Efficacy of Acupuncture in the Treatment of Moderate-to-severe Atopic Dermatitis: a Multicentre Randomised Sham-controlled Clinical Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 110
- 主要终点
- SCORing atopic dermatitis（SCORAD）
研究概览
简要总结
This study used a multicentre parallel three-armed randomised sham-controlled clinical trial methodology in order to objectively and normatively assess the efficacy of acupuncture on Quchi the Sea of Blood the Foot Sanli and the Sanyinjiao in the treatment of moderate-to-severe atopic dermatitis so as to obtain high-level evidence-based medical evidence.
This study adopts a multi-centre, parallel, three-armed, randomized, sham-controlled clinical trial method, and will be conducted at Yueyang Hospital of Integrative Medicine affiliated with Shanghai University of Traditional Chinese Medicine, Huashan Hospital affiliated with Fudan University, and Seventh People's Hospital affiliated with Shanghai University of Traditional Chinese Medicine. Eligible patients with moderate-to-severe AD will be divided into three groups using stratified block randomisation in the ratio of 2:2:1: the acupuncture group, the sham-acupuncture group and the waitlisted control group. The total observation period is 9 weeks, including a 1-week introduction period, a 4-week treatment period and a 4-week follow-up period.
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 75 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Meet the diagnostic criteria for moderate to severe atopic dermatitis;
- •Age ≥18 and ≤75 years old gender is not limited; ③ Peak Pruritus Numerical Rating Scale (PP-NRS) score ≥4; ④ Voluntarily participate in this trial and sign the informed consent form.
排除标准
- •Patients who are in the acute onset of the disease and have erosions exudates and secondary infections;
- •Patients who have participated in other clinical studies in the past 3 months or are participating in other clinical studies; ③ Patients with severe haematological diseases (e.g. platelet count <50×109 /L) and other serious diseases that may affect operation and efficacy;
- •Current systematic use of glucocorticosteroids discontinued for less than 7 days; immunosuppressants (cyclosporine methotrexate tretinoin etc.) discontinued for less than 1 month; dulprevirizumab discontinued for less than 1 month JAK inhibitors discontinued for less than 2 weeks;
- •Women who are pregnant or breastfeeding; ⑥ Patients with a history of acupuncture treatment.
结局指标
主要结局
SCORing atopic dermatitis（SCORAD）
时间窗: This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).
SCORAD range of 0 \~ 103 points.The condition is classified as mild, moderate or severe according to the score, with the higher the score, the more severe the condition.
次要结局
- Serum total IgE(This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).)
- Patient Oriented Eczema Measure (POEM)(This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).)
- Dermatology Life Quality Index（DLQI）(This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).)
- Peak Pruritus Numerical Rating Scale（PP-NRS）(This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9), and day 56 ± 3 (V10).)
- Skin Peripheral sympathetic nerve activity (SKNA)(This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).)
- Peripheral blood serum cytokines（IL-4,IL-13,IL-31,IL-33,INF-α）(This indicator will be measured at baseline day 1 (V2), day 27 ± 1 (V9).)