community-acquired pneumonia
Conditions
Interventions
Trial group:Basic therapy + Qingke Pingchuan Granule
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) 18 years old = age = 80 years old, gender is not limited; (2) meet the diagnostic criteria of community-acquired pneumonia; (3) meet the diagnostic criteria of phlegm-heat obstructing lung syndrome in traditional Chinese medicine; (4) the CURB-65 score of 0-2; (5) the clinical symptoms of the subjects need to be manifested as at least three of the following five main symptoms: cough, cough sputum, chest pain, fever, and pulmonary rhonchi; and (6) voluntarily participate in this clinical trial, gave informed consent and signed an informed consent form.
Exclusion criteria
Exclusion criteria: (1) patients with severe CAP; (2) interstitial pneumonia, hospital-acquired pneumonia (including ventilator-associated pneumonia); (3) patients with serious complications such as pleural effusion, pyothorax, lung abscess, pulmonary atelectasis, and ARDS; (4) patients with other more serious respiratory diseases, such as chronic obstructive pulmonary disease, bronchial asthma, bronchodilatation, active pulmonary tuberculosis, and other primary diseases of the lung; (5) Combination of serious heart, brain, liver, kidney, blood system diseases and mental diseases and other underlying diseases; (6) The use of Chinese and western medicines that have the effect of clearing heat, resolving phlegm and relieving cough within 48 hours prior to enrollment or the use of drugs that have antimicrobial effects clearly defined by modern pharmacology; (7) Suffering from serious diseases affecting the immune system, such as malignant tumors, organ or bone marrow transplantation, HIV infection, or the use of immunosuppressants or systemic glucocorticosteroids in the past 3 months. glucocorticoid subjects; (8) dysphagia or a history of gastrointestinal disorders affecting the absorption of the test drug (including, but not limited to, chronic diarrhoea, reflux oesophagitis, ulcerative colitis, intestinal tuberculosis, gastrinoma, short bowel syndrome, and post-gastric resection of the major gastric resections); (9) combined diabetes mellitus with unstable glycaemic control and a glycated haemoglobin control target of >7%; (10) pregnancy, planned (10) Pregnant, planning to be pregnant and breastfeeding subjects; (11) Previous history of drug abuse, drug abuse; (12) Previous history of severe allergic reaction, or known allergy to cough particles or ingredients; (13) Participated in the last 3 months or are participating in other clinical trials; (14) According to the investigator's judgement, other conditions are unsuitable for the participation of this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The proportion of subjects whose disease meets the effective criteria on the 7th day; | — |
Secondary
| Measure | Time frame |
|---|---|
| Cough and sputum assessment questionnaire (CASA-Q) on day 7 of dosing;;TCM symptom scores on days 3, 5 and 7 of dosing;;Number of days in hospital for patients hospitalised with different pathogen infections;;Clinical signs and symptoms scores (including cough, sputum, chest pain, fever, and lung rales) on days 3, 5, and 7 of dosing;;The rate of disappearance of single clinical signs and symptoms (cough, sputum, chest pain, fever, and lung rales) on days 3, 5, and 7 of dosing;;Day 14 transfer weight rate;;Peripheral blood inflammation indicators on day 7 of dosing: white blood cell count (WBC), C-reactive protein (CRP), procalcitonin (PCT), interleukin-6 (IL-6), serum amyloid A (SAA);;Day 7 discharge rate;;Clinical Pulmonary Infection (CPIS) score on day 7 of dosing;;Day 7 pathogenetic clearance;;Medical costs.;Modified Pneumonia Imaging Uptake Evaluation Scale on Day 7 of dosing;; | — |
Countries
China
Contacts
Public ContactZhang Wei
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine, Shanghai
Outcome results
None listed