Influenza (Syndrome of dampness toxin invading lung)
Conditions
Interventions
Treatment group:Huashi Baidu granules
Control group:Huashi Baidu granule mimic agent
Sponsors
China-Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Age of 18 to 65 years old (including boundary value) regardless of gender; (2) meet the diagnostic criteria of influenza in western medicine; (3) Conforming to the TCM syndrome criteria of dampness toxin invading the lung; (4) have an epidemiological history with at least one systemic or respiratory symptom within 48 hours; (5) axillary temperature =37.5?; (6) understand and abide by the study process voluntarily participate in and sign the informed consent.
Exclusion criteria
Exclusion criteria: (1) The diagnosis of severe or critical influenza according to the "Influenza Diagnosis and Treatment Plan (2025 version)"; (2) diagnosed with pharyngeal junctional membrane fever herpangina suppurative tonsillitis or 2019-ncov infection; (3) Tracheitis bronchitis pneumonia pleural effusion interstitial lesions and other diseases confirmed by chest imaging (chest X-ray or CT); (4) The white blood cell count and absolute neutrophil count were more than 1.2 times ULN and the investigator considered bacterial infection; (5) patients with a history of epilepsy and febrile convulsions; (6) Allergic to the ingredients of the test drug Huashibaidu granule or allergic constitution (including: no less than 2 drug allergic reactions in the past 2 years or allergic history of 2 or more drugs or foods or family allergic history); (7) accompanied by life-threatening or significantly affecting the ability to perform daily activities of serious diseases or basic diseases that cannot be clinically stable after standard treatment and which have an impact on the efficacy of the study or the safety of the study as judged by the investigators: Such as blood diseases chronic respiratory diseases (such as chronic obstructive pulmonary disease bronchial asthma) hepatic insufficiency (ALT or AST=3ULN Total bilirubin =1.5ULN) renal insufficiency (serum creatinine =1.2 times the upper limit of normal) cardiovascular diseases (such as congenital heart disease coronary heart disease chronic congestive heart failure electrocardiogram showed QTc prolongation (QTcF > 450ms in men and QTcF > 470ms in women except for complete right bundle branch block) Except hypertension without any cardiovascular symptoms] nervous system and neuromuscular diseases metabolic and endocrine system diseases mental diseases etc. (8) patients with known immunodeficiency such as uncured or active malignant tumors organ or bone marrow transplantation HIV infection or taking immunosuppressants in the past 3 months; (9) patients with fava disease; (10) patients diagnosed with acute respiratory infection otitis media or sinusitis within one week before screening; (11) patients who had taken anti-influenza drugs (oseltamivir zanamivir peramivir favipiravir abidol amantadine or rimantadine etc.) or Chinese patent medicine with anti-influenza virus components or efficacy within 48 hours before enrollment and the evaluation by the investigator had an impact on the evaluation of efficacy; (12) vaccinated with influenza virus vaccine within 6 months before enrollment; (13) not applicable to ephedra or Chinese medicine formula or patent medicine preparation containing ephedra; (14) patients with other diseases requiring treatment with aspirin or salicylate; (15) pregnant lactating women or those with a positive pregnancy test (no pregnancy test for sterilized or postmenopausal women); (16) participants who had participated in other interventional clinical trials within 1 month before enrollment and used the intervention treatment group; (17) Other conditions considered by the investigator to be inappropriate for participation in the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Time to complete defervescence;The incidence of influenza-related complications (complicated with sinusitis, complicated with bronchitis, complicated with otitis media, complicated with pneumonia), hospitalization rate, and mortality rate.;Antipyretic onset time;TCM syndrome curative effect;Change from baseline in the total score of seven influenza symptoms;Time to sustained relief of major symptoms (fever, muscle soreness, headache, cough);Changes in TCM syndrome scores from baseline;Proportion of study participants with remission of seven influenza symptoms (fever or chills, headache, muscle or joint pain, fatigue, nasal congestion or runny nose, sore throat, and cough);Proportion of study participants who became negative for influenza nucleic acid after 5 days of dosing;The disappearance rate of single TCM syndrome;The time to achieve sustained remission of a single influenza symptom;Doses and rates of use of acetaminophen and antibiotics; | — |
Countries
China
Contacts
Public ContactJiangtao Lin
China-Japan Friendship Hospital
Outcome results
None listed