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Trials
Published in: Trials 1/2022

Open Access 01-12-2022 | Atopic Dermatitis | Study protocol

The efficacy and safety of Longmu Tang granule for the treatment of atopic dermatitis: study protocol for a single-centred, double-blinded, randomised, placebo-controlled trial

Authors: Ya-qin Li, Tao-tao Shen, Qing-ying Wang, Meng-xi Ma, Feng-yan Tian, Yuan-yao She, Yi-cheng Tao, Jing-jing Wang, Hui-yan Chi, Na Lang, Jian-xun Ren

Published in: Trials | Issue 1/2022

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Abstract

Background

Atopic dermatitis (AD) is a chronic relapsing skin disease that has long-term physical and mental health impacts on children with this condition. Current treatments mainly include anti-inflammatory, antibacterial, and anti-allergic interventions, systemic therapy, and recently emerging target-focused agents. However, these treatments have limited effectiveness and unwanted side effects. The use of traditional Chinese medicine (TCM) in the treatment of AD has a long history, with promising efficacies, low toxicity, and improvements in the quality of life of patients with AD. Longmu Tang granule, a TCM, has been used to effectively treat AD since 2008 through doctors’ prescriptions. To scientifically evaluate the clinical efficacy and safety of Longmu Tang granule, we proposed to launch a single-centred, double-blinded, randomised, placebo-controlled trial.

Methods

In this single-centred, double-blinded, randomised, placebo-controlled clinical trial conducted at Xiyuan Hospital of China Academy of Chinese Medical Sciences, a total of 60 participants will be randomly assigned (1:1) to receive the Longmu Tang granule or placebo granule for 8 weeks. The primary outcome will be evaluated using the index of Scoring Atopic Dermatitis. The secondary outcomes will be evaluated using the Children’s Dermatology Life Quality Index and the number cancellation test. The mechanistic evidence will be the serum levels of inflammatory cytokines, including immunoglobulin E, tumour necrosis factor-α, interleukin-1, and interleukin-6.

Discussion

The results of this trial will provide evidence of the efficacy and safety of the Longmu Tang granule and prove its anti-inflammatory action in patients with AD.

Trial registration

Chinese Clinical Trial Registry Chictr.​org ID: ChiCTR2100041591​. Registered on 1 January 2021
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Metadata
Title
The efficacy and safety of Longmu Tang granule for the treatment of atopic dermatitis: study protocol for a single-centred, double-blinded, randomised, placebo-controlled trial
Authors
Ya-qin Li
Tao-tao Shen
Qing-ying Wang
Meng-xi Ma
Feng-yan Tian
Yuan-yao She
Yi-cheng Tao
Jing-jing Wang
Hui-yan Chi
Na Lang
Jian-xun Ren
Publication date
01-12-2022
Publisher
BioMed Central
Published in
Trials / Issue 1/2022
Electronic ISSN: 1745-6215
DOI
https://doi.org/10.1186/s13063-022-06313-w

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