Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage

NCT06326658 | Not Yet Recruiting DMC

• 1 other identifier: TCM for Frequent AECOPD
• Study Type: interventional
• Target: 848
• Locations: 0 countries
• Sites: N/A

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.

Conditions

Chronic Obstructive Pulmonary Disease

Keywords

Bufei Yishen Prescription; AECOPD; remission period; frequent

Outcome Measures

Primary Outcomes (1)

• The number of acute exacerbations

  The number of acute exacerbations

  Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.

Secondary Outcomes (10)

• The number of AECOPD leading to hospitalization and death

  Change from baseline the number of AECOPD leading to hospitalization and death at month 3, 6, 9 and 12.

• Time of onset of the first AECOPD

  Immediately after the intervention

• Severity of AECOPD

  Change from baseline severity of AECOPD at month 3, 6, 9and 12.

• Duration of AECOPD

  Change from baseline duration of AECOPD at month 3, 6, 9and 12.

• Case fatality rate

  Up to month 12

Study Arms (2)

Bufei Yishen Prescription

EXPERIMENTAL

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

Other: Bufei Yishen Prescription Granule

Bufei Yishen Prescription placebo

PLACEBO COMPARATOR

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.

Other: Bufei Yishen Prescription Granule

Interventions

Bufei Yishen Prescription Granule 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; Bufei Yishen Prescription placebo

Eligibility Criteria

• Age: 40 Years - 80 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.
• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Henan University of Traditional Chinese Medicine: lead
• The First Affiliated Hospital of Henan University of Traditional Chinese Medicine: collaborator
• The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine: collaborator

Related Publications (1)

• 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.

  PMID: 40969810 DERIVED

MeSH Terms

Conditions

Pulmonary Disease, Chronic Obstructive

Condition Hierarchy (Ancestors)

Lung Diseases, Obstructive; Lung Diseases; Respiratory Tract Diseases; Chronic Disease; Disease Attributes; Pathologic Processes; Pathological Conditions, Signs and Symptoms

Central Study Contacts

Minghang Wang, MD

CONTACT

0371-66248624; wmh107hn@163.com

Minghang Wang, MD

CONTACT

18638392188; wmh107hn@163.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 8, 2024
• First Posted: March 22, 2024
• Study Start: April 1, 2024
• Primary Completion: May 1, 2026
• Study Completion (Estimated): October 31, 2026
• Last Updated: March 22, 2024

Record last verified: 2024-03

Data Sharing

• IPD Sharing: Will not share