Influenza
Conditions
Interventions
Treatment group:Chaige Qingsan granules + Oseltamivir phosphate capsule mimetic agent
Control group:Oseltamivir phosphate capsule + Chaige Qingsan granules mimetic agent
Sponsors
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria for influenza. (2) Meet the diagnostic criteria for Exterior Cold–Interior Heat Syndrome according to traditional Chinese medicine (TCM). (3) Aged 18–65 years, with no restriction on sex. (4) Body temperature = 37.3°C at the time of enrollment. (5) Onset of symptoms within 48 hours before randomization. (6) Voluntarily participate in this clinical study, have full understanding of the study procedures, and provide written informed consent.
Exclusion criteria
Exclusion criteria: (1)Participants presenting with influenza-related complications at screening, including bronchitis, pneumonia, neurologic injury, cardiac injury, myositis, or rhabdomyolysis. (2)Patients with severe influenza requiring hospitalization. (3)Participants with an atopic constitution or known hypersensitivity to any component of the investigational product or its excipients. (4)Participants with dysphagia; or with an indwelling nasogastric or jejunal tube; or with a history of gastrointestinal diseases that markedly affect drug absorption (including but not limited to inflammatory bowel disease, intestinal tuberculosis, gastrinoma, short bowel syndrome, or status after subtotal gastrectomy). (5)Use of anti-influenza antiviral agents or medications or Chinese herbal preparations intended to relieve respiratory symptoms within 12 hours prior to enrollment. (6)During screening, leukocyte count above the upper limit of normal (ULN), or neutrophils >80%, or presence of purulent sputum suggesting bacterial infection requiring systemic antibiotic therapy. (7)Alanine aminotransferase or aspartate aminotransferase =1.5 × ULN, or serum creatinine > ULN at screening. (8)Presence of severe or uncontrolled underlying diseases, including but not limited to: respiratory diseases (e.g., chronic obstructive pulmonary disease, bronchial asthma), hepatic insufficiency, renal insufficiency, cardiovascular diseases (e.g., congenital heart disease, chronic congestive heart failure, myocarditis; excluding hypertension and coronary artery disease without relevant symptoms), hematologic diseases, neurologic or neuromuscular diseases, metabolic or endocrine disorders, or psychiatric disorders. (9)Known immunocompromised status, including malignancies undergoing chemotherapy or radiotherapy, organ or bone marrow transplantation, human immunodeficiency virus (HIV) infection, or treatment with immunosuppressive agents within 3 months prior to enrollment. (10)Suspected or confirmed history of alcohol or drug abuse. (11)Pregnant or lactating women. (12)Participation in another interventional drug clinical trial within 3 months prior to initiation of study treatment. (13)Any other condition that, in the opinion of the investigator, makes the participant unsuitable for inclusion in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to alleviation of influenza symptoms; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to pathogen turning negative;TCM syndrome curative effect;Change in the total score of influenza symptoms;Proportion of subjects with alleviation of symptoms;Time to alleviation of each influenza symptom;Proportion of subjects with alleviation of each influenza symptom;Onset time of fever reduction;Time to resolution of fever;Proportion of subjects with fever resolution;Acetaminophen use rate and dose;Time to return to normal ADLs;Change in European Quality of Life - 5 Dimensions 5 Level Scale (EQ-5D-5L);Incidence of disease aggravation; | — |
Countries
China
Contacts
Public ContactQi Wensheng
Guang'anmen Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed