Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage

NCT ID: NCT06326658

Last Updated: 2024-03-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 848 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-04-01
• Study Completion Date: 2026-10-31

Brief Summary

To evaluate the clinical efficacy and health economic advantages of Lung Replenishing and Kidney Enhancing Formula for the treatment of patients with frequent acute exacerbations in the stabilized phase.

Detailed Description

This study is based on a real world using a multicenter, randomized, double-blind, placebo-controlled trial.Based on a real-world multi-center, randomized, double-blind, placebo-controlled trial, this study will clinically observe patients with frequent acute exacerbations of chronic obstructive pulmonary disease in the stable phase.The study will evaluate the clinical efficacy and safety of Chinese medicine treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization and application of Chinese medicine therapy in chronic obstructive pulmonary disease.This study will scientifically evaluate the clinical efficacy and safety of TCM treatment programs in patients with frequent acute exacerbations of stable chronic obstructive pulmonary disease, and provide high-quality evidence for the popularization of TCM evidence-based treatment in chronic obstructive pulmonary disease.

Conditions

Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

Bufei Yishen Prescription

Bufei Yishen formula consists of Radix Panax Ginseng 6g, Radix Astragali 15g, Cornu Cervi Pantotrichum 12g, Fructus Lycii 12g, Fructus Schisandrae Chinensis 9g, Fructus Epimedium Brevicornum 9g, Fructus Pelargonium Chinense 9g, Radix Paeoniae Lactiflorae 9g, Rhizoma Dillonis 9g, Fructus Ziziphiroxylon 9g, Fructus Schisandrae Chinense 15g, Pericarpium Citriodora 9g

Group Type: EXPERIMENTAL

Bufei Yishen Prescription Granule

Intervention Type: OTHER

The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.

Bufei Yishen Prescription placebo

Bufei Yishen Prescription placebo is prepared by adding 5% of the drug on the basis of dextrin and bitter agent, and its appearance, weight, color and smell are consistent with Chinese medicine granules.

Group Type: PLACEBO_COMPARATOR

Bufei Yishen Prescription Granule

Intervention Type: OTHER

The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.

Interventions

Bufei Yishen Prescription Granule

The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.

Intervention Type: OTHER

Eligibility Criteria

Inclusion Criteria

• Patients diagnosed with COPD at a stable stage.
• Stable COPD patients with frequent acute exacerbation.
• Age 40-80 years old.
• The condition was stable 4 weeks before enrollment.
• 5 did not participate in other drug clinical studies within 1 month before enrollment.
• At least 3 months of maintenance therapy with triple inhalation preparation was used before enrollment.
• Washout period was 2 weeks before enrollment.
• Voluntarily receive treatment and sign informed consent.

Exclusion Criteria

• complicity with other diagnosed and clinically significant respiratory diseases, including but not limited to: asthma, active pulmonary tuberculosis, bronchiectasis, pulmonary hypertension, pulmonary embolism, pneumothorax, pleural effusion, interstitial lung disease, or other active pulmonary diseases requiring intervention.
• Patients with severe or acute cardiovascular and cerebrovascular diseases (acute cardiovascular and cerebrovascular events, malignant arrhythmias, unstable angina pectoris, cardiac function grade 3 or above, uncontrolled hypertension, etc.).
• Complicated with severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, serious kidney disease including dialysis, kidney transplantation).
• Any item of liver function index (ALT, AST) exceeds the upper limit of normal reference value by 1.5 times, and renal function index Scr exceeds the upper limit of normal reference value.
• Tumor patients who have undergone surgical resection, radiotherapy and chemotherapy in the past five years.
• Patients with mobility difficulties caused by severe osteoarthropathy, neuromuscular disease, and peripheral vascular disease.
• Combined with absolute or relative prohibition of 6-minute walking test: such as resting heart rate > 120 beats/min, systolic blood pressure > 180mmHg or diastolic blood pressure > 100mmHg; Or have limited activity to complete the 6-minute walking test.
• Combined with cognitive or mental disorders.
• Glucocorticoids were taken orally within 2 weeks before enrollment.
• Had taken any Chinese medicine preparations (decoction, formula granule, proprietary Chinese medicine, etc.) prohibited during the study period according to the protocol within 2 weeks before enrollment.
• People who are known to be allergic to therapeutic drugs.
• Pregnant and lactating women, people who plan to become pregnant or cannot use effective contraceptive measures.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

The First Affiliated Hospital of Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Minghang Wang, MD

Role: CONTACT

wmh107hn@163.com

0371-66248624

Minghang Wang, MD

Role: CONTACT

wmh107hn@163.com

18638392188

References

Xiao Q, Wang M, Li Z, Chen T, Li J. Efficacy and health economics of Bufei Yishen granules in patients with frequent exacerbator phenotype in the stable phase of chronic obstructive pulmonary disease: study protocol for a multicenter, randomized, double-blind, placebo-controlled trial. Front Med (Lausanne). 2025 Sep 3;12:1662655. doi: 10.3389/fmed.2025.1662655. eCollection 2025.

Reference Type: DERIVED

PMID: 40969810 (View on PubMed)

Other Identifiers

TCM for Frequent AECOPD

Identifier Type: -

Identifier Source: org_study_id