Evaluation of the safety and efficacy of a Fuling-Zexie decoction for people with asymptomatic hyperuricemia: protocol for a prospective, double-blinded, randomized, placebo-controlled clinical trial

BACKGROUND: Hyperuricemia increases the risk of gout and cardiovascular complications, and how to manage asymptomatic hyperuricemia is controversial. Randomized controlled trials and comparative studies are needed to guide management and treatment. Studies show that Chinese medicine can decrease uric acid through multiple targets, but many of these studies have been conducted in animals because of the lack of a consistent prescription and mechanism. Therefore, we designed this research to study whether Chinese medicine is truly effective and which target is essential by using an approved prescription of a Fuling-Zexie decoction to further guide large sample experiments to determine whether Chinese medicine can reduce the long-term incidence of gout and cardiovascular events. METHODS: This pilot study is a prospective, double-blinded, randomized, placebo-controlled clinical trial developed from March 2020 to December 2021. Thirty people with asymptomatic hyperuricemia will be recruited and assigned to either the Chinese medicine group or placebo group, and each group will have 15 subjects. During the 12-week observation period, there will be 4 visits. The decline in uric acid is the main outcome measure, and urinary uric acid, inflammatory biomarkers, and other indices that may be involved in lowering uric acid are the secondary outcome measures. DISCUSSION: This study will probe the effect of Chinese medicine treatment on hyperuricemia and explore possible therapeutic mechanisms. By performing this trial, we hope to provide evidence and data to support further large clinical studies. TRIAL REGISTRATION: ChiCTR2000038575. Registered on September 24, 2020. SUPPLEMENTARY INFORMATION: The online version contains supplementary material available at 10.1186/s13063-022-06479-3.