The Effects of Acupuncture on Patients With Chronic Asthma: a Multicenter, Randomized, Three-arm, Sham-controlled Superiority Trial
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 180
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Outcomes Assessor)
盲法说明
Masking is applied to participants and outcome assessors. Participants in the true acupuncture and sham acupuncture groups are blinded to group allocation, while participants in the usual-care group are unblinded. Outcome assessors remain blinded throughout the trial. Acupuncturists and clinical care providers are unblinded due to the nature of acupuncture intervention.
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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.
排除标准
- •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.
研究者
Lei-Miao Yin
Research Fellow
Shanghai Municipal Hospital of Traditional Chinese Medicine