Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD

October 18, 2024 updated by: Henan University of Traditional Chinese Medicine

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.

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

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 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.
468

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. Patients with severe AECOPD.;
  2. Age 40-80 years old;
  3. 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;
  4. Voluntarily accept the treatment and sign the informed consent form;

Exclusion Criteria:

  1. Pregnant and lactating women.
  2. delirious, dementia, various mental patients and other people who cannot communicate normally.
  3. Patients with severe cardiac insufficiency (NYHA grade IV), malignant arrhythmia and hemodynamic instability.
  4. Patients with acute respiratory failure who require tracheal intubation or invasive mechanical ventilation.
  5. 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.
  6. long-term bedridden patients for various reasons.
  7. Out-of-hospital treatment for more than 3 days.
  8. Participate in other drug clinical investigators within 1 month before enrollment.
  9. Allergic to therapeutic 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: Chinese medicine granules plus western medicine treatment
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.
Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe
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.
Placebo Comparator: Chinese medicine granules placebo plus western medicine treatment
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.
Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo
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.

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
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.
During the 10 days treatment period and the 3 months follow-up period.

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
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 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.
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.
The number and severity of acute exacerbations during the follow-up period.
Within 3 months of follow-up period.
Readmission rate of acute exacerbations
Time Frame: Within 3 months of follow-up period.
The number of readmissions due to acute exacerbations during the follow-up period.
Within 3 months of follow-up period.
The time to the first exacerbation of COPD
Time Frame: Within 3 months of follow-up period.
The time to the first COPD exacerbation during the study period.
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.
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.
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.
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.
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.
Through study /treatment phase completion,an average of 10 days.
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.
The antibacterial application time of each group of subjects was counted.
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.
The number of endotracheal intubation cases in the two groups during the treatment period was calculated.
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.
The number of deaths due to AECOPD in the two groups during the study period was counted.
During the 10 days treatment period and the 3 months follow-up period.

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.
Jiangsu Province Hospital of Traditional Chinese Medicine
Peking University Third Hospital
Chengdu University of Traditional Chinese Medicine
Qingdao Haici Hospital
Shenzhen Hospital of Southern Medical University
First Affiliated Hospital of Liaoning University of Traditional Chinese Medicine
Xiangyang Hospital of Traditional Chinese Medicine

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.
October 20, 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).
May 28, 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.
June 7, 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.
June 12, 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.
October 22, 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.
October 18, 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.
October 1, 2024

More Information

Terms related to this study

Additional Relevant MeSH Terms

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.
  • CM for Severe AECOPD

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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