Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage (NCT06326658) | Clinical Trial Compass
Not Yet RecruitingNot Applicable
Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage
848 participantsStarted 2024-04-01
Plain-language summary
To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase.
Who can participate
Age range40 Years – 80 Years
SexALL
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AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
Inclusion Criteria:
* Patients diagnosed with COPD at a stable stage.
* Stable COPD patients with frequent acute exacerbation.
* Age 40-80 years old.
* The condition was stable 4 weeks before enrollment.
* 5 did not participate in other drug clinical studies within 1 month before enrollment.
* At least 3 months of maintenance therapy with triple inhalation preparation was used before enrollment.
* Washout period was 2 weeks before enrollment.
* Voluntarily receive treatment and sign informed consent.
Exclusion Criteria:
* complicity with other diagnosed and clinically significant respiratory diseases, including but not limited to: asthma, active pulmonary tuberculosis, bronchiectasis, pulmonary hypertension, pulmonary embolism, pneumothorax, pleural effusion, interstitial lung disease, or other active pulmonary diseases requiring intervention.
* Patients with severe or acute cardiovascular and cerebrovascular diseases (acute cardiovascular and cerebrovascular events, malignant arrhythmias, unstable angina pectoris, cardiac function grade 3 or above, uncontrolled hypertension, etc.).
* Complicated with severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, serious kidney disease including dialysis, kidney transplantation).
* Any item of liver function index (ALT, AST) exceeds the upper limit of normal reference value by 1.5 times, and renal function index Scr exceeds the upper limit of normal reference valu…
What they're measuring
1
The number of acute exacerbations
Timeframe: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.
Trial details
NCT IDNCT06326658
SponsorHenan University of Traditional Chinese Medicine