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. 2021 Dec 30;100(52):e28178.
doi: 10.1097/MD.0000000000028178.

Efficacy of nano-modified Runji ointment in the treatment of mild and moderate psoriasis with blood dryness syndrome: a study protocol for a double-blind randomized controlled trial

Guanru Li  1 , Liyun Sun  2 , Yue Qiu  2 , Yaquan Hou  3 , Libo Du  4 , Kaixuan Zhao  5 , Jiali Qian  1 , Jiuli Liu  1 , Tengfei Ma  1
Affiliations

Efficacy of nano-modified Runji ointment in the treatment of mild and moderate psoriasis with blood dryness syndrome: a study protocol for a double-blind randomized controlled trial

Guanru Li et al. Medicine (Baltimore). .

Abstract

Introduction: Psoriasis is a common, recurrent, immune skin disease, which seriously affects patients' quality of life. In clinical practice, modified Runji ointment can effectively treat mild-to-moderate psoriasis with blood dryness syndrome, but there is a lack of high-quality evidence-based medical evidence. This trial aims to evaluate the efficacy and safety of nano-modified Runji ointment in the treatment of mild-to-moderate psoriasis with blood dryness syndrome.

Methods/design: This study will be a randomized double-blind placebo-controlled trial. A total of 80 patients will be recruited and randomly divided into an intervention group (nano-modified Runji ointment group) and a placebo group at a ratio of 1:1. All included patients will receive 8 weeks of nano-modified Runji ointment or placebo ointment respectively, twice a day. The primary outcome will be the change in psoriasis area and disease severity index score at week 8 compared to baseline. The secondary outcomes will be rash area score, pruritus score, Dermatology Life Quality Index score, traditional Chinese medicine symptom score and adverse events.

Discussion: This study may provide high-quality evidence for the efficacy of nano-modified Runji ointment in the treatment of mild to moderate psoriasis with blood dryness syndrome. The results of this study will be published in peer-reviewed journals.

Trial registration: ChiCTR, ChiCTR2000034292. Registered July 1, 2020, https://www.chictr.org.cn/edit.aspx?pid=55884&htm=4.

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Conflict of interest statement

The authors have no conflicts of interest to disclose.

Figures

Figure 1
Figure 1
The flow chart of the trial. ALT = alanine aminotransferase, AST = aspartate aminotransferase, BUN = blood urea nitrogen, Cr = serum creatinine.
See this image and copyright information in PMC

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