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

NCT ID: NCT06455670

Last Updated: 2024-10-22

Basic Information

• Recruitment Status: NOT_YET_RECRUITING
• Clinical Phase: NA
• Total Enrollment: 468 participants
• Study Classification: INTERVENTIONAL
• Study Start Date: 2024-10-20
• Study Completion Date: 2027-10-31

Brief 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.

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.

Conditions

Acute Exacerbation Of Chronic Obstructive Pulmonary Disease

Study Design

• Allocation Method: RANDOMIZED
• Intervention Model: PARALLEL
• Primary Study Purpose: TREATMENT
• Blinding Strategy: DOUBLE

Study Groups

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.

Group Type: EXPERIMENTAL

Sanhan Huayin recipe, Qingre Huatan recipe or Zaoshi Huatan recipe

Intervention Type: DRUG

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.

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.

Group Type: PLACEBO_COMPARATOR

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

Intervention Type: DRUG

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.

Interventions

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.

Intervention Type: 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.

Intervention Type: DRUG

Eligibility Criteria

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.

• Minimum Eligible Age: 40 Years
• Maximum Eligible Age: 80 Years
• Eligible Sex: ALL
• Accepts Healthy Volunteers: No

Sponsors

Peking University Third Hospital

OTHER

Sponsor Role: collaborator

Jiangsu Province Hospital of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Chengdu University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Affiliated Hospital of Liaoning University of Traditional Chinese Medicine

OTHER

Sponsor Role: collaborator

Shenzhen Hospital of Southern Medical University

OTHER

Sponsor Role: collaborator

Qingdao Haici Hospital

OTHER

Sponsor Role: collaborator

Xiangyang Hospital of Traditional Chinese Medicine

UNKNOWN

Sponsor Role: collaborator

Henan University of Traditional Chinese Medicine

OTHER

Sponsor Role: lead

Responsible Party

Responsibility Role: SPONSOR

Central Contacts

Hailong Zhang, doctor

Role: CONTACT

zhanghailong6@126.com

+86-0371-66211586

Hailong Zhang, doctor

Role: CONTACT

zhanghailong6@126.com

+86-0371-66248624

Other Identifiers

CM for Severe AECOPD

Identifier Type: -

Identifier Source: org_study_id