Bufei Yishen Granule for Reducing Acute Exacerbation in GOLD Stage 3 or 4 COPD

• Status: Unknown status
• Trial end date: 2020-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to establish the treatment scheme of Bufei Yishen granule for GOLD stage 3 or 4 chronic obstructive pulmonary disease (COPD), reducing acute exacerbation, improving exercise capacity and forming high quality evidence.

• Phase: Phase 3
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Henan University of Traditional Chinese Medicine
• Collaborator: ShuGuang Hospital
• Treatments: Bromides; Tiotropium Bromide

Criteria

Inclusion Criteria:

• A confirmed diagnosis of GOLD stage 3 or 4 COPD.

• Syndrome differentiation meets criteria of Qi deficiency of the lung and spleen syndrome, Qi deficiency of the lung and kidney syndrome or Qi and Yin deficiency of the lung and kidney syndrome.

• Age ranges from 40 years to 80 years.

• With informed consent signed.

Exclusion Criteria:

• Pregnant and lactating women.

• Patients with severe cardiovascular and cerebrovascular diseases.

• Patients with severe liver and kidney diseases.

• Patients with asthma, bronchiectasis, active pulmonary tuberculosis, pulmonary embolism, chronic respiratory failure or other severe respiratory diseases.

• Patients with tumor after resection, radiotherapy or chemotherapy in the past 5 years.

• Patients with severe neuromuscular disorders, severe arthritis or severe peripheral vascular diseases.

• Patients with severe cognitive and psychiatric disorders.

• Patients with diabetes.

• Patients who were administered oral glucocorticoids in the past 4 weeks.

• Patients who have participated in other clinical studies in the past 4 weeks.

• People who are allergic to the treatment drugs.

• Patients who have experienced one or more acute exacerbation in the past 4 weeks.