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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
ChiCTR
Registry ID
ChiCTR2100050245
Enrollment
Unknown
Registered
2021-08-24
Start date
2021-09-20
Completion date
Unknown
Last updated
2022-04-25

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

Conditions

viral pnetlmonia

Interventions

experimental group:Clinical routine treatment + reduning injection

Sponsors

The First Affiliated Hospital of Guangzhou Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 80 Years

Inclusion criteria

Inclusion criteria: 1. 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 37.3?); (2) Recent cough, expectoration or exacerbation of existing respiratory symptoms, with or without purulent sputum/chest pain/dyspnea/hemoptysis; (3) 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. Aged from 18 to 80 years, 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: (1) Main criteria: 1) The need for endotracheal intubation and mechanical ventilation; 2) Septic shock still needs vasoactive drug therapy after active fluid resuscitation; (2) Minor criteria: 1) Respiratory rate >=30 times/min; 2) Oxygenation index =7.14mmol/L; 6) Systolic pressure <90 mmHg requires active fluid resuscitation; 4. The subject was positive for novel coronavirus nucleic acid test; 5. Complicated with heart, liver, kidney, digestive system, blood system and other serious diseases; 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 ;

Secondary

MeasureTime frame
Time to return to normal in febrile patients;The change value of inflammatory cytokines;Viral nucleic acid negative rate;Secondary bacterial infection rate;Intensive care unit transfer rate;Temperature recovery rate of febrile patients;The disappearance rate and time of individual clinical symptoms;Changes in all clinical symptom scores;Chest imaging changes;Length of stay and remission of clinical symptoms;Remission rate of clinical symptoms;

Countries

China

Contacts

Public ContactYe Feng

The First Affiliated Hospital of Guangzhou Medical University

yefeng@gird.cn+86 18928868221

Outcome results

None listed

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