Efficacy of Adding Auricular Acupuncture to Xiao-Feng-San for Treating Atopic Dermatitis Exhibiting Wind-Dampness-Heat Manifestations According to Traditional Medicine: A Multi-Center, Double-Blinded, Randomized, Sham-Controlled Trial
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 发起方
- 入组人数
- 156
- 试验地点
- 4
- 主要终点
- Changes in Scoring Atopic Dermatitis (SCORAD) score
研究概览
简要总结
This study aims to compare the efficacy of adding auricular acupuncture to Xiao-Feng-San decoction versus Xiao-Feng-San decoction in treating atopic dermatitis. The trial is a multi-center, double-blinded, randomized, sham-controlled study.
详细描述
Atopic dermatitis (AD) is a chronic inflammatory skin condition that affects a significant number of individuals worldwide. In Traditional Medicine (TM), Xiao-Feng-San (XFS), a TM formula, has been widely used in the treatment of mild to moderate AD exhibiting wind-dampness-heat manifestations. This study aims to investigate whether the addition of auricular acupuncture (AA), a form of acupuncture targeting points on the ear, enhances the efficacy of XFS in treating AD.
The trial is a multi-center, double-blinded, randomized, sham-controlled study involving participants diagnosed with mild to moderate AD exhibiting wind-dampness-heat manifestations according to TM and indicated for the use of XFS decoction. Participants will be randomly assigned to receive either AA or sham AA (placebo) in addition to XFS. Outcome measures will include the severity of AD symptoms, quality of life assessments, the need for antipruritic medication, total serum immunoglobulin E (IgE) levels, and adverse effects.
Through rigorous methodology and blinding procedures, this study seeks to provide evidence on the comparative efficacy of adjunct AA in enhancing the therapeutic effects of XFS for AD. The findings aim to contribute valuable insights into optimizing treatment strategies for AD using integrative approaches.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Diagnosed with atopic dermatitis (AD) according to the American Academy of Dermatology guidelines and classified as mild to moderate.
- •Classified under Traditional Medicine as exhibiting wind-dampness-heat manifestations and prescribed Xiao-Feng-San decoction.
- •Voluntary informed consent.
排除标准
- •Presence of other active skin diseases or skin infections requiring systemic treatment within the past four weeks or that would interfere with the proper assessment of atopic dermatitis lesions.
- •Use of systemic therapy for AD, including but not limited to corticosteroids, methotrexate, cyclosporine, azathioprine, phosphodiesterase type 4 (PDE4) inhibitors, interferon-gamma (IFN-γ), and mycophenolate mofetil within the past four weeks.
- •Use of targeted biologic treatments within the past five half-lives (if known) or within the past 12 weeks, whichever is longer.
- •Use of phototherapy treatment, laser therapy, tanning booth sessions, or extended sun exposure that could affect disease severity or interfere with disease assessments within the past four weeks.
- •Use of systemic anti-infectives within the past four weeks.
- •Use of herbal medicine within the past 12 weeks.
- •Use of topical treatments for AD, including but not limited to topical corticosteroids (TCS), topical calcineurin inhibitors (TCIs), or topical phosphodiesterase-4 (PDE-4) inhibitors within the past one week.
- •History of alcohol or substance addiction within the past six months.
- •Prior experience with acupuncture.
- •Presence of existing injuries or lesions at the auricular acupoints under investigation in this study.
- •Concurrent participation in other clinical trials or use of other therapies for AD.
- •Pregnancy, lactation, or planning to become pregnant within approximately 12 weeks after the intervention.
- •Any history or current conditions that, in the investigator's assessment, would impede the participant's involvement in the study, the adherence to treatment, the evaluation of treatment efficacy, or pose risks to the participant during the study participation.
结局指标
主要结局
Changes in Scoring Atopic Dermatitis (SCORAD) score
时间窗: At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4)
The SCORAD index is a tool used to assess atopic dermatitis (AD) severity. It combines objective measures of lesion extent and intensity with subjective evaluations of symptoms like pruritus and sleep loss. Calculated using the formula: A/5 + 7B/2 + C, where A represents lesion extent (0-100 points), B rates six objective symptoms (0-18 points), and C measures subjective symptoms on a 10-cm scale (0-20 points), the total score ranges from 0 to 103 with higher scores indicating more severe AD.
次要结局
- Changes in Total Serum Immunoglobulin E (IgE) Levels(At randomization and after four weeks (Week 0, Week 4))
- Change in the Number of Antihistamine Tablets Used(Weekly throughout the four-week period (Week 1, Week 2, Week 3, Week 4))
- Proportion of intervention-related adverse effects (AEs)(Up to four weeks)
- Changes in Dermatology Life Quality Index (DLQI) Score(At randomization and weekly throughout the four-week period (Week 0, Week 1, Week 2, Week 3, Week 4))
研究者
An Hoa Tran, MD., MSc.
Principal Investigator
University of Medicine and Pharmacy at Ho Chi Minh City