Epidemic Viral Influenza
Conditions
Interventions
Treatment group:Jingzhi Niuhuang Jiedu Tablets: Oral administration, 2 tablets per dose, twice daily. Oseltamivir Phosphate Capsules: 75 mg per dose, twice a day
Control group:Oseltamivir Phosphate Capsules: 75 mg per dose, twice a day
Sponsors
Dongfang Hospital of Beijing University of Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1 )Patients meeting the Western diagnostic criteria for "influenza "as outlined in the Influenza Diagnosis and Treatment Guidelines (2020 Edition). (2) Patients with a positive nucleic acid test result for influenza A virus. (3) Patients meeting theTraditional Chinese Medicine (TCM) diagnostic criteria for "exterior cold and interior heat syndrome" (Biao Han Li Re Zheng). (4) Aged 18–65 years, regardless of gender. (5) Axillary temperature >=37.5°C (99.5°F). (6) Symptom duration =48 hours**, with no prior systemic use of other anti-influenza medications. (7) No history of allergy to the study drugs. (8) Voluntary participation with written informed consent, obtained in compliance with Good Clinical Practice (GCP) guidelines.
Exclusion criteria
Exclusion criteria: (1) Patients with severe or critical influenza. (2) Hypersensitivity** to any component of the investigational drug. (3) Uncontrolled severe comorbidities*(cardiovascular, hepatic, renal, endocrine, or hematologic diseases), including: ALT or AST >1.5×ULN (upper limit of normal) Serum creatinine (Cr) >2×ULN. (4) Pregnant or lactating women. (5) Patients with psychiatric disorders or history of alcohol/drug abuse. (6) Patients with spleen-stomach deficiency syndrome (e.g., chronic anorexia, constipation/diarrhea, or abdominal pain). (7) Other conditions that may reduce enrollment feasibility or increase dropout risk (e.g., highly variable work schedules), as judged by investigators. (8) Current participation in other clinical drug trials.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to Complete Fever Resolution After Initial Medication; | — |
Secondary
| Measure | Time frame |
|---|---|
| Symptoms of influenza patients in traditional Chinese medicine;Before treatment and on the third, fifth and seventh days after treatment, the TCM syndrome grading of the influenza patients was evaluated.;Classification of the severity of influenza patients' conditions;Result of influenza virus nucleic acid testing;Time for fever reduction to take effect; | — |
Countries
China
Contacts
Public ContactZhou Tao
Dongfang Hospital of Beijing University of Chinese Medicine
Outcome results
None listed