Oral Chinese herbal medicine for psoriasis vulgaris: protocol for a randomised, double-blind, double-dummy, multicentre clinical trial.
Oral Chinese herbal medicine for psoriasis vulgaris: protocol for a randomised, double-blind, double-dummy, multicentre clinical trial.
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DOI：
10.1136/bmjopen-2016-014475
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发表时间：
2017-11-03
期刊：
影响因子：
2.9
通讯作者：
Deng H
中科院分区：
文献类型：
--
作者：
Deng J;Yao D;Lu C;Wen Z;Yan Y;He Z;Wu H;Deng H
寻常型银屑病是一种常见的皮肤病，其特征是持续的局部鳞状斑块。银屑灵是一种治疗银屑病的中草药配方，在中国已经使用了20多年。为了便于应用，PSORI-CM 01是在先前研究和临床实践中对银屑灵片进行优化和简化的基础上开发的。然而，关于PSORI-CM 01是否比原来的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，以观察PSORI-CM 01颗粒剂与银屑灵片相比治疗银屑病患者的疗效、安全性和成本-效果。这项正在进行的研究是一项两组平行、随机、双盲、双模拟临床试验。将招募五十六例银屑病受试者，然后以1：1的比例随机分配至两组。PSORI-CM 01组受试者将接受5.5 g颗粒PSORI-CM 01每日两次和5片安慰剂片剂每日三次，持续12周。银屑灵组的参与者将接受5片银屑灵片剂，每天3次，以及安慰剂颗粒，每天2次，持续12周。主要结局是银屑病面积和严重程度指数的降低。次要结果包括复发率、视觉焦虑量表评分、体表面积和皮肤病生活质量指数。将从卫生和社区保健提供者的角度进行成本效益分析。本研究方案已经过三个试验中心（广东省中医院（B2014-026-01）、天津中医药科学院附属医院（2014-KY-001）和杭州市第三医院（B2014-026-01））的机构审查委员会的审查和批准。调查结果将通过会议介绍和开放获取期刊向公众传播。中国临床试验登记研究（ChiCTR-TRC-14005185）;预结果。
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.
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