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Clinical study of Lian Bizhi injection in the treatment of adult community-acquired pneumonia

A randomized, double-blind, placebo-controlled, multi-center clinical trial on the effectiveness and safety of Lian Bizhi injection in the treatment of adult community-acquired pneumonia (phlegm-heat obstructing lung syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2000003510
Enrollment
Unknown
Registered
2020-07-24
Start date
2018-07-09
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

community-aquired pneumonia

Interventions

Sponsors

China-Japan Friendship Hospital
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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.

Exclusion criteria

Exclusion criteria: 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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
Medical examination;Urine routine;Blood routine;kidney function;liver function;12-lead ECG;vital signs;

Countries

China

Contacts

Public ContactZhang Hongchun

China-Japan Friendship Hospital

13701226664@139.com+86 13701226664

Outcome results

None listed

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