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

Официальное название

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

Обзор

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.

Подробное описание

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.

Вмешательства

• Препарат 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.
• Препарат 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.

Первичные конечные точки

• Treatment failure rate [Срок оценки: During the 10 days treatment period and the 3 months follow-up period.]

Вторичные конечные точки (10)

• The COPD Assessment Test(CAT) [Срок оценки: 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 [Срок оценки: Within 3 months of follow-up period.]
• Readmission rate of acute exacerbations [Срок оценки: Within 3 months of follow-up period.]
• The time to the first exacerbation of COPD [Срок оценки: Within 3 months of follow-up period.]
• Dyspnea score [Срок оценки: 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 [Срок оценки: 0 and 10 days in the treatment period, 1 and 3 months in the follow-up period.]
• Length of hospital stay [Срок оценки: During the 10 days treatment period and the 3 months follow-up period.]
• Antibacterial application time [Срок оценки: During the 10 days treatment period and the 3 months follow-up period.]
• Endotracheal intubation rate [Срок оценки: In 10 days of the treatment period.]
• Case fatality rate [Срок оценки: During the 10 days treatment period and the 3 months follow-up period.]

Критерии участия

Критерии включения

• 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;

Критерии исключения

• 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.

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Двойное слепое

Основная цель

Лечение

Центры проведения

Список центров уточняется — проверьте первичный протокол.

Идентификаторы

NCT: NCT06455670 · CM for Severe AECOPD

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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