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

NCT03976713 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 348

Last updated 2019-06-06

No results posted yet for this study

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.

Conditions

Interventions

DRUG

Bufei Yishen granule

Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks.

DRUG

Placebo Bufei Yishen granule

Placebo Bufei Yishen granule will be administered twice daily for five days a week for 52 weeks. The placebo granule consists of dextrin, bitter and 5% of the Bufei Yishen granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group.

DRUG

Tiotropium Bromide Powder for Inhalation

Tiotropium Bromide Powder for Inhalation will be used once daily (18 μg each time) for 52 weeks.

Sponsors & Collaborators

  • ShuGuang Hospital

    collaborator OTHER

  • Henan University of Traditional Chinese Medicine

    lead OTHER

Principal Investigators

  • Jiansheng Li, Professor · The First Affiliated Hospital of Henan University of Traditional 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
2019-06-30
Primary Completion
2020-06-30
Completion
2020-12-31

Countries

  • China

Study Locations

More Related Trials

Entities

Diseases

Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT03976713 on ClinicalTrials.gov