Acute Exacerbation Of Chronic Obstructive Pulmonary DiseaseNCT06455670
Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD
A study testing Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe in people with Acute Exacerbation Of Chronic Obstructive Pulmonary Disease, run by Henan University of Traditional Chinese Medicine.
Trial summary
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD. Read more about this study
- Who is it for?
- Ages 40 to 80 years
- Conditions the study is for
- Acute Exacerbation Of Chronic Obstructive Pulmonary Disease
- What is being tested?
- Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 468 participants
- Where
- No sites listed yet
- Study dates
- 20 Oct 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 40 to 80 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Patients with severe AECOPD.;
- Age 40-80 years old;
- Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
- Voluntarily accept the treatment and sign the informed consent form;
Who cannot join
- Pregnant and lactating women.
- delirious, dementia, various mental patients and other people who cannot communicate normally.
- Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
- Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
- Complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, HIV infection or immunosuppressive state, advanced malignant tumor, etc.
- long-term bedridden patients for various reasons.
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- Out-of-hospital treatment for more than 3 days.
- Participate in other drug clinical investigators within 1 month before enrollment.
- Allergic to therapeutic 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: Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.
Read the detailed description
Aiming at the key problems such as the lack of high-quality clinical research evidence of Chinese medicine in the prevention and treatment of severe AECOPD, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe AECOPD patients as the research object, to evaluate the clinical efficacy and safety of Chinese medicine combined with western medicine in the treatment of severe AECOPD. To establish an integrated Chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe AECOPD patients, and to form high-level evidence-based evidence.
- Being tested
- Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe, Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipeDrug
On the basis of conventional treatment of western medicine,the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days.
Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placeboDrug
On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days.
| Study group | Role | What they receive |
|---|---|---|
| Chinese medicine granules plus western medicine treatment | Experimental | On the basis of conventional western medicine treatment, the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days. Receives: Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe |
| Chinese medicine granules placebo plus western medicine treatment | Placebo comparator | On the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days. Receives: Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
Treatment failure rate
The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.
Measured: During the 10 days treatment period and the 3 months follow-up period.
Secondary outcomes (10)
The COPD Assessment Test(CAT)
The COPD Assessment Test (CAT) is an 8-item questionnaire that assesses health status in patients with COPD. The questionnaire uses a 0-5 point scale, with higher values indicating a greater impact of COPD on the patient.
Measured: Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.
The number and severity of acute exacerbations
The number and severity of acute exacerbations during the follow-up period.
Measured: Within 3 months of follow-up period.
Readmission rate of acute exacerbations
The number of readmissions due to acute exacerbations during the follow-up period.
Measured: Within 3 months of follow-up period.
The time to the first exacerbation of COPD
The time to the first COPD exacerbation during the study period.
Measured: Within 3 months of follow-up period.
Dyspnea score
The modified Medical Research Council dyspnoea scale (mMRC) will be used to assess severity of dyspnea. The mMRC scale is a 4-point (0-4) scale. "0" means no dyspnea perception, "4" means severe dyspnea perception.
Measured: Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.
COPD Acute exacerbation tool (EXACT) score
The EXAcerbations of Chronic Pulmonary Disease Tool (EXACT) is a questionnaire that assesses symptoms in patients with COPD. The questionnaire is on a scale from 0 to 5, with higher values indicating a greater impact of COPD on the patient.
Measured: 0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.
Length of hospital stay
Through study /treatment phase completion,an average of 10 days.
Measured: During the 10 days treatment period and the 3 months follow-up period.
Antibacterial application time
The antibacterial application time of each group of subjects was counted.
Measured: During the 10 days treatment period and the 3 months follow-up period.
Endotracheal intubation rate
The number of endotracheal intubation cases in the two groups during the treatment period was calculated.
Measured: In 10 days of the treatment period.
Case fatality rate
The number of deaths due to AECOPD in the two groups during the study period was counted.
Measured: During the 10 days treatment period and the 3 months follow-up period.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Jun 2024
- Study start20 Oct 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 Acute Exacerbation Of 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
- 468 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Henan University of Traditional Chinese Medicine
- Sponsor type
- University, hospital or other
- Collaborators
- Peking University Third Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenzhen Hospital of Southern Medical University, Qingdao Haici Hospital, Xiangyang Hospital of Traditional Chinese Medicine
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06455670
- Sponsor's protocol ID
- CM for Severe AECOPD
- Status last verified
- Oct 2024
- First submitted
- 28 May 2024
- Last updated
- 22 Oct 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 22 Oct 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial
- ClinicalTrials.gov ID
- NCT06455670
- Acronym / sponsor ID
- CM for Severe AECOPD
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 468 participants (estimated)
- Lead sponsor
- Henan University of Traditional Chinese MedicineUniversity, hospital or other
- Collaborators
- Peking University Third Hospital, Jiangsu Province Hospital of Traditional Chinese Medicine, Chengdu University of Traditional Chinese Medicine, Affiliated Hospital of Liaoning University of Traditional Chinese Medicine, Shenzhen Hospital of Southern Medical University, Qingdao Haici Hospital, Xiangyang Hospital of Traditional Chinese Medicine
- Study start
- 20 Oct 2024 (estimated)
- Primary completion
- 30 Apr 2027 (estimated)
- Study completion
- 31 Oct 2027 (estimated)
- First posted
- 12 Jun 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.
The purpose of this study was to evaluate the effects of Chinese Medicine on patients with severe AECOPD, and to provide a basis for the establishment of integrated CM and Western medicine diagnosis and treatment scheme for patients with severe AECOPD.
Detailed description
Aiming at the key problems such as the lack of high-quality clinical research evidence of Chinese medicine in the prevention and treatment of severe AECOPD, this study adopted a multi-center, randomized, double-blind, placebo-controlled parallel trial design, taking 468 severe AECOPD patients as the research object, to evaluate the clinical efficacy and safety of Chinese medicine combined with western medicine in the treatment of severe AECOPD. To establish an integrated Chinese and western medicine diagnosis and treatment plan to reduce the treatment failure rate of severe AECOPD patients, and to form high-level evidence-based evidence.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Chinese medicine granules plus western medicine treatment | Experimental | Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipeOn the basis of conventional western medicine treatment, the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days. |
| Chinese medicine granules placebo plus western medicine treatment | Placebo comparator | Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placeboOn the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days. |
Who may qualify
- Ages
- 40 to 80 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Patients with severe AECOPD.;
- Age 40-80 years old;
- Chinese medicine diagnosis consistent with external cold and internal drink syndrome, or phlegm-heat congestion of the lungs syndrome, or phlegm turbidity obstruction of the lungs syndrome;
- Voluntarily accept the treatment and sign the informed consent form;
Key exclusion criteria (9 listed)
- Pregnant and lactating women.
- delirious, dementia, various mental patients and other people who cannot communicate normally.
- Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
- Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
- Complicated with bronchiectasis, active tuberculosis, severe liver and kidney disease (severe liver disease refers to cirrhosis, portal hypertension and varicose vein bleeding, etc., serious kidney disease including dialysis, kidney transplantation, etc.), pneumonia, HIV infection or immunosuppressive state, advanced malignant tumor, etc.
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 |
|---|---|---|
| Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipeOn the basis of conventional treatment of western medicine,the experimental group will be given Sanhan Huayin granule , Qingre Huatan granule or Zaoshi Huatan granule based on CM syndrome differentiation.Take 1 dose daily for 10 days. | Drug | Chinese medicine granules plus western medicine treatment |
| Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placeboOn the basis of conventional treatment of western medicine, in the experimental group 5% of the placebo drug, color, smell, taste, appearance, weight, similar to the experimental drug, drug packaging and test group. One dose was given daily for 10 days. | Drug | Chinese medicine granules placebo plus western medicine treatment |
Primary outcome
Treatment failure rate
Time frame: During the 10 days treatment period and the 3 months follow-up period.
The number of treatment failures in both groups during the study period was measured. Treatment failure was defined as the following: (1) the need for or receipt of tracheal intubation or invasive mechanical ventilation during hospitalization, or (2) the need for or transfer to an intensive care unit during hospitalization, or (3) the duration of hospitalization for the current acute exacerbation of COPD for more than 14 days, or (4) death during hospitalization or within 30 days after discharge, or (5) readmission for an acute exacerbation of COPD within 30 days after discharge.
10 secondary outcomes
The COPD Assessment Test(CAT)
Time frame: Changes in baseline CAT scores at day 10 of the treatment period and at 1 and 3 months of follow-up.
The number and severity of acute exacerbations
Time frame: Within 3 months of follow-up period.
Readmission rate of acute exacerbations
Time frame: Within 3 months of follow-up period.
The time to the first exacerbation of COPD
Time frame: Within 3 months of follow-up period.
Dyspnea score
Time frame: Changes in baseline mMRC scores at days 4, 7, and 10 of the treatment period and at 1 and 3 months of follow-up.
COPD Acute exacerbation tool (EXACT) score
Time frame: 0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.
Length of hospital stay
Time frame: During the 10 days treatment period and the 3 months follow-up period.
Antibacterial application time
Time frame: During the 10 days treatment period and the 3 months follow-up period.
Endotracheal intubation rate
Time frame: In 10 days of the treatment period.
Case fatality rate
Time frame: During the 10 days treatment period and the 3 months follow-up period.
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 22 Oct 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 Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe in people with Acute Exacerbation Of 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 4 inclusion and 9 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 22 Oct 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 Hailong Zhang, doctor (+86-0371-66211586, zhanghailong6@126.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Treatment failure rate (time frame: During the 10 days treatment period and the 3 months follow-up period.). 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 22 Oct 2024.