Yiqi Huoxue Huatan Granule for Reducing Mortality in COPD With Chronic Respiratory Failure
NCT04208581 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 372
Last updated 2020-01-07
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.
Conditions
- Chronic Obstructive Pulmonary Disease
- Chronic Respiratory Failure
Interventions
- DRUG
-
Yiqi Huoxue Huatan granule
Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
- DRUG
-
Placebo Yiqi Huoxue Huatan granule
Placebo Yiqi Huoxue Huatan granule will be administered twice daily for five days a week for 52 weeks,Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks, Salmeterol / Fluticasone Powder for Inhalation will be used twice daily (50ug/250ug each time) for 52 weeks, Budesonide / Formoterol Powder for Inhalation will be used twice daily (320ug/4.5ug each time) for 52 weeks.
Sponsors & Collaborators
-
Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
collaborator OTHER -
Peking University People's Hospital
lead OTHER
Principal Investigators
-
Suyun Li, Doctor · The First Affiliated Hospital of Henan University of Chinese Medicine
Study Design
- Allocation
- RANDOMIZED
- Purpose
- TREATMENT
- Masking
- QUADRUPLE
- Model
- PARALLEL
Eligibility
- Min Age
- 40 Years
- Max Age
- 80 Years
- Sex
- ALL
- Healthy Volunteers
- No
Timeline & Regulatory
- Start
- 2019-10-08
- Primary Completion
- 2021-12-31
- Completion
- 2021-12-31
Countries
- China
Study Locations
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