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A prospective, randomized, double-blind, placebo-controlled and multicenter trial for Tanreqing capsule in the treatment of patients with AECOPD with upper respiratory tract infection

A prospective, randomized, double-blind, placebo-controlled and multicenter trial for Tanreqing capsule in the treatment of ?patients with AECOPD with upper respiratory tract infection

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005207
Enrollment
Unknown
Registered
2021-09-09
Start date
2020-03-20
Completion date
Unknown
Last updated
2023-02-20

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Chronic obstructive pulmonary disease

Interventions

Sponsors

Shanghai Minhang District Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
40 Years to 85 Years

Inclusion criteria

Inclusion criteria: 1) Aged 40-85 years; 2) COPD meets the diagnostic criteria for COPD formulated by the Chinese Society of Respiratory Diseases; there has been a report of lung function diagnosis in the past year, that is, FEV1/FVC= 30%; 3) This outpatient visit due to upper respiratory tract infection; 4) At least two of URTI symptoms such as sore throat, nasal congestion, runny nose, sneezing, or flu toxicity symptoms such as fever, headache, and myalgia occurred in the past 3 days; 5) There is no newly added rales in the lungs; 6) There is no new exudation on chest radiograph or lung CT; 7) Imaging examination: In line with chronic bronchitis and emphysema, no new pulmonary exudation was seen. Exclude pulmonary tuberculosis, lung tumors, pulmonary embolism, interstitial lung disease and pulmonary edema. (Secondary mild bronchiectasis is not ruled out); 8) Sign the informed consent form.

Exclusion criteria

Exclusion criteria: 1) Patients with bronchiectasis with hemoptysis, or patients with obvious bronchiectasis on imaging; 2) The patient had other active lung diseases before enrollment, such as active tuberculosis, lung cancer, pulmonary embolism, sarcoidosis, interstitial lung disease, primary pulmonary hypertension and bronchial asthma, etc.; 3) Those with severe liver and kidney insufficiency, cardiac insufficiency, etc. who need corresponding medical treatment; 4) Subjects with unstable ischemic heart disease, myocardial infarction and cerebrovascular accident within 6 months before enrollment, acute coronary syndrome within 3 months or underwent percutaneous coronary intervention or paracoronary artery Subjects of road transplantation; 5) Subjects who have mental illness, mental retardation, poor motivation, drug and alcohol abuse, or other restrictions on participating in this study; 6) Participated in other clinical trials within 4 weeks before enrollment; 7) Women who are pregnant or breastfeeding or plan to become pregnant during the study period, or women who are fertile but have not used effective contraceptive methods (women of childbearing age should check urine HCG); 8) Those who are allergic to Tanreqing capsule drugs.

Design outcomes

Primary

MeasureTime frame
Dyspnea, cough and expectoration scale;TCM clinical syndrome index;

Secondary

MeasureTime frame
Electrocardigram;ALT;Sputum culture;Pulmonary function;Routine blood test;PCT;CRP;AST;

Countries

China

Contacts

Public ContactGao Xiwen

Shanghai Minhang District Central Hospital

xiwengao@sina.com+86 18918169812

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026