Health TrialsbyHealthPanel

Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage

ConditionChronic Obstructive Pulmonary Disease
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age40-80
SponsorHenan University of Traditional Chinese Medicine

About this trial

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.

Eligibility criteria

This trial does not accept healthy volunteers

Qualifiers

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.

Disqualifiers

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 value.

Trial design

Design model

Parallel

Treatments tested in this trial

  • Bufei Yishen Prescription Granule

    Other intervention

    The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.

Treatment groups

848 Participants
are divided into 2 treatment groups
Group A: Bufei Yishen PrescriptionExperimental treatment 1 intervention
Group B: Bufei Yishen Prescription placeboPlacebo comparator 1 intervention

Trial outcomes

Primary outcomes

1

The number of acute exacerbations

The number of acute exacerbations

Time frame
Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.

Secondary outcomes

1

The number of AECOPD leading to hospitalization and death

Deaths due to AECOPD should be recorded in the study diary.

Time frame
Change from baseline the number of AECOPD leading to hospitalization and death at month 3, 6, 9 and 12.
2

Time of onset of the first AECOPD

the interval between the first medication and the first AECOPD (days).

Time frame
Immediately after the intervention
3

Severity of AECOPD

mild, moderate and severe

Time frame
Change from baseline severity of AECOPD at month 3, 6, 9and 12.
4

Duration of AECOPD

The duration of acute exacerbation is from the beginning of an acute exacerbation to the stabilization of the disease

Time frame
Change from baseline duration of AECOPD at month 3, 6, 9and 12.

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

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

Collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

Collaborator

Source ClinicalTrials.gov

This trial is not recruiting at the moment. You can still explore other options: