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A multicenter, randomized, double-blind, placebo-controlled clinical trial of Reduning injection in the treatment of viral pneumonia

A multicenter, randomized, double-blind, placebo-controlled clinical trial was designed to evaluate the efficacy and safety of Reduning injection in the treatment of viral pneumonia

Status
Active, not recruiting
Phases
Early Phase 1
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2100005197
Enrollment
Unknown
Registered
2021-08-24
Start date
2021-09-20
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

viral pnetlmonia

Interventions

treatment group:Clinical routine treatment + reduning injection

Sponsors

The First Affiliated Hospital Of Guangzhou Medical University All Rights Reserved
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: (1) Those who meet the diagnostic criteria of pneumonia in The Guidelines for diagnosis and Treatment of Adult Community-acquired Pneumonia (2016 edition) issued by respiratory Society of Chinese Medical Association; (2) Community onset; (3) New patchy infiltrating shadows, leaf or segmental consolidation shadows, ground glass shadows or interstitial changes, with or without pleural effusion on chest imaging; (4) Procalcitonin (PCT) 37.3?); Recent cough, expectoration or exacerbation of existing respiratory symptoms, with or without purulent sputum/chest pain/dyspnea/hemoptysis; Signs of lung consolidation and/or audible wet rales; (7) PSI grade II-IV; (8) Confirmed to be infected by viruses (including influenza virus, parainfluenza virus, rhinovirus, adenovirus, human metapneumonavirus and respiratory syncytial virus, positive for any of the pathogens); (9) Age 18 ~ 80 years old, gender is not limited; (10) Subjects voluntarily join the study and sign the informed consent.

Exclusion criteria

Exclusion criteria: (1) Patients with definite diagnosis of acute attack of chronic bronchitis, bronchiectasis, tuberculosis, severe pulmonary interstitial lesions and other respiratory diseases; Patients with a definite diagnosis of bronchial asthma requiring hormone therapy; (2) Within 48h before screening, the instructions have been clearly labeled as Chinese patent medicine or Chinese herbal prescription with functions of clearing heat, clearing blast, detoxifying, detoxifying and antiviral; (3) Those who meet the diagnostic criteria of severe pneumonia in The Guidelines for diagnosis and Treatment of Adult Community Acquired Pneumonia in China (2016 edition), that is, those who meet one of the following major criteria or = three minor criteria: A. Main criteria: (1) The need for endotracheal intubation and mechanical ventilation; ? Septic shock still needs vasoactive drug therapy after active fluid resuscitation. B. Minor criteria: ? Respiratory rate =30 times/min; ? Oxygenation index =250mmHg (1mmHg=0133kPa); ? Multiple pulmonary infiltration; (4) Consciousness disorders and/or disorientation; ? Blood urea nitrogen =7.14mmol/L; ? Systolic pressure 3 times upper limit of normal value (ULN), or total bile red > 2 times ULN; AST or ALT > 2 fold ULN and total bilirubin > 1.5 fold ULN; History of cirrhosis; Advanced clinical manifestations of liver disease, such as ascites or hepatic encephalopathy; Neutropenia (neutrophils < 0.5×10^9/L); Thrombocytopenia (platelet < 50×10^9/L); Hemophilia and other coagulation disorders; NYHA cardiac function grade = ?; Chronic kidney disease =3 stage; (6) those who are known to be allergic to the composition of the drug in this study; (7) Those who had participated in clinical trials of other drugs within 3 months before screening; (8) Women who are breastfeeding or pregnant, or women of childbearing age who plan to become pregnant within 6 months after screening test, or those who have positive urine pregnancy test, or male patients who have fertility or sperm donation plan; (9) persons with immunodeficiency or human immunodeficiency virus (HIV) antibody positive (e.g., organ or bone marrow transplants, AIDS patients, persons taking immunosuppressive drugs within 3 months prior to screening); (10) Other conditions that the researcher considers unsuitable to participate in this study

Design outcomes

Primary

MeasureTime frame
Clinical symptom relief rate on the day of discontinuation;

Secondary

MeasureTime frame
The change value of inflammatory cytokines on day 3 and the day of discontinuation of medication;Chest imaging changes on the day of discontinuation;Secondary bacterial infection rate;Length of stay and remission of clinical symptoms;Viral nucleic acid negative rate on the 5th day and the day of stopping medication;Temperature recovery rate of febrile patients on day 3, day 5, and day of discontinuation of medication;Changes in all clinical symptom scores on day 3, day 5, and day of discontinuance;remission rate of clinical symptoms on day 3 and day 5;The disappearance rate and time of individual clinical symptoms on day 3, day 5 and the day of discontinuation of medication;Intensive care unit transfer rate;Time to return to normal in febrile patients;

Countries

China

Contacts

Public ContactFeng Ye

The First Affiliated Hospital Of Guangzhou Medical University All Rights Reserved

yefeng@gird.cn18928868221

Outcome results

None listed

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