Chronic Obstructive Pulmonary DiseaseNCT06326658
Bufei Yishen Prescription on Patients With Frequent AECOPD in Stable Stage
A study testing Bufei Yishen Prescription Granule in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine.
Trial 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. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Bufei Yishen Prescription Granule
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 848 participants
- Where
- No sites listed yet
- Study dates
- 1 Apr 2024to 31 Oct 2026
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
No sites are listed yet.
About this study
Official title: Evaluation of the Curative Effect and Health Economics of Bufei Yishen Prescription on Patients With Frequent Acute Exacerbation of COPD in Stable Stage
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.
Read the 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
- Being tested
- Bufei Yishen Prescription Granule
- Keywords
- Bufei Yishen Prescription, AECOPD, remission period, frequent
- Medical subject headings
- Pulmonary Disease, Chronic Obstructive
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bufei Yishen Prescription GranuleOther
The comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group.
| Study group | Role | What they receive |
|---|---|---|
| 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 Receives: 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. Receives: Other: Bufei Yishen Prescription Granule |
What is being measured
The primary outcome is the main question the study is designed to answer.
The number of acute exacerbations
The number of acute exacerbations
Measured: 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
Deaths due to AECOPD should be recorded in the study diary.
Measured: 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
the interval between the first medication and the first AECOPD (days).
Measured: Immediately after the intervention
Severity of AECOPD
mild, moderate and severe
Measured: Change from baseline severity of AECOPD at month 3, 6, 9and 12.
Duration of AECOPD
The duration of acute exacerbation is from the beginning of an acute exacerbation to the stabilization of the disease
Measured: Change from baseline duration of AECOPD at month 3, 6, 9and 12.
Case fatality rate
including the case fatality rate of AECOPD and the all-cause case fatality rate
Measured: Up to month 12
Lung function
FVC, FEV1, FEV1 % of the estimated value, FEV1/FVC were mainly used for evaluation
Measured: Change from baseline lung function at month 3, 6, 9and 12.
Score for clinical signs and symptoms
Formulate with reference to the "Guidelines for Clinical Research of New Chinese Medicines"Clinical scoring is weighted or assigned according to some of the main symptoms, signs, physiological parameters of patients, etc., so as to quantitatively evaluate the severity of the disease.The higher the score, the worse the state.
Measured: Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.
6-minute walking distance (6MWD)
The 6-minute walking test standard published by ERS and ATS was adopted
Measured: Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.
The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT)
The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT), with a score range of 0 to 40.The higher the score, the worse the state.
Measured: Change from baseline the chronic obstructive pulmonary patient self-assessment test (CAT) at month 3, 6, 9and 12.
The MOS item short fromhealth survey（SF-36）
SF-36 Includes 8 dimensions: physical functioning, physical functioning, somatic pain, general health status, social functioning, emotional functioning, and mental health.The higher the score, the worse the state.
Measured: Change from baseline SF-36 scale at month 3, 6, 9and 12.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Mar 2024
- Study start1 Apr 2024 (estimated)
- Primary completion1 May 2026 (estimated)
- Study completion31 Oct 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (1)Papers the sponsor has linked to this study.
- Other trials for Chronic Obstructive Pulmonary DiseaseStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 848 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06326658
- Sponsor's protocol ID
- TCM for Frequent AECOPD
- Status last verified
- Mar 2024
- First submitted
- 8 Mar 2024
- Last updated
- 22 Mar 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Publications
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.
PubMed 40969810
Study at a glance
From the registry record, last updated by the sponsor on 22 Mar 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Curative Effect and Health Economics of Bufei Yishen Prescription on Patients With Frequent Acute Exacerbation of COPD in Stable Stage
- ClinicalTrials.gov ID
- NCT06326658
- Acronym / sponsor ID
- TCM for Frequent AECOPD
- Conditions
- Chronic Obstructive Pulmonary Disease
- Keywords
- Bufei Yishen Prescription, AECOPD, remission period, frequent
- Study type
- Interventional
- Recruitment status
- Unknown status
- Enrolment
- 848 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- The First Affiliated Hospital of Henan University of Traditional Chinese Medicine, The First Affiliated Hospital of Anhui University of Traditional Chinese Medicine
- Study start
- 1 Apr 2024 (estimated)
- Primary completion
- 1 May 2026 (estimated)
- Study completion
- 31 Oct 2026 (estimated)
- First posted
- 22 Mar 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bufei Yishen Prescription | Experimental | Other: Bufei Yishen Prescription GranuleBufei 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 |
| Bufei Yishen Prescription placebo | Placebo comparator | Other: Bufei Yishen Prescription GranuleBufei 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. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (8 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Bufei Yishen Prescription GranuleThe comparison group was given Bufei Yishen Prescription Granule.The course of treatment was the same as that of the experimental group. | Other | Bufei Yishen Prescription, Bufei Yishen Prescription placebo |
Primary outcome
The number of acute exacerbations
Time frame: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.
The number of acute exacerbations
10 secondary outcomes
The number of AECOPD leading to hospitalization and death
Time frame: 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
Time frame: Immediately after the intervention
Severity of AECOPD
Time frame: Change from baseline severity of AECOPD at month 3, 6, 9and 12.
Duration of AECOPD
Time frame: Change from baseline duration of AECOPD at month 3, 6, 9and 12.
Case fatality rate
Time frame: Up to month 12
Lung function
Time frame: Change from baseline lung function at month 3, 6, 9and 12.
Score for clinical signs and symptoms
Time frame: Change from baseline clinical symptoms and signs at month 3, 6, 9and 12.
6-minute walking distance (6MWD)
Time frame: Change from baseline 6-minute walking distance (6MWD) at month 3, 6, 9and 12.
The Chronic Obstructive Pulmonary Patient Self-Assessment Test (CAT)
Time frame: Change from baseline the chronic obstructive pulmonary patient self-assessment test (CAT) at month 3, 6, 9and 12.
The MOS item short fromhealth survey（SF-36）
Time frame: Change from baseline SF-36 scale at month 3, 6, 9and 12.
Results and safety
Results are not available in the source record.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 22 Mar 2024.
- Derived from this study: PubMed 40969810Xiao 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.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Questions about this trial
What is this clinical trial studying?
A study testing Bufei Yishen Prescription Granule in people with Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 8 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: status not confirmed, as of the sponsor's last update on 22 Mar 2024. Status can change between updates, so confirm with the study contact before making plans.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
Results are not available in the source record.
How can a doctor refer a patient or contact the research team?
Contact Minghang Wang, MD (0371-66248624, wmh107hn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
The number of acute exacerbations (time frame: Change from baseline the number of acute exacerbations at month 3, 6, 9and 12.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT06326658, which also lists 1 linked publication.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 22 Mar 2024.