Study on Acupuncture Treatment of Chronic Airway Diseases(Asthma and Chronic Obstructive Pulmonary Disease)

Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-80
SponsorHenan University of Traditional Chinese Medicine

About this trial

For patients in the acute phase of chronic airway diseases, on the basis of guideline-directed treatment, the experimental group was given acupuncture treatment, while the control group was given sham acupuncture treatment. The treatment lasted for one week, followed by a 13-week follow-up. For asthma and COPD, PEF and CAT were respectively used as the primary outcome measures to evaluate the clinical efficacy and safety of acupuncture. Based on the improvement of the primary outcome measures, the advantageous population was identified. The mechanism by which acupuncture reduces airway mucus hypersecretion was preliminarily explained.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

Meets the diagnostic criteria for acute attack of asthma/AECOPD;

Age range from18 years to 80 years(asthma) and 40 yesrs to 80 years(COPD);

The investigators agreed to participate in this clinical study by voluntarily signing an informed consent form.

Disqualifiers

Patients with combined pulmonary abscess, pulmonary interstitial fibrosis, active pulmonary tuberculosis, bronchiectasis and other pulmonary diseases;

Patients with severe cardiovascular and cerebrovascular diseases (such as malignant arrhythmia, unstable angina pectoris, acute myocardial infarction, grade 3 or above cardiac function, stroke, cerebral hemorrhage, etc.);

Patients with severe liver diseases (such as liver cirrhosis, portal hypertension and bleeding caused by esophageal and gastric fundus varices) and severe kidney diseases (such as dialysis, kidney transplantation, etc.);

Patients with impaired consciousness or various mental disorders who are unable to communicate normally;

Trial design

Design model

Parallel

Treatments tested in this trial

  • Acupuncture

    Behavioral

    Dingchuan, Shanzhong, Tiantu, Feishu, Kongji, after obtaining qi, connect the electric needle (continuous wave, The frequency was 2Hz, the current intensity was 1\~5mA, and the current intensity was gradually increased according to patient tolerance), and the treatment was 30min.

  • Sham Acupuncture

    Behavioral

    Dingchuan, Shanzhong, Tiantu, Feishu, hole the most points open 5\~10mm, shallow piercing through the skin, connected with the electric needle but no electricity, treatment 30min.

Treatment groups

576 Participants
are divided into 2 treatment groups
Group A: Acupuncture group for Asthma Acute/AECOPDExperimental treatment 1 intervention
Group B: Sham Acupuncture group for Asthma Acute/AECOPDSham comparator 1 intervention

Trial outcomes

Primary outcomes

1

Astham part: PEF

Record the peak expiratory flow rate(PEF) for each patient, and evaluate the impact of acupuncture on improving the peak expiratory flow (PEF) of asthma patients.

Time frame
Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
2

COPD part:CTA

Record the COPD Assessment Test (CAT) for each patient, and evaluate the impact of acupuncture on improving the clinical symptoms of patients with AECOPD.

Time frame
Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

Secondary outcomes

1

Astham part: the Asthma Control Test (ACT)

ACT includes five questions. Every question will be assessed using a 5-point scale with scores ranging from 5 to 25. The higher the score, the better the symptom control.25 is considered complete control level, 20 \~ 24 is considered good control level, and \<20 is considered non-control level.

Time frame
Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
2

Asthma part:Asthma Control Questionnaire(ACQ)

The content of ACQ involves the following aspects: asthma-related, symptoms, the use of first-aid drugs, the impact on daily life and lung function test results.The higher the score, the worse the state.

Time frame
Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
3

Asthma part:Asthma Quality of Life Questionnaire(AQLQ)

The asthma quality of life scale (5-point scale-RRB- consists of 35 items, including activity limitation (1-12) , asthma symptoms (13-20) , psychological status (22-26) , response to stimuli (27-31) , concern for one's own health (32-35) . On a 5-point scale, 1 is the worst and 5 is the best.

Time frame
Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up
4

Asthma part:The cough and expectoration assessment questionnaire (CASA-Q)

Each indicator of the patient is scored from 1 to 5 based on the severity. After reverse scoring, the lower the score, the more severe the airway mucus hypersecretion and the poorer the therapeutic effect.

Time frame
Before treatment, at 4 and 7 days of treatment, and at 4 and 13 weeks of follow-up

Other outcomes

Locations

This trial has no locations.

Sponsors and contacts

Click on the lead sponsor to view all of their trials.

Henan University of Traditional Chinese Medicine

Lead sponsor

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Collaborator

Hebei Provincial Hospital of Traditional Chinese Medicine

Collaborator

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