking, physical examination, or laboratory evaluation. Particularly, when compared to baseline, participants who received LS experienced statistically significant reductions in blood sugar, triglyceride, LDL cholesterol, and creatinine (P < 0.05), but still within normal ranges. Conclusions: Dietary supplementation with 1,000 mg of LS aqueous extract per day may have a beneficial effect on blood sugar and cholesterol management while remaining safe for healthy people.