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Not yet recruiting NCT06455670

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

No phase Interventional Acute Exacerbation Of Chronic Obstructive Pulmonary Disease

For patients and families

In plain language

An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.

What is being studied
The protocol lists: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe, Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo.
Who it may be relevant to
Registry conditions: Acute Exacerbation Of Chronic Obstructive Pulmonary Disease. Basic parameters: 40 years — 80 years · All.
What needs checking
Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
Where it takes place
Center list to be confirmed — check the primary protocol.
Next step
Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →

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Official title

Effects of Chinese Medicine on Patients With Severe Acute Exacerbation of COPD：A Multicentre, Randomised, Double-blind, Placebo-parallel Controlled Trial

Overview

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.

Interventions

  • 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.
  • 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.

Primary outcome measures

  • Treatment failure rate [Time frame: During the 10 days treatment period and the 3 months follow-up period.]
Secondary outcome measures (10)
  • 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.]

Eligibility criteria

Inclusion criteria

  • 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;

Exclusion criteria

  • 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.
  • Out-of-hospital treatment for more than 3 days.
  • Participate in other drug clinical investigators within 1 month before enrollment.
  • Allergic to therapeutic drugs.

Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.

Healthy volunteers: No

Study design

Allocation
Randomized
Model
Parallel assignment
Masking
Double blind
Primary purpose
Treatment

Study locations

Center list to be confirmed — check the primary protocol.

Identifiers

NCT: NCT06455670 · CM for Severe AECOPD

Primary sources (government registries)

View this study on ClinicalTrials.gov ↗