Acute upper respiratory tract infection
Conditions
Interventions
Experimental group:Prodilan anti-inflammatory oral solution
Control group:Capsule with Prodilan oral solution
Sponsors
China Japan Friendship Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of "wind and fever offender certificate": 2 or more of the following symptoms appear: headache or general muscle aches; Sore throat; yellow purulent or viscous rhinorrhea; Red tongue (reference provided). and exclude all of the following symptoms : feeling cold or feeling cold and runny nose after feeling afraid of cold or adding clothing; (2) Refer to the "Guidelines for Primary Diagnosis and Treatment of Acute Upper Respiratory Tract Infection (2018)", which is in line with the clinical diagnosis of "acute upper respiratory tract infection"; (3) Within 48 hours of onset (4) Armpit body temperature= 37.3 °C (5) Age 18~70 years old (including 18 and 70 years old) (6) Voluntarily participate in this clinical trial and sign a written informed consent form
Exclusion criteria
Exclusion criteria: (1) Combined with lower respiratory tract infection; (2) Known history of the following: chronic respiratory diseases combined with respiratory failure, cardiovascular and cerebrovascular diseases (congenital heart disease, chronic heart failure, coronary artery disease or stroke; uncontrolled hypertension, excluding uncomplicated hypertension; acute stroke), advanced cancer, severe liver damage (child Pugh class C cirrhosis), uremia, diabetic ketosis, hyperthyroid crisis, thyroid storm, immunosuppression (including disease or medication that weakens the immune system, such as those who use systemic steroids for a long time and those with human immunodeficiency virus [HIV] infection); Hepatitis C antiviral therapy is known to exist or for chronic hepatitis C virus infection. (3) BMI greater than 35 [BMI = weight (kg) / height (m)2] (4) Women and men who are pregnant or plan to become pregnant within the next 3 months; lactating women; Women of childbearing age or their spouses who are unable or unwilling to use adequate contraception during the trial or within 1 month of the last dose; (5) Allergy to the test drug or its components; (6) Within 12 hours before enrollment, they have received Chinese medicine or proprietary Chinese medicine treatment containing the following contents in the functional treatment of the instruction manual: (1) Relieve wind, disperse cold, clear heat, detoxify, detoxify, detoxify, promote lungs, cough, sharpen throat, reduce swelling, remove dampness, general knowledge, and relieve pain (2) Chinese medicine or proprietary Chinese medicine for the treatment of respiratory diseases such as upper respiratory tract infections, colds, mumps, pharyngitis, tonsillitis and other respiratory diseases (such as cold and heat clearing particles, lianhua clear plague particles, wind chill cold particles, nasturtium capsules, etc.); (7) Have received antiviral drugs (such as oseltamivir, amantadine, amantadine, arbidol, ribavirin, acyclovir, etc.) before enrollment; (8) Have participated in other clinical trials or are participating in other drug clinical trials within the past 3 months; (9) Patients considered by other investigators to be unsuitable for enrollment;
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom resolution time; | — |
Secondary
| Measure | Time frame |
|---|---|
| The time when the body temperature returns to normal;Drug safety;Time to improvement of individual symptoms;Pulmonary complication rate;Antimicrobial use rate after enrollment;All-cause hospitalization rate;Acetaminophen tablets consumption.; | — |
Countries
China
Contacts
Public ContactCao Bin
Outcome results
None listed