Efficacy and safety of a combined extract of Paeonia lactiflora and Salvia miltiorrhiza (USCP-SL22) on fasting triglyceride reduction in adults: A randomized, double-blind, placebo-controlled trial

Abstract

Elevated fasting triglyceride (TG) levels are a major risk factor for cardiovascular disease. This multicenter, randomized, double-blind, placebo-controlled trial evaluated the efficacy and safety of a combined extract of Paeonia lactiflora and Salvia miltiorrhiza (USCP-SL22) in adults with borderline-to-high fasting TG levels. Adults aged 19 to 80 years with fasting TG levels of 130 to 400 mg/dL were randomly assigned to receive 400 mg of USCP-SL22 or placebo twice daily for 12 weeks. The primary outcome was the change in fasting TG levels. Secondary outcomes included lipid metabolism markers, carotid intima-media thickness (IMT), blood pressure, body mass index, and high-sensitivity C-reactive protein. In conclusion, 12-week supplementation with USCP-SL22 significantly reduced fasting TG levels compared with the placebo group. While exploratory improvements were noted in specific secondary parameters, broader lipid profiles and vascular indices, including carotid IMT, did not show significant between-group differences. These findings suggest that USCP-SL22 was well tolerated and may serve as a functional ingredient for managing elevated fasting TG levels.