The Efficacy and Safety of Longmu Tang Granule for Treating Atopic Dermatitis: Study Protocol for a Single-Centered, Double-Blinded, Randomized Controlled Trial

Abstract

Background: Atopic dermatitis (AD) is a chronic relapsing skin disease that has long-term adverse effects on the physical and mental health of children. Current treatments mainly include anti-inflammatory, antibacterial, and anti-allergic interventions, systemic therapy and recently emerging targeted agents. However, these treatments have limited effectiveness and bothersome side effects. The use of traditional Chinese medicine (TCM) is associated with safety and improvements in the clinical symptoms and quality of life of AD patients. However, the poor quality and heterogeneity of studies have not led to sufficient conclusions. Therefore, we will conduct a randomized, controlled, double-blind clinical trial to confirm the efficacy and safety of Longmu Tang granule for the treatment of AD.Methods: This is a single-center, double-blind, randomized, controlled clinical trial. A total of 60 participants will be randomly assigned (1:1) to receive Longmu Tang granule or placebo granule for 8 weeks. The primary outcome is the index of Scoring Atopic Dermatitis (SCORAD). The second outcomes include the children's Dermatology Life Quality Index (CDLQI) and the Number Cancel Test (NCT), and long-term efficacy. Mechanistic outcome is the serum level of inflammatory cytokines, including IgE, tumor necrosis factor (TNF) -α, interleukin-1 (IL-1) and interleukin-6 (IL-6).Discussion: The results of this trial will provide evidence on the efficacy and safety of Longmu Tang granule and prove anti-inflammation of Longmu Tang granule for patients with AD.Trial registration: Chinese Clinical Trial Registry Chictr.org ID: ChiCTR2100041591. Registered on 1 January 2021. https://www.chictr.org.cn/showproj.aspx?proj=62586