Department of TCM Internal Medicine, Shanghai Pudong Hospital Affiliated to Fudan University, 2800 Gongwei Road, Shanghai, 201399, China.
Department of Nephrology, Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, 528 Zhangheng Road, Shanghai, 201203, China.
Trials. 2022 Jan 3;23(1):1. doi: 10.1186/s13063-021-05959-2.
Jiangniaosuan formula (JNSF) is commonly used in China for treating hyperuricemia, but there is little research-based evidence to support its use. This randomized controlled trial aims to assess the efficacy and safety of JNSF.
A total of 72 patients with hyperuricemia will be selected and randomly assigned in a ratio of 1:2 to receive either Western medicine, i.e., febuxostat 40 mg (WG group; n = 24), or Chinese herbal medicine, i.e., Jiangniaosuan formula + febuxostat 20 mg (WJNSG group; n = 48). After 12 weeks, the WJNSG will be randomly divided into two groups of 24 patients each; one group (WJNSG; n = 24) still will receive febuxostat 20 mg + Jiangniaosuan formula, and the other group (JNSG; n = 24) will continue to receive Jiangniaosuan formula + placebo. Participants will be followed up at 4-week intervals. The primary outcome will be the change in serum uric acid level, and the secondary outcome will be the change in traditional Chinese medicine (TCM) syndrome scores. Serum creatinine, blood glucose, and insulin levels will also be measured.
We hypothesize that patients with hyperuricemia will benefit from JNSF. This study will provide evidence-based recommendations for clinicians.
The results will be published in a peer-reviewed journal and disseminated by academic conferences. The datasets analyzed during the current study are available from the corresponding author on reasonable request.
Chinese Clinical Trials Register ChiCTR2000041083 . Registered on 3 May 2021. The protocol version number is V3.0, 20210301.
降尿酸方（JNSF）在中国常用于治疗高尿酸血症，但缺乏基于研究的证据支持其应用。本随机对照试验旨在评估 JNSF 的疗效和安全性。
共纳入 72 例高尿酸血症患者，按照 1:2 的比例随机分为西药组（n = 24，给予别嘌醇 40mg）和中药组（n = 48，给予降尿酸方+别嘌醇 20mg）。治疗 12 周后，中药组再随机分为两组，每组 24 例；一组（WJNSG 组）继续给予别嘌醇 20mg+降尿酸方，另一组（JNSG 组）继续给予降尿酸方+安慰剂。4 周后随访。主要结局为血清尿酸水平的变化，次要结局为中医证候评分的变化。同时检测血清肌酐、血糖和胰岛素水平。
我们假设高尿酸血症患者将从 JNSF 中获益。本研究将为临床医生提供循证建议。
研究结果将发表在同行评议的期刊上，并通过学术会议进行传播。有需要时可向通讯作者索取研究期间分析的数据集。
中国临床试验注册中心，ChiCTR2000041083，于 2021 年 5 月 3 日注册。方案版本号为 V3.0，20210301。
