China Journal of Leprosy and Skin Diseases ›› 2020, Vol. 36 ›› Issue (3): 161-164.doi: 10.12144/zgmfskin202003161

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A Single-center, randomized, double-blind, placebo-controlled clinical trial of Kunxian capsule in the treatment of psoriasis vulgaris

LI Buyan1,2, SUN Yonghu1, WU Mei1, YAN Xiaoxiao1, YU Meiling1, ZHANG Zhaoxia1, ZHOU Shengji1, CHU Tongsheng1, SHAN Xiaofeng1, LIU Hong1, SHI Zhongxiang1, TIAN Hongqing1, ZHANG Furen1,2   

  1. 1 Shandong Provincial Hospital for Skin Diseases & Shandong Provincial Institute of Dermatology and Veneorology, Shandong First Medical University & Shandong Academy of Medical Sciences, Jinan 250022, China; 2 Shandong University of Traditional Chinese Medicine, Jinan 250355, China
  • Online:2020-03-15 Published:2020-03-30
  • Contact: ZHANG Furen, E-mail: zhangfuren@hotmail.com

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Abstract: Objective: To evaluate the efficacy and safety of Kunxian capsule in the treatment of psoriasis vulgaris. Methods: The patients were randomly divided into the Kunxian capsule treatment group and the placebo control group according to the predetermined inclusion and exclusion criteria. The PASI score was used to evaluate the drug efficacy. Results: Sixty patients were collected, 30 in each group. The off cases in the treatment group and control group were 3 and 1. The proportion of patients recovered to PASI 50, PASI 75, and PASI 90 in the treatment group was 74.1%, 29.6%, and 14.8% respectively. No any patients recovered to PASI 50, PASI 75 or PASI 90 in the control group. The proportion of the patients with PASI 50, PASI 75 and PASI 90 was significant difference between the two groups (P=0.001，0.002，0.048). Adverse events occurred in 6 patients in the treatment group and 1 patient in the control group. The incidence of total adverse event in the treatment group and control group were 20% and 3.3%, with no significant difference (P>0.05). Conclusion: Kunxian capsule is effective and safe in the treatment of psoriasis vulgaris.

Key words: psoriasis, Kunxian capsule, randomized controlled trial, placebo-controlled trial