Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 2:43 PM
Ignite Modification Date:
2025-12-24 @ 2:43 PM
NCT ID:
NCT07058259
Eligibility Criteria:
Inclusion Criteria:
* Volunteers aged between 40 and 80 years, who are communicative and cooperative,
* Diagnosed with COPD for at least 3 months,
* Receiving dual or triple regular pharmacological therapy for at least 3 months,
* Post-bronchodilator FEV1/FVC \<70% and predicted FEV1 \<80% on spirometry, mMRC (Modified Medical Research Council) dyspnea score of 2 or higher,
* COPD Assessment Test (CAT) score of 10 or higher.
Exclusion Criteria:
* Patients who do not consent to participate in the study,
* Patients with communication difficulties or with visual, walking, or hearing impairments,
* Patients currently experiencing a COPD exacerbation or with a history of exacerbation within the past month,
* Patients with Stage 1 COPD (FEV1 ≥ 80%),
* COPD patients receiving monotherapy,
* Patients with mMRC score \<2 and CAT score \<10,
* Patients with unstable angina, acute myocardial infarction (within 3-5 days), uncontrolled arrhythmia, active endocarditis, acute myocarditis/pericarditis, symptomatic severe aortic stenosis, lower extremity DVT, uncontrolled asthma/COPD, pulmonary edema, oxygen saturation (SpO₂) ≤ 90%, acute respiratory failure, or suspected dissecting aneurysm,
* Patients receiving long-term oxygen therapy (LTOT),
* COPD patients who have experienced more than two exacerbations in the past year.
Withdrawal Criteria:
* Patients who are unable to complete acupuncture sessions or follow-up assessments in the control group for any reason,
* Patients who experience an exacerbation during the study (they will be reassessed one month after recovery and may be re-included if eligible),
* Patients who miss more than two acupuncture sessions.
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
40 Years
Maximum Age:
80 Years
Study:
NCT07058259
Study Brief:
Protocol Section:
NCT07058259