Clinical study of Lian Bizhi injection in the treatment of adult community-acquired pneumonia
- Conditions
- community-aquired pneumonia
- Registration Number
- ITMCTR2000003510
- Lead Sponsor
- China-Japan Friendship Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- Not specified
All of the following criteria must be met during screening before being included in the trial:
(1) Inpatients who meet the diagnosis of adult community-acquired pneumonia;
(2) TCM syndrome differentiation is the syndrome of phlegm-heat obstructing the lung;
(3) Body temperature >=37.5 degree C;
(4) CURB-65 score <=2 points;
(5) The PSI score for pneumonia belongs to low-risk grade I to III (<=90 points);
(6) Aged 18 to 65 years old;
(7) Volunteer to participate in clinical trials and sign informed consent.
All of the following criteria must not be met during screening before being included in the trial:
(1) Cough caused by chronic pharyngitis, chronic obstructive pulmonary disease, bronchial asthma, pulmonary fibrosis, tuberculosis, whooping cough, acute tonsillitis, fungus, tumor and other factors;
(2) Those who have used antibiotics and antiviral drugs within one week before screening, including Chinese medicines and proprietary Chinese medicines that have a therapeutic effect on pneumonia;
(3) Diabetics with poor blood sugar control (Poor blood sugar control here refers to those with fasting blood sugar>7.0mmol/L);
(4) Those with a history of central nervous system diseases and epilepsy;
(5) Kidney function Scr is greater than the upper limit of the reference value; liver function ALT, AST>1.5 times the upper limit of the reference value;
(6) Patients with severe primary diseases of the cardio-cerebrovascular, liver and kidney hematopoietic system and endocrine system, and mental patients;
(7) Allergic physique, and those who are allergic to the active ingredient of the drug (sodium bisulfite and andrographolide), levofloxacin hydrochloride injection and excipients;
(8) Women who are pregnant or planning to become pregnant, breastfeeding women, patients of childbearing age who are unable or unwilling to take adequate contraception during the trial, or their spouses who are unwilling to take contraceptive measures;
(9) Participated in or are participating in other drug clinical trials within 3 months;
(10) According to the judgment of the researcher, it is not suitable to participate in this research.
Study & Design
- Study Type
- Interventional study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Time to normal body temperature;Immediate onset time;Initial treatment efficiency;Initial treatment failure rate;Use of antipyretics;Neutrophil count;CRP value;Lung rale score;VAS rating of cough;White blood cell count;Sputum volume score;ESR value;Theoretical discharge time;
- Secondary Outcome Measures
Name Time Method Medical examination;Urine routine;Blood routine;kidney function;liver function;12-lead ECG;vital signs;