Evaluation of the safety and efficacy of Chinese medicine in people with asymptomatic hyperuricemia: Protocol for a prospective, double-blinded, randomized, placebo controlled clinical trial

Autor: Jia-qi Wu, Ying-yan Zhou, Xiao-hong He, Qiao-wen Yang, Jing-yao Yan
Rok vydání: 2021
Předmět:
DOI: 10.21203/rs.3.rs-395566/v1
Popis: BackgroundHyperuricemia increases the risk of gout and cardiovascular complications. Studys show that Chinese medicine can decrease uric acid through multiple targets, but many of these studys is conducted on animal, because the lack of a consistent prescription and mechanism.So we design this research to study whether Chinese medicine is really effective and which target is essential.MethodsThis study is a prospective, double-blinded, randomized, placebo controlled clinical trial. From March 2020 to December 2021.30 asymptomatic hyperuricemia people will be recruiting and assigned to either Chinese medicine group or placebo group, each group will have 15 subjects.During the 12-week observation period,there will be 4 times of visits.The decline in the uric acid is the main outcome measure, urinary uric acid,inflammatory biomarkers and other index that may involve in lowing uric acid are the secondary outcome measures.DiscussionThis study will probe the effect of Chinese medicine treatment on hyperuricemia, and explore possible therapeutic mechanisms. By performing this trial,we hoping to provide evidence and data to support further large clinical studies.Trial registration:ChiCTR2000038575. Registered on September 24, 2020.
Databáze: OpenAIRE