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Bufei Jianpi Granule for Delaying Pulmonary Function Decline in Early-Stage COPD

NCT03976700 · Status: UNKNOWN · Phase: PHASE3 · Type: INTERVENTIONAL · Enrollment: 612

Last updated 2019-06-06

No results posted yet for this study

Summary

This study aims to establish the treatment scheme of Bufei Jianpi granule for early-stage (GOLD stage 1 or 2) chronic obstructive pulmonary disease (COPD), delaying pulmonary function decline and forming high quality evidence.

Conditions

Interventions

DRUG

Bufei Jianpi granule

Bufei Jianpi granule is composed of many kinds of traditional Chinese medicine. The granule will be administered twice daily for five days a week for 104 weeks.

DRUG

Placebo Bufei Jianpi granule

Placebo Bufei Jianpi granule consists of dextrin, bitter and 5% of the Bufei Jianpi granule. The appearance, weight, color and odor of the preparation are the same as those of treatment group. The placebo granule will be administered twice daily for five days a week for 104 weeks.

Sponsors & Collaborators

  • Jiangsu Province Hospital of Traditional Chinese Medicine

    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
2021-06-30
Completion
2021-12-31

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 NCT03976700 on ClinicalTrials.gov