A randomized, double-blind, placebo parallel-controlled, multi-center clinical trial to evaluate the effectiveness and safety of Tanyin Pills in the treatment of stable COPD (spleen-kidney yang deficiency, phlegm-yin obstructing lung syndrome) with AECOPD as the endpoint event

Phase 4

• Conditions: COPD stable period

• Registration Number: ITMCTR2100005065
• Lead Sponsor: West China Hospital of Sichuan University

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: Male
• Target Recruitment: Not specified

Inclusion Criteria

1. Meet the diagnostic criteria of western medicine for chronic obstructive pulmonary disease;
2. Outpatients with moderate to severe lung function in compliance with GOLD;
3. In line with patients with high risk of acute exacerbation;
4. Comply with the syndrome differentiation standard of spleen and kidney yang deficiency and phlegm-drinking obstructing lung syndrome;
5. Aged from 40 to 80 years;
6. Agree to participate in this study and sign an informed consent form.

Exclusion Criteria

1. Accompanied by asthma, active tuberculosis, lung cancer, bronchiectasis, pulmonary embolism, pulmonary heart disease, pulmonary interstitial disease or other active diseases;
2. Patients with AECOPD or infection within 1 month before the consultation;
3. Patients who need long-term oxygen therapy (daily oxygen inhalation time >=12h) or patients undergoing pulmonary rehabilitation;
4. Pneumonectomy in the past, or lung volume reduction surgery within 12 months before screening;
5. Those suffering from severe hypertension, heart failure, arrhythmia, diabetes, tumors, and unsatisfactory control of primary heart, liver, kidney, and blood system diseases;
6. Kidney Scr exceeds the upper limit of the reference value by 1.5 times, or the liver function test AST, ALT >=2 times the upper limit of the reference value;
7. Those with known or suspected history of alcohol or drug abuse;
8. Pregnant or lactating women or those planning to become pregnant during the study period;
9. Those who are allergic to the ingredients of the study drug and those who are not suitable for use in the instructions;
10. Those who have participated in other clinical trials within the past 3 months;
11. Those who are judged by the investigator to be unsuitable to participate in this clinical trial.

Study & Design

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

Primary Outcome Measures

Name	Time	Method
Time of first AECOPD attack;

Secondary Outcome Measures

Name	Time	Method
Adrenocortical function(serum cortisol, 24-hour urine 17-hydroxycorticosteroid, 24-hour urine 17-ketone steroid);The CAT score;TCM syndrome integral;Immunological indicators(CD4+, CD8+, CD4+/CD8+, IgA, IgG, IgM);Inflammatory factors(IL-6, IL-8, IL-15, TNF-a and CRP);The severity of the first AECOPD;6 minutes walking distance;Lung function (FEV1, FVC, FEV1/FVC);MMRC dyspnea score;Cough, phlegm, and dyspnea score (BCSS);Number of AECOPD attacks;