文献类型：期刊文献

英文题名：Efficacy and Safety of Jueyin Granules for Patients with Mild-to-Moderate Psoriasis Vulgaris: Protocol for a Multicenter Randomized Placebo-Controlled Trial

作者：Li, Su[1];Zhang, Cang[2];Zhang, Hong-Ya[3];Zhou, Meng[4];Wang, Si-Nong[5];Xu, Rong[1];Zhou, Dong-Mei[2];Ji, Yun-Run[2];Lv, Jing-Jing[2];Yin, Qing-Feng[6];Wang, Rui-Ping[7];Li, Wei[4];Liu, Yan-Ping[5];Wang, Jian-Feng[3];Li, Bin[1,8];Li, Xin[1,8]

第一作者：Li, Su

通信作者：Li, B[1];Li, X[1];Li, B[2];Li, X[2]

机构：[1]Shanghai Univ Tradit Chinese Med, Yueyang Hosp Integrated Tradit Chinese & Western, Dept Dermatol, Shanghai 200437, Peoples R China;[2]Capital Med Univ, Dept Dermatol, Beijing Hosp Tradit Chinese Med, Beijing 100010, Peoples R China;[3]Anhui Univ Tradit Chinese Med, Dept Dermatol, Affiliated Hosp 1, Hefei 230031, Anhui, Peoples R China;[4]Guangxi Zhuang Autonomous Reg Inst Dermatol Preve, Nanning 530007, Guangxi, Peoples R China;[5]Gansu Univ Tradit Chinese Med, Dept Dermatol, Affiliated Hosp, Lanzhou 730000, Gansu, Peoples R China;[6]Nanjing Univ Tradit Chinese Med, Jiangsu Famous Med Technol Co Ltd, Nanjing 210029, Peoples R China;[7]Shanghai Univ Tradit Chinese Med, Yueyang Hosp Integrated Tradit Chinese & Western, Off Clin Res Ctr, Shanghai 200437, Peoples R China;[8]Shanghai Acad Tradit Chinese Med, Inst Dermatol, Shanghai 201203, Peoples R China

第一机构：Shanghai Univ Tradit Chinese Med, Yueyang Hosp Integrated Tradit Chinese & Western, Dept Dermatol, Shanghai 200437, Peoples R China

通信机构：[1]corresponding author), Shanghai Univ Tradit Chinese Med, Yueyang Hosp Integrated Tradit Chinese & Western, Dept Dermatol, Shanghai 200437, Peoples R China;[2]corresponding author), Shanghai Acad Tradit Chinese Med, Inst Dermatol, Shanghai 201203, Peoples R China.

年份：2020

卷号：2020

外文期刊名：EVIDENCE-BASED COMPLEMENTARY AND ALTERNATIVE MEDICINE

收录：;Scopus(收录号：2-s2.0-85084043947);WOS:【SCI-EXPANDED(收录号:WOS:000529293200002)】；

基金：This project was supported by the National Key Research and Development Program of China (grant no. 2018YFC1705302), NSFC of China (nos. 81874470 and 81973860), Shanghai Development Office of TCM (nos. shslczdzk05001, ZY(2018-2020)-FWTX-1008, ZY(2018-2020)-CCCX-2004-08, and ZY(2018-2020)-FWTX-4010), Shanghai Municipal Health Commission (grant no. shslczdzk05001), and Shanghai Science and Technology Committee (no. 18401932300).

语种：英文

摘要：Introduction. The etiology and pathogenesis of psoriasis are complex. Blood-heat syndrome is the core pathogenesis of psoriasis. Based on theories of Chinese medicine (CM), heat-clearing and blood-cooling (HCBC) are the primary treatment. Very few studies have investigated the pharmacological mechanism of the CM HCBC method for treating psoriasis. This multicenter randomized controlled trial will focus on treating psoriasis blood-heat syndrome with the HCBC method using Jueyin granules (JYKL). This will be an objective and standardized evaluation of the efficacy, safety, and reproducibility of the HCBC method to obtain objective evidence meeting international standards that aim to establish a clinical standard suitable for the popular application of CM for treating psoriasis. Methods and Analysis. A five-center randomized double-blind placebo-controlled clinical design will be used in this study. At least 196 participants will be randomly assigned to receive either JYKL or placebo treatment approximately 30 minutes after meals in the morning and evening (one sachet per time, twice daily for 8 consecutive weeks). The study duration will be 17 weeks, including 1 week of screening, 8 weeks of intervention, and 8 weeks of follow-up. The patients will be evaluated every 2 weeks, and the measures will be compared with baseline values. The primary outcome measure will be the psoriasis lesion area severity index. We will also observe the recurrence rate, body surface area, physician global assessment, dermatology life quality index, quality of life index, visual analogue scale score, CM symptom score, combined drug use, and adverse events. This trial is registered with .