Department of Dermatology, Guangdong Provincial Hospital of Chinese Medicine, Guangzhou, China.
Psoriasis Clinical and Basic Research Team, Guangdong Provincial Academy of Chinese Medical Sciences, Guangzhou, China.
BMJ Open. 2017 Nov 3;7(11):e014475. doi: 10.1136/bmjopen-2016-014475.
Psoriasis vulgaris is a common skin disease that is characterised by persistent localised erythematous scaly plaques. Yinxieling is a Chinese herbal formula for psoriasis that has been used for more than 20 years in China. To facilitate application, PSORI-CM01 was developed based on the optimisation and simplification of Yinxieling tablets performed in a previous study and in clinical practice. However, the scientific evidence regarding whether PSORI-CM01 is more effective for psoriasis than the original Yinxieling remains insufficient. Therefore, we designed a randomised clinical trial to investigate the effect, safety and cost-effectiveness of PSORI-CM01 granules compared with those of Yinxieling tablets for the treatment of patients with psoriasis.
This ongoing study is a two-arm parallel, randomised, double-blind, double-dummy clinical trial. Five hundred and fifty-six participants with psoriasis will be recruited and then randomly allocated into two groups in a 1:1 ratio. Participants in PSORI-CM01 group will receive a 5.5 g granule of PSORI-CM01 two times daily and five placebo tablets three times daily for 12 weeks. The participants in the Yinxieling group will receive five Yinxieling tablets three times daily and a placebo granule two times daily for 12 weeks. The primary outcome is the reduction of the Psoriasis Area and Severity Index. The secondary outcomes include relapse rate, Visual Analogue Scale scores, body surface area and the Dermatology Life Quality Index. Cost-effectiveness analysis will be performed from a health and community care provider perspective.
This research protocol had been reviewed and approved by the institutional review boards of three trial centres (Guangdong Provincial Hospital of Chinese Medicine (B2014-026-01), Affiliated Hospital of Tianjin Chinese Medicine Academy (2014-KY-001) and Third Hospital of Hangzhou (B2014-026-01)). The findings will be disseminated to the public through conference presentations and open-access journals.
Chinese Clinical Trial Registry (ChiCTR-TRC-14005185); Pre-results.
寻常型银屑病是一种常见的皮肤病，其特征为持续存在的局限性红斑鳞屑斑块。银屑灵是一种在中国应用超过 20 年的治疗银屑病的中药方剂。为了便于应用，根据之前的研究和临床实践对银屑灵片进行了优化和简化，在此基础上开发了 PSORI-CM01。然而，关于 PSORI-CM01 治疗银屑病是否比原始银屑灵更有效的科学证据仍然不足。因此，我们设计了一项随机临床试验，以调查 PSORI-CM01 颗粒与银屑灵片治疗银屑病患者的疗效、安全性和成本效益。
这是一项正在进行的双臂平行、随机、双盲、双模拟临床试验。将招募 556 名银屑病患者，并以 1:1 的比例随机分为两组。PSORI-CM01 组患者将每日服用 5.5g PSORI-CM01 颗粒两次，同时每日服用 5 片安慰剂三次，共 12 周。银屑灵组患者将每日服用 5 片银屑灵三次，同时每日服用 2 次安慰剂颗粒，共 12 周。主要结局是银屑病面积和严重程度指数的降低。次要结局包括复发率、视觉模拟评分、体表面积和皮肤病生活质量指数。将从健康和社区护理提供者的角度进行成本效益分析。
本研究方案已被三个试验中心的机构审查委员会（广东省中医院[B2014-026-01]、天津中医药大学附属医院[2014-KY-001]和杭州市第三医院[B2014-026-01]）审查和批准。研究结果将通过会议报告和开放获取期刊向公众传播。
中国临床试验注册中心（ChiCTR-TRC-14005185）；预结果。
