Bufei Recipe Reduces the Incidence Rate of COPD

April 16, 2024 updated by: Henan University of Traditional Chinese Medicine

Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study

Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.

Study Overview

Status

Status

Indicates the current recruitment status or the expanded access status.
Not yet recruiting

Conditions

Conditions

The disease, disorder, syndrome, illness, or injury that is being studied. On ClinicalTrials.gov, conditions may also include other health-related issues, such as lifespan, quality of life, and health risks.

Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.

Detailed Description

Taking PRISM patients with impaired lung function at the early stage of COPD retention ratio as the research object, and aiming at the key problems such as the lack of prevention and treatment plan, a two-year randomized double-blind placebo controlled clinical study of Bufei Fang was carried out to establish the early stage TCM prevention and treatment plan to reduce the incidence rate of COPD.

Study Type

Study Type

Describes the nature of a clinical study. Study types include interventional studies (also called clinical trials), observational studies (including patient registries), and expanded access.
Interventional

Enrollment (Estimated)

Enrollment

The number of participants in a clinical study. The "anticipated" enrollment is the target number of participants that the researchers need for the study.
1100

Phase

Phase

The stage of a clinical trial studying a drug or biological product, based on definitions developed by the U.S. Food and Drug Administration (FDA). The phase is based on the study's objective, the number of participants, and other characteristics. There are five phases: Early Phase 1 (formerly listed as Phase 0), Phase 1, Phase 2, Phase 3, and Phase 4. Not Applicable is used to describe trials without FDA-defined phases, including trials of devices or behavioral interventions.
  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Contact

Study Contact

The name and contact information for the person who can answer enrollment questions for a clinical study. Each location where the study is being conducted may also have a specific contact, who may be better able to answer those questions.

Study Contact Backup

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Eligibility Criteria

The key requirements that people who want to participate in a clinical study must meet or the characteristics they must have. Eligibility criteria consist of both inclusion criteria (which are required for a person to participate in the study) and exclusion criteria (which prevent a person from participating). Types of eligibility criteria include whether a study accepts healthy volunteers, has age or age group requirements, or is limited by sex.

Ages Eligible for Study

  • Adult
  • Older Adult

Accepts Healthy Volunteers

No

Description

Inclusion Criteria:

  1. Risk factors for chronic obstructive pulmonary disease. Having one item from a, b, and c (risk factors will be further optimized based on the screening results of high-risk populations):

    1. smoking history (including previous and current smokers);
    2. 1 year or more of exposure to dust or chemical toxins;
    3. Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.

  2. Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:

    1. Cough (more than 3 months per year, continuous for 2 years or more);
    2. Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
    3. Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
  3. The lung function test meets the following criteria: forced expiratory volume in one second (FEV1)/forced vital capacity (FVC) ≥ 70% and FEV1 accounting for%<80% of the expected value.
  4. Meets the diagnostic criteria for lung qi deficiency syndrome.
  5. Age range from 18 to 80 years old.
  6. Voluntarily participate in the study and sign an informed consent form.

Exclusion Criteria:

  • Pregnant and planned pregnancy, lactating women.
  • Dementia and various mental illness patients.
  • Other diseases with chronic cough, sputum production, or difficulty breathing.
  • Merge tumors.
  • Merge severe cardiovascular and cerebrovascular diseases.
  • Concomitant severe liver and kidney diseases.
  • Participants in clinical trials of other drugs.
  • Allergies to intervention drugs.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm

Participant Group / Arm

A group or subgroup of participants in a clinical trial that receives a specific intervention/treatment, or no intervention, according to the trial's protocol.
Intervention / Treatment

Intervention / Treatment

A process or action that is the focus of a clinical study. Interventions include drugs, medical devices, procedures, vaccines, and other products that are either investigational or already available. Interventions can also include noninvasive approaches, such as education or modifying diet and exercise.
Experimental: Bufei Recipe
Bu Fei Fang: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.
Drug: Bufei Recipe
Bufei Recipe: Roasted Astragalus, Codonopsis pilosula, Walnut kernels, Sichuan Fritillaria, Angelica sinensis, Stir fried Purple Su Zi, Honey Baibu, Roasted Purple Aster, etc. Take 1 dose daily, 5 days a week.
Placebo Comparator: Bufei Recipe placebo
The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.
Drug: Bufei Recipe placebo
The placebo was prepared using 5% of the drug, with color, odor, taste, appearance, and weight similar to the experimental group drug, and packaging consistent with the experimental group drug.

What is the study measuring?

Primary Outcome Measures

Primary Outcome Measures

In a clinical study's protocol, the planned outcome measure that is the most important for evaluating the effect of an intervention/treatment. Most clinical studies have one primary outcome measure, but some have more than one.
Outcome Measure
Measure Description
Time Frame
Incidence rate of COPD
Time Frame: Change from baseline in the number of people with COPD at month 24.
Incidence rate of COPD
Change from baseline in the number of people with COPD at month 24.

Secondary Outcome Measures

Secondary Outcome Measures

In a clinical study's protocol, a planned outcome measure that is not as important as the primary outcome measure for evaluating the effect of an intervention but is still of interest. Most clinical studies have more than one secondary outcome measure.
Outcome Measure
Measure Description
Time Frame
FVC
Time Frame: Change from baseline in FVC at months 12 and 24.
Forced Vital Capacity (FVC) was mainly used for lung function evaluation
Change from baseline in FVC at months 12 and 24.
FEV1
Time Frame: Change from baseline in FEV1 at months 12 and 24.
Forced Expiratory Volume in One Second (FEV1) was mainly used for lung function evaluation
Change from baseline in FEV1 at months 12 and 24.
FEV1% pred
Time Frame: Change from baseline in FEV1% pred at months 12 and 24.
Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) was mainly used for lung function evaluation
Change from baseline in FEV1% pred at months 12 and 24.
FEV1/FVC
Time Frame: Change from baseline in FEV1/FVC at months 12 and 24.
Forced Expiratory Volume in One Second / Forced Vital Capacity (FEV1/FVC) was mainly used for lung function evaluation
Change from baseline in FEV1/FVC at months 12 and 24.
IPAG-Q
Time Frame: Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.
International Primary Airway Health Organization Questionnaire (IPAG-Q) was mainly used for chronic obstructive pulmonary screening score evaluation.
Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.
LFQ
Time Frame: Change from baseline in LFQ score at months 6, 12, 18, and 24.
Lung Function Questionnaire (LFQ) was mainly used for chronic obstructive pulmonary screening score evaluation.
Change from baseline in LFQ score at months 6, 12, 18, and 24.
COPD-PS
Time Frame: Change from baseline in COPD-PS score at months 6, 12, 18, and 24.
Chronic Obstructive Pulmonary Disease Population Screening Questionnaire (COPD-PS) was mainly used for chronic obstructive pulmonary screening score evaluation.
Change from baseline in COPD-PS score at months 6, 12, 18, and 24.
CAT
Time Frame: Change from baseline in CAT score at months 6, 12, 18, and 24.
Chronic Obstructive Pulmonary Disease Assessment (CAT) was mainly used for quality of life evaluation.
Change from baseline in CAT score at months 6, 12, 18, and 24.
SF-36
Time Frame: Change from baseline in SF-36 score at months 6, 12, 18, and 24.
Health Survey Brief (SF-36) was mainly used for quality of life evaluation.
Change from baseline in SF-36 score at months 6, 12, 18, and 24.
Clinical symptoms
Time Frame: Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.
The assessment will be done through a clinical symptom assessment questionnaire. Clinical symptoms assessed in this study include cough, sputum, wheezing, chest tightness, shortness of breath, malaise and cyanosis. Each symptom or sign will receive a score of 0-3, with higher scores indicating greater severity of the condition.
Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.
Biochemical indicators
Time Frame: Change from baseline in biochemical indicators at month 12 and 24.
Serum levels of TNF- α, IL-1, IL-6, immunoglobulin and renal connexin, prolyl peptidase, heme oxygenase-1, superoxide dismutase, glutathione peroxidase and angiotensin-converting enzyme were measured. All indicators were measured in ng/ml.
Change from baseline in biochemical indicators at month 12 and 24.

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Sponsor

The organization or person who initiates the study and who has authority and control over the study.
Henan University of Traditional Chinese Medicine

Collaborators

Collaborators

An organization other than the sponsor that provides support for a clinical study. This support may include activities related to funding, design, implementation, data analysis, or reporting.
West China Hospital
The First Affiliated Hospital of Zhejiang Chinese Medical University

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start (Estimated)

Study Start

The actual date on which the first participant was enrolled in a clinical study. The "anticipated" study start date is the date that the researchers think will be the study start date.
May 1, 2024

Primary Completion (Estimated)

Primary Completion

The date on which the last participant in a clinical study was examined or received an intervention to collect final data for the primary outcome measure. Whether the clinical study ended according to the protocol or was terminated does not affect this date. For clinical studies with more than one primary outcome measure with different completion dates, this term refers to the date on which data collection is completed for all the primary outcome measures. The "anticipated" primary completion date is the date that the researchers think will be the primary completion date for the study.
April 30, 2027

Study Completion (Estimated)

Study Completion

The date on which the last participant in a clinical study was examined or received an intervention/treatment to collect final data for the primary outcome measures, secondary outcome measures, and adverse events (that is, the last participant's last visit). The "anticipated" study completion date is the date that the researchers think will be the study completion date.
October 31, 2027

Study Registration Dates

First Submitted

First Submitted

The date on which the study sponsor or investigator first submitted a study record to ClinicalTrials.gov. There is typically a delay of a few days between the first submitted date and the record's availability on ClinicalTrials.gov (the first posted date).
April 2, 2024

First Submitted That Met QC Criteria

First Submitted That Met QC Criteria

The date on which the study sponsor or investigator first submits a study record that is consistent with National Library of Medicine (NLM) quality control (QC) review criteria. The sponsor or investigator may need to revise and submit a study record one or more times before NLM's QC review criteria are met. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

First Posted (Actual)

First Posted

The date on which the study record was first available on ClinicalTrials.gov after National Library of Medicine (NLM) quality control (QC) review has concluded. There is typically a delay of a few days between the date the study sponsor or investigator submitted the study record and the first posted date.
April 19, 2024

Study Record Updates

Last Update Posted (Actual)

Last Update Posted

The most recent date on which changes to a study record were made available on ClinicalTrials.gov. There may be a delay between when the changes were submitted to ClinicalTrials.gov by the study's sponsor or investigator (the last update submitted date) and the last update posted date.
April 19, 2024

Last Update Submitted That Met QC Criteria

Last Update Submitted That Met QC Criteria

The most recent date on which the study sponsor or investigator submitted changes to a study record that are consistent with National Library of Medicine (NLM) quality control (QC) review criteria. It is the responsibility of the sponsor or investigator to ensure that the study record is consistent with the NLM QC review criteria.
April 16, 2024

Last Verified

Last Verified

The most recent date on which the study sponsor or investigator confirmed the information about a clinical study on ClinicalTrials.gov as accurate and current. If a study with a recruitment status of recruiting; not yet recruiting; or active, not recruiting has not been confirmed within the past 2 years, the study's recruitment status is shown as unknown.
April 1, 2024

More Information

Terms related to this study

Keywords

Other Study ID Numbers

Other Study ID Numbers

Identifiers or ID numbers other than the NCT number that are assigned to a clinical study by the study's sponsor, funders, or others. These numbers may include unique identifiers from other trial registries and National Institutes of Health grant numbers.
  • TCM for Pre-COPD

Plan for Individual participant data (IPD)

Plan to Share Individual Participant Data (IPD)?

NO

Drug and device information, study documents

Studies a U.S. FDA-regulated drug product

No

Studies a U.S. FDA-regulated device product

No

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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