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- W4256202226 abstract "Abstract Background Plaque psoriasis is a refractory inflammatory skin disease. Traditional Chinese medicine (TCM) and Western medicine (WM) therapies commonly used to treat plaque psoriasis have distinct characteristics and advantages. Although a combination of TCM and WM therapies adjusted to the clinical situation is widely used, there have been no systematic studies on the hierarchical selection of treatment combinations according to the severity of skin lesions. We therefore designed a randomized clinical trial to focus on the sequence of internal and external treatments in patients with mild-to-moderate plaque psoriasis and sought to optimize the integrated Chinese and Western medicine for treatment of patients with severe plaque psoriasis, so as to achieve high-level clinical evidence and establish treatment norms for the integrated use of Chinese and Western medicines. Methods In the proposed multi-center, single-blinded, randomized, controlled trial, 108 patients with mild-to-moderate plaque psoriasis will be randomly assigned to two groups in a 1:1 ratio to receive internal and external TCM treatments, respectively, and 270 patients with severe plaque psoriasis will be randomly assigned to three groups in a 1:1:1 ratio to receive treatment with TCM, WM, and integrated Chinese and Western medicine, respectively. All enrolled patients will receive 8 weeks of treatment and 8 weeks of follow-up. The primary outcome will be an evaluation of efficacy and relapse rate based on the Psoriasis Area and Severity Index . Secondary outcome measures will include a determination of affected body surface area, physician’s global assessment, pruritus scores determined using a visual analogue scale, TCM symptom score, dermatology life quality Index, patient-reported quality of life score, and incidence of serious adverse events. Discussion This study will provide a high level of clinical evidence for internal and external TCM treatment optimization and will contribute to establishing norms for the integration of Chinese and Western medicines." @default.
- W4256202226 created "2022-05-12" @default.
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- W4256202226 date "2019-09-24" @default.
- W4256202226 modified "2023-09-26" @default.
- W4256202226 title "Study protocol of Our Choice: a randomized controlled trial for optimal implementation of psoriasis treatment by the integration of Chinese and western medicine" @default.
- W4256202226 doi "https://doi.org/10.21203/rs.2.14858/v1" @default.
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