Preserved Ratio Impaired SpirometryNCT06375824
Bufei Recipe Reduces the Incidence Rate of COPD
A study testing Bufei Recipe in people with Preserved Ratio Impaired Spirometry, run by Henan University of Traditional Chinese Medicine.
Trial summary
Establish early TCM prevention and treatment program to reduce the incidence rate of COPD. Read more about this study
- Who is it for?
- Ages 18 to 80 years
- Conditions the study is for
- Preserved Ratio Impaired Spirometry
- What is being tested?
- Bufei Recipe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 1,100 participants
- Where
- No sites listed yet
- Study dates
- 1 May 2024to 31 Oct 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
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 18 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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):
- smoking history (including previous and current smokers);
- 1 year or more of exposure to dust or chemical toxins;
- Indoor air pollution for 1 year or more (use of contaminated fuels, passive smoking, exposure) Oil fumes, etc.
- Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:
- Cough (more than 3 months per year, continuous for 2 years or more);
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- Coughing phlegm (more than 3 months per year, continuous for 2 years or more);
- Difficulty breathing (more than 3 months per year, continuous for 2 years or more).
- 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.
- Meets the diagnostic criteria for lung qi deficiency syndrome.
- Age range from 18 to 80 years old.
- Voluntarily participate in the study and sign an informed consent form.
Who cannot join
- 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.
Trial locations and contacts
No sites are listed yet. Contact the study team or a site near you to ask about taking part.
About this study
Official title: 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.
Read the 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.
- Conditions
- Preserved Ratio Impaired Spirometry
- Being tested
- Bufei Recipe, Bufei Recipe placebo
- Keywords
- Bufei Recipe, PRISm, incidence rate
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Bufei RecipeDrug
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.
Bufei Recipe placeboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Bufei Recipe | Experimental | 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. Receives: Drug: Bufei Recipe |
| Bufei Recipe placebo | Placebo comparator | 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. Receives: Drug: Bufei Recipe placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Incidence rate of COPD
Incidence rate of COPD
Measured: Change from baseline in the number of people with COPD at month 24.
Secondary outcomes (11)
FVC
Forced Vital Capacity (FVC) was mainly used for lung function evaluation
Measured: Change from baseline in FVC at months 12 and 24.
FEV1
Forced Expiratory Volume in One Second (FEV1) was mainly used for lung function evaluation
Measured: Change from baseline in FEV1 at months 12 and 24.
FEV1% pred
Percentage of Forced Expiratory Volume in One Second to Predicted Value (FEV1% pred) was mainly used for lung function evaluation
Measured: Change from baseline in FEV1% pred at months 12 and 24.
FEV1/FVC
Forced Expiratory Volume in One Second / Forced Vital Capacity (FEV1/FVC) was mainly used for lung function evaluation
Measured: Change from baseline in FEV1/FVC at months 12 and 24.
IPAG-Q
International Primary Airway Health Organization Questionnaire (IPAG-Q) was mainly used for chronic obstructive pulmonary screening score evaluation.
Measured: Change from baseline in IPAG-Q score at months 6, 12, 18, and 24.
LFQ
Lung Function Questionnaire (LFQ) was mainly used for chronic obstructive pulmonary screening score evaluation.
Measured: Change from baseline in LFQ score at months 6, 12, 18, and 24.
COPD-PS
Chronic Obstructive Pulmonary Disease Population Screening Questionnaire (COPD-PS) was mainly used for chronic obstructive pulmonary screening score evaluation.
Measured: Change from baseline in COPD-PS score at months 6, 12, 18, and 24.
CAT
Chronic Obstructive Pulmonary Disease Assessment (CAT) was mainly used for quality of life evaluation.
Measured: Change from baseline in CAT score at months 6, 12, 18, and 24.
SF-36
Health Survey Brief (SF-36) was mainly used for quality of life evaluation.
Measured: Change from baseline in SF-36 score at months 6, 12, 18, and 24.
Clinical symptoms
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.
Measured: Change from baseline in clinical symptom assessment questionnaire score at months 6, 12, 18, and 24.
Biochemical indicators
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.
Measured: Change from baseline in biochemical indicators at month 12 and 24.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted19 Apr 2024
- Study start1 May 2024 (estimated)
- Primary completion30 Apr 2027 (estimated)
- Study completion31 Oct 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Preserved Ratio Impaired SpirometryStudies 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
- 1,100 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- West China Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06375824
- Sponsor's protocol ID
- TCM for Pre-COPD
- Status last verified
- Apr 2024
- First submitted
- 2 Apr 2024
- Last updated
- 19 Apr 2024
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 19 Apr 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Bufei Recipe Reduces the Incidence Rate of COPD: A Multicenter, Randomized, Double Blind, Placebo Controlled Study
- ClinicalTrials.gov ID
- NCT06375824
- Acronym / sponsor ID
- TCM for Pre-COPD
- Conditions
- Preserved Ratio Impaired Spirometry
- Keywords
- Bufei Recipe, PRISm, incidence rate
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 1,100 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- West China Hospital, The First Affiliated Hospital of Zhejiang Chinese Medical University
- Study start
- 1 May 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 19 Apr 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.
Establish early TCM prevention and treatment program to reduce the incidence rate of COPD.
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 design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Bufei Recipe | Experimental | Drug: Bufei RecipeBu 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. |
| Bufei Recipe placebo | Placebo comparator | Drug: Bufei Recipe placeboThe 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. |
Who may qualify
- Ages
- 18 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (12 listed)
- 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):
- Have a history of chronic bronchitis and/or emphysema, and have one of the following chronic respiratory symptoms:
- 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.
- Meets the diagnostic criteria for lung qi deficiency syndrome.
- Age range from 18 to 80 years old.
Key exclusion criteria (8 listed)
- 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.
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 RecipeBufei 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. | Drug | Bufei Recipe |
| Bufei Recipe placeboThe 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 |
Primary outcome
Incidence rate of COPD
Time frame: Change from baseline in the number of people with COPD at month 24.
Incidence rate of COPD
11 secondary outcomes
FVC
Time frame: Change from baseline in FVC at months 12 and 24.
FEV1
Time frame: 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.
FEV1/FVC
Time frame: 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.
LFQ
Time frame: 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.
CAT
Time frame: 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.
Clinical symptoms
Time frame: 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.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 19 Apr 2024.
- 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.
Questions about this trial
What is this clinical trial studying?
A study testing Bufei Recipe in people with Preserved Ratio Impaired Spirometry, 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 12 inclusion and 8 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: opening soon, as of the sponsor's last update on 19 Apr 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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact yang xie (0371-66248624, xieyanhn@163.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Incidence rate of COPD (time frame: Change from baseline in the number of people with COPD at month 24.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 19 Apr 2024.