Efficacy and safety of Yirui capsule in patients with hyperlipidemia: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial.
Hyperlipidemia is a common disease in China. Although 88.9 % of the Chinese population taking lipid-lowering medications has already used a statin, only 61.5 % of the population has reached the goal of low-density lipoprotein cholesterol. Thus, many patients in China seek help from Traditional Chinese Medicine. Yirui capsules are an innovative Chinese Medicine which are designed to improve the blood lipid state in patients with hyperlipidemia. However, there is still a lack of high-quality evidence from clinical trials to support the application. Therefore, we designed a clinical trial to evaluate the safety and efficacy of Yirui capsules for use by patients with hyperlipidemia.



This is a multicenter, randomized, double-blinded, placebo-controlled trial. Based on lifestyle modification therapy, eligible patients will randomly be assigned to the Yirui capsule or the placebo group. The primary outcome is the percentage of participants who reach the goal of 30 % low-density lipoprotein cholesterol decline at treatment end-point. The secondary outcomes include the changes from baseline to treatment endpoint in low-density lipoprotein cholesterol, total cholesterol, triglyceride, high-density lipoprotein cholesterol, apolipoprotein A, apolipoprotein B, non-high-density lipoprotein cholesterol, MOS 36-Item Short-Form Health Survey scoring, total and individual item scoring of symptomatic grading and quantifying scale, and body mass index.



The main ingredients of the Yirui capsule are perilla oil, Folium Ginkgo (Yinxingye), Radix Salviae miltiorrhizae (Danshen), Fructus Crataegi (Shanzha), Rhizoma Alismatis (Zexie), and Radix Notoginseng (Sanqi), which are expected to improve the blood lipid state. This randomized placebo-controlled trial will comprehensively evaluate the effectiveness and safety of Yirui capsules against hyperlipidemia in the hope of providing a new adjunctive Chinese medicine option for clinical practice in dyslipidemia treatment.



ChiCTR-IOR-15006496 . Registered on 29 May 2015.



WXJ.YRJN-HBT-V1.0 (21 Jan 2015).
School of Chinese Medicine, Hong Kong Baptist University, 4/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.|Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.
Liang
L
Dai
School of Chinese Medicine, Hong Kong Baptist University, 4/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.|Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.
Linda L D
LL
Zhong
Health Management Center, the First Affiliated Hospital of Jinan University, No. 613 Huangpu Avenue West, Tianhe District, Guangzhou, China.
Yan
Y
Cao
Outpatient Department, Guangdong No. 2 Provincial People's Hospital, No. 466 Xingang Middle Road, Haizhu District, Guangzhou, China.
Wei
W
Chen
Department of Cardiology, Hexian Memorial Affiliated Hospital of Southern Medical University, No. 2 East Road of Qinghe, Shiqiao, Panyu District, Guangzhou, China.
Ying
Y
Cheng
Department of Cardiology, the Fifth Affiliated Hospital, Sun Yat-Sen University, No. 52 East Road of Meihua, Xiangzhou District, Zhuhai, China.
Xiu-Fang
XF
Lin
School of Chinese Medicine, Hong Kong Baptist University, 4/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong.|Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China.
Zhao-Xiang
ZX
Bian
School of Chinese Medicine, Hong Kong Baptist University, 4/F, Jockey Club School of Chinese Medicine Building, 7 Baptist University Road, Kowloon Tong, Kowloon, Hong Kong. aipinglu@hkbu.edu.hk.|Hong Kong Chinese Medicine Clinical Study Centre, Hong Kong Baptist University, 7 Baptist University Road, Kowloon Tong, Hong Kong, China. aipinglu@hkbu.edu.hk.
Ai-Ping
AP
Lu
D002214:Capsules; D004311:Double-Blind Method; D004365:Drugs, Chinese Herbal / Q000008:administration & dosage / Q000627:therapeutic use*; D006801:Humans; D006949:Hyperlipidemias / Q000188:drug therapy*; D008055:Lipids / Q000097:blood; D008516:Medicine, Chinese Traditional; D027561:Salvia miltiorrhiza
D002214:Capsules; D004365:Drugs, Chinese Herbal; D008055:Lipids; C544212:shanzha; C028972:dan-shen root extract
Chinese medicine; Hyperlipidemia; Randomized controlled trial; Yirui capsules