Clinical and Biological Efficacy of Thai Herbal Blood Lipid-Lowering Formulation for Borderline Hyperlipidemia: A Double-Blind Multicenter Randomized Controlled Trial

BackgroundTraditional Thai herbal medicine represents an alternative and complementary approach for managing hyperlipidemia, according to its low toxicity and advantageous benefits. However, there is limited clinical data for Thai herbal medicine formulations for hyperlipidemia.ObjectivesThe present study aimed to evaluate the biological and clinical efficacy of Thai herbal formulation for lowering blood lipids in patients with borderline hyperlipidemia.Materials and methodsThe chemical profile, <i>in vitro</i> antioxidant activity, pancreatic lipase inhibition, and cytotoxicity tests were evaluated in the aqueous and ethanol extracts of Thai herbal formulation. The clinical efficacy and safety of Thai herbal formulation for reducing blood lipids were assessed in patients with borderline hyperlipidemia during a 12-week period.ResultsThe main chemical constituents of Thai herbal formulation, including (+)-chebulic acid, 4-glucogallic acid, gallic acid, ellagic acid, piscidic acid, and 6-gingerol, demonstrated anti-oxidant and pancreatic lipase inhibitory effects. In cytotoxicity testing, the aqueous extracts exhibited no inhibitory effect on L929 cells and Vero cells (IC₅₀ values above 80 μg/mL), whereas the ethanol extracts presented IC₅₀ values of 18.59 ± 0.58 µg/mL in Vero cells and 39.86 ± 0.02 µg/mL in L929 cells. The clinical investigation revealed that the Thai herbal formulation significantly decreased total cholesterol and low-density lipoprotein levels (<i>P</i> < 0.05), and additionally reduced triglycerides and elevated high-density lipoprotein cholesterol, in comparison to the control group after 12 weeks, thereby demonstrating its efficacy in hyperlipidemia management.ConclusionThe findings indicated that the Thai herbal formulation exhibited potential as a herbal therapeutic approach for borderline hyperlipidemia management.