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.

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.

• Authors: Guanru Li, Liyun Sun, Yue Qiu, Yaquan Hou, Libo Du, Kaixuan Zhao, Jiali Qian, Jiuli Liu, Tengfei Ma
• Journal: Medicine (Medicine (Baltimore)) Vol. 100 Issue 52 Pg. e28178 (Dec 30 2021) ISSN: 1536-5964 [Electronic] United States
• PMID: 34967353 (Publication Type: Clinical Trial Protocol, Journal Article)
• Copyright: Copyright © 2021 the Author(s). Published by Wolters Kluwer Health, Inc.

Chemical References

• Ointments

Topics

• Chronic Disease
• Double-Blind Method
• Humans
• Neoplasm Recurrence, Local
• Ointments (administration & dosage, adverse effects)
• Psoriasis (complications, drug therapy)
• Quality of Life
• Randomized Controlled Trials as Topic
• Syndrome
• Treatment Outcome