Viral pneumonia
Conditions
Interventions
Experimental Group:Routine clinical treatment + Fuzheng Jiedu formula 20g per dose, twice daily.
Control Group:Routine clinical treatment plus Simulating agent for Fuzheng Jiedu decoction, 20g per dose, twice daily.
Sponsors
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for pneumonia as specified in the *Chinese Adult Community-Acquired Pneumonia Diagnosis and Treatment Guidelines (2016 Edition)* issued by the Respiratory Medicine Branch of the Chinese Medical Association; (2) Meet the syndrome differentiation criteria for the heat-toxin obstructing the lung type of wind-warmth warm-lung disease in traditional Chinese medicine, as specified in the *Traditional Chinese Medicine Internal Medicine Disease Diagnosis and Efficacy Standards (ZY/T001.1-94)*, the *Community-Acquired Pneumonia Traditional Chinese Medicine Diagnosis and Treatment Guidelines (2018 Revised Edition)*, and the Influenza Diagnosis and Treatment Plan (2020); (3) Community onset, with chest imaging showing new patchy infiltrates, lobar or segmental consolidation, ground-glass opacities, or interstitial changes, with or without pleural effusion; (4) Peripheral blood white blood cell count is approximately normal or low (below the lower limit of normal); (5) Acute onset (duration =7 days), with one or more pneumonia-related clinical manifestations: fever (axillary temperature >37.3°C); newly developed cough, sputum production, or worsening of original respiratory disease symptoms, with or without purulent sputum/chest pain/dyspnea/hemoptysis; signs of lung consolidation and/or audible wet rales; (6) PSI score of II–IV; (7) Pathogen testing confirms viral infection (including influenza virus, parainfluenza virus, rhinovirus, adenovirus, SARS-CoV-2, human metapneumovirus, respiratory syncytial virus, etc., with any positive pathogen test result); (8) Age 18–80 years, regardless of gender; (9) Subjects voluntarily participate in this study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Patients with a clear diagnosis of other respiratory diseases such as acute exacerbation of chronic bronchitis, bronchiectasis, pulmonary tuberculosis, or severe interstitial lung disease; patients with a clear diagnosis of bronchial asthma requiring hormone therapy; (2) Use of Chinese patent medicines or herbal formulas whose instructions explicitly indicate functions of heat-clearing, epidemic-clearing, detoxification, relieving exterior symptoms, antiviral effects, or strengthening vital qi to eliminate pathogens within 24 hours before screening; (3) Referencing the diagnostic criteria for severe pneumonia in the *Chinese Adult Community-Acquired Pneumonia Diagnosis and Treatment Guidelines (2016 Edition)*, those meeting one of the following major criteria or =3 minor criteria: a. Major criteria: 1) Requiring tracheal intubation for mechanical ventilation; 2) Septic shock requiring vasoactive drugs even after active fluid resuscitation. b. Minor criteria: 1) Respiratory rate =30 breaths/min; 2) Oxygenation index =250 mmHg (1 mmHg = 0.133 kPa); 3) Multilobar infiltrates; 4) Disturbance of consciousness and/or disorientation; 5) Blood urea nitrogen =7.14 mmol/L; 6) Systolic blood pressure 1000 meters), PaO2/FiO2 should be corrected using the formula: PaO2/FiO2 × [760/atmospheric pressure (mmHg)]; 4) Progressive worsening of clinical symptoms, with chest imaging showing significant lesion progression >50% within 24-48 hours. b. Critical illness diagnostic criteria: Meeting any of the following: 1) Respiratory failure requiring mechanical ventilation; 2) Shock; 3) Combined failure of other organs requiring ICU monitoring and treatment. (5) Complicated by severe diseases of the heart, liver, kidneys, digestive system, hematopoietic system, etc., for example: Malignant tumors (excluding adequately treated and completely cured basal cell carcinoma or squamous cell carcinoma of the skin, or carcinoma in situ of the cervix); Acute hepatitis; Aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 2 times the upper limit of normal, or total bilirubin > 2 times the upper limit of normal; AST or ALT > 2 times the upper limit of normal and total bilirubin > 1.5 times the upper limit of normal; History of liver cirrhosis; Clinical manifestations of end-stage liver disease, such as ascites or hepatic encephalopathy; Neutropenia (neutrophils < 0.5 × 10^9/L); Thrombocytopenia (platelets < 50 × 10^9/L); Coagulation disorders like hemophilia; NYHA cardiac function classification = Grade III; Chronic kidney disease stage = 3; (6) Known allergy to any component of the study drug; (7) Participation in other drug clinical trials within 3 months prior to screening; (8) Women who are breastfeeding, pregnant, or women of childbearing age planning pregnancy within 6 months after screening, or those with a positive urine pregnancy test, or
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| On the day of discontinuation of medication, the overall relief rate of primary clinical symptoms (fever, cough, expectoration, muscle pain, shortness of breath).;The main clinical symptoms (including fever, cough, expectoration, muscle pain, and shortness of breath) and the overall relief time (the time it takes to achieve clinical symptom relief after treatment).; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to return to normal body temperature (after treatment, body temperature drops below 37.3? and remains below this level for at least 24 hours).;fever patients' temperature recovery rate (after treatment, temperature drops below 37.3? and is maintained for at least 24 hours, the proportion of patients);Overall remission rate of major clinical symptoms;Time to complete resolution of primary clinical symptoms (the time after treatment when primary clinical symptoms are completely resolved);Clinical symptom relief rate;The disappearance rate and disappearance time of individual clinical symptoms.;The change values of all clinical symptom scores.;Improvement in Traditional Chinese Medicine (TCM) Syndrome Scale Scoring;Thoracic imaging changes (showing the proportion of complete or partial absorption);The change values of inflammatory cytokines compared to baseline.;The change in values of lymphocyte subsets compared to baseline.;Hospitalization Duration;Viral nucleic acid negative conversion rate;Secondary bacterial infection rate;Use of antimicrobial agents, hormones, antipyretics, and other combined medications.;Conversion to severe cases rate; | — |
Countries
China
Contacts
Public ContactJihong Feng
The Second Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
Outcome results
None listed