Chronic Obstructive Pulmonary DiseaseNCT06143358
Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
A study testing Qingkepingchuan Granules and conventional treatment in people with Chronic Obstructive Pulmonary Disease, run by Zhang Zhijie at 1 site in China.
Trial summary
Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the… Read more about this study
- Who is it for?
- Ages 40 to 90 years
- Conditions the study is for
- Chronic Obstructive Pulmonary Disease
- What is being tested?
- Qingkepingchuan Granules and conventional treatment
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 100 participants
- Where
- 1 siteChina
- Study dates
- 1 Jan 2022to 7 Jul 2023
- 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 90 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Meet the diagnostic criteria of AECOPD.
- Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence
- 40 years old ≤ age ≤ 90 years old
- Patients who signed the informed consent form and volunteered to participate in the study
Who cannot join
- Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.
- Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.
- Pregnant or lactating patients.
- Allergic to the clinical trial drugs.
Trial locations and contacts
1 site in 1 country.
About this study
Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.
- Conditions
- Chronic Obstructive Pulmonary Disease
- Being tested
- Qingkepingchuan Granules, conventional treatment
- 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.
Qingkepingchuan GranulesDrug
Qingkepingchuan Granules,Take it three times a day with water after meals.
conventional treatmentOther
Oxygen intake, selection of appropriate antibiotics based on lab results, and other treatments
| Study group | Role | What they receive |
|---|---|---|
| treatment group | Experimental | Qingkepingchuan Granules+Conventional basic therapy Receives: Drug: Qingkepingchuan Granules |
| control subjects | Other | Conventional basic therapy Receives: Other: conventional treatment |
What is being measured
The primary outcome is the main question the study is designed to answer.
Chinese Medicine Symptoms Scale
Record changes in patients' TCM indicators。The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes.
Measured: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
COPD assessment test
Record changes in the patient's condition
Measured: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
breathlessness measurement using the modified British Medical Research Council
Record changes in the patient's condition
Measured: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Secondary outcomes (1)
6-minute walking test
Record changes in the patient's condition
Measured: Before the start of treatment, 2 weeks of treatment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted22 Nov 2023
- Study start1 Jan 2022
- Primary completion7 Jul 2023
- Study completion7 Jul 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- 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
- Model description
- Qingkepingchuan Granules
- Masking
- None (open label)
- Enrolment
- 100 participants (actual)
Sponsor and investigators
- Lead sponsor
- Zhang Zhijie
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Zhang Zhijie, Beijing University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06143358
- Sponsor's protocol ID
- SY-1
- Status last verified
- Nov 2023
- First submitted
- 16 Nov 2023
- Last updated
- 24 Nov 2023
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 24 Nov 2023. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Treatment of Acute Exacerbation of Chronic Obstructive Pulmonary Disease With Qingkepingchuan Granules Clinical Observation of Phlegm-Heat and Lung Depletion
- ClinicalTrials.gov ID
- NCT06143358
- Acronym / sponsor ID
- SY-1
- Conditions
- Chronic Obstructive Pulmonary Disease
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 100 participants (actual)
- Lead sponsor
- Zhang ZhijieUniversity, hospital or other
- Study start
- 1 Jan 2022 (actual)
- Primary completion
- 7 Jul 2023 (actual)
- Study completion
- 7 Jul 2023 (actual)
- First posted
- 22 Nov 2023 (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.
Through the clinical observation of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease (phlegm-heat lung syndrome), (1) to evaluate the safety of Qingcheng Pingxian Granules in the acute exacerbation of chronic obstructive pulmonary disease; (2) to observe the clinical efficacy of Qingcheng Pingxian Granules in the treatment of acute exacerbation of chronic obstructive pulmonary disease, to provide an effective medication and solution for the treatment of acute exacerbation of chronic obstructive pulmonary disease, and to provide data for the development of the further application of Qingcheng Pingxian Granules.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 2
- Model description
- Qingkepingchuan Granules
| Arm | Type | Receives |
|---|---|---|
| treatment group | Experimental | Drug: Qingkepingchuan GranulesQingkepingchuan Granules+Conventional basic therapy |
| control subjects | Other | Other: conventional treatmentConventional basic therapy |
Who may qualify
- Ages
- 40 to 90 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Meet the diagnostic criteria of AECOPD.
- Chinese medicine diagnosis is consistent with phlegm-heat and lung depletion evidence
- 40 years old ≤ age ≤ 90 years old
- Patients who signed the informed consent form and volunteered to participate in the study
Key exclusion criteria (4 listed)
- Combined with other primary lung diseases such as bronchial asthma, bronchiectasis, etc.
- Combination of serious cardiovascular, urinary, digestive, haematopoietic, endocrine metabolic system diseases, other psychiatric and neurological diseases.
- Pregnant or lactating patients.
- Allergic to the clinical trial drugs.
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 |
|---|---|---|
| Qingkepingchuan GranulesQingkepingchuan Granules,Take it three times a day with water after meals. | Drug | treatment group |
| conventional treatmentOxygen intake, selection of appropriate antibiotics based on lab results, and other treatments | Other | control subjects |
Primary outcome
Chinese Medicine Symptoms Scale
Time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Record changes in patients' TCM indicators。The scale includes cough, wheezing, shortness of breath, sputum volume, chest tightness, sputum colour, sputum quality, fever, thirst, irritability, constipation, tongue coating, and pulse. The first four items are rated 0-6, and the last nine items are rated 0-3, with higher ratings indicating poorer treatment outcomes.
COPD assessment test
Time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Record changes in the patient's condition
breathlessness measurement using the modified British Medical Research Council
Time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up
Record changes in the patient's condition
1 secondary outcome
6-minute walking test
Time frame: Before the start of treatment, 2 weeks of treatment
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 24 Nov 2023.
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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.
The record lists no contact. Use the official record to reach the sponsor.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Qingkepingchuan Granules and conventional treatment in people with Chronic Obstructive Pulmonary Disease, run by Zhang Zhijie at 1 site in China.
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 4 inclusion and 4 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: finished, as of the sponsor's last update on 24 Nov 2023. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. 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?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Chinese Medicine Symptoms Scale (time frame: Before the start of treatment, 1 week of treatment, 2 weeks of treatment, 1 month of follow-up). The study lists 3 primary outcomes in all. 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 24 Nov 2023.