Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure

• Status: Enrolling by invitation
• Trial end date: 2021-12-01
• Target enrollment: 0
• Participant gender: All

Summary

This study aims to establish the treatment scheme of Yiqi Huoxue Huatan granule for chronic obstructive pulmonary disease (COPD) with chronic respiratory failure (CRF), reducing mortality, improving quality of life and forming high quality evidence.

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

Details

• Lead Sponsor: Peking University People's Hospital
• Collaborator: The Affiliated Hospital of Liaoning University of TCM
• Treatments: Bromides; Budesonide; Budesonide, Formoterol Fumarate Drug Combination; Fluticasone; Formoterol Fumarate; Salmeterol Xinafoate; Tiotropium Bromide; Xhance

Criteria

Inclusion Criteria:

• A confirmed diagnosis of stable COPD;

• Arterial blood gas analysis meets criteria of PaO2 < 60mmHg and PaCO2 > 50mmHg during quiet breathing at sea level;

• Syndrome differentiation meets criteria of Qi deficiency, blood stasis and phlegm turbidity obstructing orifice syndrome；

• Age ranges from 40 years to 80 years;

• With informed consent signed.

Exclusion Criteria:

• • CRF resulting from other respiratory diseases, such as bronchiectasis, pulmonary cystic fibrosis, lung cancer, etc.;

• Acute exacerbation of CRF；

• Patients with severe cardiovascular and cerebrovascular diseases;

• Pregnant and lactating women;

• Patients with psychiatric disorders；

• Patients with diabetes;

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

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