A Study of Acupuncture for Treating Asthma
2026年5月28日 更新者：Lei-Miao Yin、Shanghai University of Traditional Chinese Medicine
The Effects of Acupuncture on Patients With Chronic Asthma: a Multicenter, Randomized, Three-arm, Sham-controlled Superiority Trial
Asthma is a common chronic respiratory disease with a low clinical control rate, highlighting the need for novel therapeutic strategies.
Recurrent asthma attacks emotional symptoms, such as anxiety and depression, etc.
On the contrary, symptoms such as anxiety and depression worsen asthma control.
Acupuncture is commonly applied as an effective traditional Chinese medical therapy for asthma.
Acupoints GV14, BL13 and BL12 are adopted for the intervention of asthma.
GV20 and GV29 are selected to improve emotional symptoms including depression.
Nevertheless, standardized therapeutic regimens of acupuncture for asthma and its concomitant emotional symptoms are still lacking.
180 patients with mild to moderate asthma will be recruited in this multicenter randomized controlled trial, randomly assigned to the true acupuncture group, sham acupuncture group and usual care group.
The primary outcome is the score of the Asthma Control Test (ACT).
Secondary outcomes include the Hospital Anxiety and Depression Scale (HADS), Asthma Quality of Life Questionnaire (AQLQ), pulmonary function, and fractional exhaled nitric oxide (FeNO).
The superiority of combined acupuncture therapy in improving asthma control, relieving negative emotions, and enhancing quality of life is to be verified in this study, with high quality evidence for acupuncture treatment of asthma thereby to be provided.
研究概览
研究类型
介入性
注册 (估计的)
180
阶段
- 不适用
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Lei-Miao Yin, MD
- 电话号码：+86 21 56639828
- 邮箱：collegeylm@shutcm.edu.cn
研究联系人备份
- 姓名：Xin Luan, MD
- 电话号码：+86 17701614380
- 邮箱：lx931163088@163.com
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
不
描述
Inclusion Criteria:
- Meet the diagnostic criteria for asthma, and be in the chronic persistent phase with mild to moderate disease severity, referring to the grading criteria of the Guidelines for the Prevention and Treatment of Asthma (2024 Edition).
- Aged 18 to 70 years, regardless of gender.
- Asthma Control Test (ACT) score≤19 points (poorly controlled or very poorly controlled asthma).
- Maintain a stable asthma treatment regimen for at least 4 weeks before enrollment.
- Clear thinking and consciousness, coherent responses, able to understand the items of various scales and complete the assessment.
- Volunteer to participate in this study and sign a written informed consent form.
Exclusion Criteria:
- Complicated with severe mental illnesses (such as uncontrolled schizophrenia, acute phase of bipolar disorder, etc.) or moderate to severe cognitive impairment (such as dementia), resulting in inability to understand the research process or cooperate with efficacy evaluation.
- A history of substance/alcohol dependence within the past 12 months.
- Complicated with other physical diseases that may cause depressive symptoms (such as hypothyroidism, chronic pain syndrome, malignant tumors, rheumatoid arthritis, etc.).
- Received antidepressant drug treatment within the past 6 months.
- Suffering from other respiratory diseases, such as chronic obstructive pulmonary disease (COPD), bronchiectasis, pulmonary fibrosis, etc.
- Complicated with other cancers or relatively severe chronic diseases of the heart, liver, kidneys, etc.
- Received acupuncture treatment within the past 3 months.
- Pregnant or lactating women.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：双倍的
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：True Acupuncture Group
Acupuncture Group: On routine standard asthma treatment, participants receive acupuncture.
Disposable sterile needles (Wuxi Jiajian Medical Instrument Co., Ltd.) are used: 0.25 mm×25 mm for Baihui (GV20), Yintang (GV29); 0.30 mm×40 mm for Dazhui (GV14), bilateral Fengmen (BL12) and Feishu (BL13).Qualified acupuncturists perform treatment following GB/T 12346-2021.
Patients sit with routine skin disinfection.
Baihui: 15-30° oblique insertion, 0.5 cun.
Yintang: downward oblique puncture 0.3-0.5 cun with skin pinched.
Dazhui: perpendicular 0.5-1 cun.
Fengmen and Feishu: perpendicular toward spine, 0.5-0.8
cun.
Even reinforcing-reducing manipulation is applied.
Each session lasts 30 minutes, 3 times weekly for 10 sessions.
Eye masks are used; operators are separated from outcome assessors.
|
Patients are seated with routine disinfection of acupoints.
Dazhui (GV14) is perpendicularly needled 0.5-1 cun; Feishu (BL13) and Fengmen (BL12) are perpendicularly needled toward the spine for 0.5-0.8
cun; Baihui (GV20) is needled subcutaneously at 15-30° to the scalp for 0.5 cun; Yintang (GV29) is obliquely needled downward for 0.3-0.5 cun after pinching local skin .
Even reinforcing-reducing manipulation is adopted.
Each treatment lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions.
Eye masks are used, with separation of operators and outcome assessors.
|
|
假比较器：Sham Acupuncture Group
Sham Acupuncture Group: On the basis of routine standard asthma treatment, participants receive Streitberger placebo needle intervention.
The Streitberger placebo needle (Asiamed GmbH, Germany) is a non-penetrating sham acupuncture device with identical appearance to real needles but a blunt tip.
Upon gentle skin contact, the shaft retracts into the handle, secured by an external patch to simulate needle insertion visually.
The same acupoints are used as in the acupuncture group: GV14, BL13, BL12, GV20 and GV29.Participants sit with routine skin disinfection.
The placebo needle base pad is fixed on acupoints.
Vertical pressure on the handle retracts the shaft without skin penetration.
Each session lasts 30 minutes, 3 times weekly for 10 consecutive sessions.
Needles are removed directly without hemostasis.
Eye masks are used during treatment; operators are separated from outcome assessors.
|
Patients are seated with routine disinfection of acupoints.
Streitberger non-penetrating placebo needles are applied to the same acupoints as true acupuncture (Dazhui GV14, Feishu BL13, Fengmen BL12, Baihui GV20, Yintang GV29) with identical position, duration and frequency.
Each sham session lasts 30 minutes, three times weekly (no treatment on Sundays) for 10 consecutive sessions.
Eye masks are used, with separation of operators and outcome assessors.
|
|
有源比较器：Usual Care Group
Participants receive only standard pharmacological treatment for asthma in accordance with clinical guidelines, without any acupuncture or related interventions.
|
Patients receive routine asthma pharmacological treatment without additional acupuncture intervention.
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Asthma Control Test (ACT)
大体时间：Change from baseline to week 4 (end of treatment)
|
The Asthma Control Test (ACT) is a validated 5-item self-reported questionnaire assessing overall asthma control, with total scores ranging from 5 to 25.
Higher scores indicate better asthma control.
|
Change from baseline to week 4 (end of treatment)
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Hospital Anxiety and Depression Scale (HADS)
大体时间：Change from baseline to week 4 (end of treatment)
|
A validated self-rating scale containing anxiety (HADS-A) and depression (HADS-D) subscales, each with 7 items.
Lower scores indicate less anxiety and depressive symptoms.
|
Change from baseline to week 4 (end of treatment)
|
|
Asthma-Specific Quality of Life Questionnaire (AQLQ)
大体时间：Change from baseline to week 4 (end of treatment)
|
A validated self-reported questionnaire evaluating asthma-related quality of life, covering symptoms, activity limitation, emotional function and environmental stimuli.
Higher scores represent better quality of life.
|
Change from baseline to week 4 (end of treatment)
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
合作者
调查人员
- 研究主任：Lei-Miao Yin, MD、Shanghai Municipal Hospital of Traditional Chinese Medicine
- 学习椅：Ping Yin, MD、Longhua Hospital
- 学习椅：Xin-Yun Huang, MD、Yueyang Hospital, Shanghai University of Traditional Chinese medicine
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月21日
初级完成 (估计的)
2028年3月1日
研究完成 (估计的)
2028年9月1日
研究注册日期
首次提交
2026年5月21日
首先提交符合 QC 标准的
2026年5月21日
首次发布 (实际的)
2026年5月28日
研究记录更新
最后更新发布 (实际的)
2026年6月1日
上次提交的符合 QC 标准的更新
2026年5月28日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
其他相关的 MeSH 术语
其他研究编号
- 2026SHL-KY-68-01
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
IPD 计划说明
Individual participant data will not be shared due to participant privacy protection and limited research resources
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
不
此信息直接从 clinicaltrials.gov 网站检索，没有任何更改。如果您有任何更改、删除或更新研究详细信息的请求，请联系 register@clinicaltrials.gov. clinicaltrials.gov 上实施更改，我们的网站上也会自动更新.