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

Henan University of Traditional Chinese Medicine

Status: Not yet enrolling

Conditions: Acute Exacerbation Of Chronic Obstructive Pulmonary Disease

Treatments: Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo; Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe

Study type: Interventional

Funder types: Other

Identifiers

NCT06455670

CM for Severe AECOPD

Details and patient eligibility

About

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.

Full 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.

Enrollment: 468 estimated patients

Sex: All

Ages: 40 to 80 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Treatment

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: Double Blind

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468 participants in 2 patient groups, including a placebo group

Chinese medicine granules plus western medicine treatment

Experimental group

Description:

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.

Treatment:

Drug: Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe

Chinese medicine granules placebo plus western medicine treatment

Placebo Comparator group

Description:

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.

Treatment:

Drug: Sanhan Huayin recipe placebo, Qingre Huatan recipe placebo or Zaoshi Huatan recipe placebo