influenza
Conditions
Interventions
High dose group:Huangzhi Capsules: Take orally 4 capsules at a time 3 times a day (once in the morning noon and evening). Medication course: 5 days.
Ligh dose group:Huangzhi Capsule + Huangzhi Capsule Simulator: Take orally 4 capsules at a time (2 Huangzhi Capsules + 2 Huangzhi Capsule Simulator) 3 times a day (once in the morning noon and evening
Placebo group:Huangzhi Capsule Simulator: Oral 4 capsules at a time 3 times a day (once in the morning noon and evening). Medication course: 5 days.
Sponsors
Guangdong provincial hospital of traditional Chinese medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Candidates must satisfy all inclusion criteria during the screening process to be eligible for participation in the study group: (1) Age range of 18 to 65 years inclusive with no gender restrictions; (2) Adherence to Traditional Chinese Medicine (TCM) syndrome differentiation standards for influenza specifically wind-heat syndrome; (3) Compliance with Western medicine diagnostic criteria for influenza; (4) Duration of illness of 48 hours or less with an axillary body temperature at the time of screening between 37.4°C and 39.0°C; (5) Positive result on the influenza virus antigen test. (6) At least one of the systemic or respiratory symptoms of influenza must be of moderate or greater severity. Systemic symptoms include headache fever sweating muscle aches fatigue and malaise for wind while respiratory symptoms encompass cough thirst sore throat and nasal congestion. (7) Participants must voluntarily agree to partake in this clinical trial and provide written informed consent.
Exclusion criteria
Exclusion criteria: Individuals who meet any of the following exclusion criteria during the screening process will not be admitted: (1) a clinical diagnosis of severe or critical influenza; (2) a total white blood cell count exceeding 10.0×10^9/L a neutrophil percentage greater than 80% or the presence of purulent sputum indicative of a suspected bacterial infection; (3) a history of respiratory tract infection within the past month including conditions such as rhinitis sinusitis tracheobronchitis or pneumonia;(4) Presence of severe or unmanageable underlying medical conditions: chronic respiratory diseases (e.g. chronic obstructive pulmonary disease [COPD] bronchial asthma) cardiovascular diseases (e.g. congenital heart disease coronary artery disease chronic congestive heart failure electrocardiogram indicating QTc prolongation [QTcF > 450 ms for men QTcF > 470 ms for women] myocarditis excluding hypertension with stable blood pressure control) renal disease (e.g. serum creatinine levels exceeding the upper limit of normal) hepatic insufficiency (characterized by ALT or AST levels = 3 times the upper limit of normal [ULN] or total bilirubin levels = 5 times the ULN) hematologic disorders neurological and neuromuscular diseases metabolic and endocrine disorders (such as diabetes) immunosuppressive conditions (including the use of immunosuppressants) or HIV infection which result in compromised immune function and malignant tumors; (5) A body mass index (BMI) greater than 30 kg/m² or less than or equal to 16 kg/m² [BMI = weight (kg)/height (m)²]; (6) Prior to randomization during the course of this disease the patient who have undergone antiviral drug treatment which may include but is not limited to oseltamivir zanamivir peramivir rimantadine amantadine and arbidol; (7) Patient have received an influenza vaccine within the past six months; (8) Patient have a history of allergic diseases (such as allergic rhinitis or allergic asthma) or allergies to the test drugs including the ingredients of this product (Scutellaria baicalensis Andrographis paniculata) or a history of allergy to acetaminophen or pharmaceutical excipients; (9) Women who are currently pregnant or intending to conceive within the next three months as well as those who are lactating; (10) Women of childbearing potential who are either unable or unwilling to use effective contraception during the trial or for one month following the final dose or whose partners are unwilling to use contraceptive measures; (11) Individuals who are unable or unwilling to comply with clinical trial protocols due to other medical conditions; (12) Individuals with a suspected or confirmed history of alcohol or substance abuse; (13) Those who have participated in other clinical trials or are currently participating in other drug clinical trials in the past 3 months (except those who have not taken drugs); (14) Those who the researcher believes are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Influenza clinical symptom relief time; | — |
Secondary
| Measure | Time frame |
|---|---|
| Influenza clinical symptoms recovery time and recovery rate;Curative effect of traditional Chinese medicine syndrome;Antipyretic onset time;Acetaminophen tablets medication;Disappearance time of single influenza clinical symptoms; | — |
Countries
China
Contacts
Public ContactDing Banghan
Guangdong provincial hospital of traditional Chinese medicine
Outcome results
None listed