A randomized controlled trial for prevention of acute exacerbation of stable Chronic Obstructive Pulmonary Disease with acupoint application of traditional Chinese medicine

Phase 1

• Conditions: Chronic Obstructive Pulmonary Disease

• Registration Number: ITMCTR1900002670
• Lead Sponsor: Hospital of Chengdu University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Age ranged from 45 to 70 years, male or female.
2. In accordance with the COPD diagnostic criteria in the GOLD guidelines, and GOLD 2 to 3: FEV1/FVC <70% and 30% predicted value <= FEV1< 80% predicted value in 20 minutes after inhalation of salbutamol 400ug.
3. The patient is in a stable phase of COPD: the patient's symptoms such as cough, sputum, and shortness of breath are stable or mild, and the condition is basically restored to the state before acute exacerbation.
4. Patients with spleen-lung qi deficiency syndrome that meet the diagnostic criteria for common syndrome of traditional Chinese medicine.
5. Subjects volunteer to participate in the study and sign an informed consent form.

Exclusion Criteria

1. Combined with chronic lung diseases requiring intervention or treatment such as bronchial asthma,interstitial lung disease, active tuberculosis, bronchiectasis.
2. Combined with severe primary diseases such as severe mental disorders, cardiovascular and cerebrovascular diseases, liver and kidney diseases, endocrine diseases, hematopoietic system diseases, malignant tumors, etc.
3. There were skin wounds, skin ulcers and skin infections on the application site.
4. Those who are allergic to traditional Chinese medicine, excipients or dressings for the project.
5. Patients with limited limb movements.
6. Women who are breastfeeding, pregnant or preparing for pregnancy.
7. Participated in other clinical studies in the past six months.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
umber of exacerbations of COPD;

Secondary Outcome Measures

Name	Time	Method
TCM syndrome score;6-minute walk test;Pulmonary function measurement: FEV1 and FEV1/FVC change values;CAT score;mMRC Questionnaire;