Acute pharyngitis, acute tonsillitis, acute onset of chronic pharyngitis and other bacterial upper respiratory tract infections caused by sore throat and other uncomfortable symptoms
Conditions
Interventions
Group A:Dequalinium Chloride Buccal Tablets + cefaclor simulated capsules
Group B:Dequalinium Chloride Buccal simulated Tablets + cefaclor capsules
Group C:Dequalinium Chloride Buccal Tablets + cefaclor capsules
Sponsors
Tianjin Fifth Central Hospital
Eligibility
Sex/Gender
All
Age
18 Years to No maximum
Inclusion criteria
Inclusion criteria: (1) age >=18 years old, both sexes; (2) Voluntarily participated in this study, strictly followed the doctor's advice, actively cooperated with the treatment, understood and signed the informed consent. (3) meet the discomfort symptoms such as sore throat caused by bacterial upper respiratory tract infection such as acute pharyngitis, acute tonsillitis, acute onset of chronic pharyngitis and other related ethical requirements; (4) The VAS score of the first recent onset of sore throat (odynophagia) within 48 hours after onset was >=40 mm; (5) meet the requirements of any of the following laboratory test indicators: white blood cell count >=10*10^9/L; The percentage of neutrophils >= 75%; C-reactive protein >=50mg/L. (6) In order to avoid affecting the collection of throat swab samples, subjects are willing to refrain from eating or drinking (e.g., not smoking, not eating food, not drinking beverages, not eating candy, not eating lozenges, not chewing gum) except for the test drug for one hour after the first dose of the test drug, including inhalation therapy. (7) negative urine pregnancy in women of childbearing age; (8) those who had no childbearing plan within 3 months after the end of the trial and agreed to use effective non-pharmacological contraceptive methods during the trial.
Exclusion criteria
Exclusion criteria: (1) Allergic constitution, with a history of drug or food allergy, with a history of cephalosporins or penicillin antibiotics allergy, allergic to diquinolone chloride and any component in the excipients; (2) pure viral upper respiratory tract infection as diagnosed by the investigator; (3) those who had a history of drinking within 7 days before the trial and could not guarantee abstinence during the trial; (4) use of analgesics within 12 hours before or during the study; (5) use of antibiotics within 48 hours before or during the study; (6) In addition to the study drug, topical treatment (sprays, mouthwashes, lozenges) for pharyngeal use within 12 hours before study initiation or treatment cannot be cancelled; (7) Pharyngeal symptoms or inflammation caused by diseases such as measles, scarlet fever, influenza, infectious mononucleosis, agranulocytosis, leukemia, diphtheria, and Farzenian angina were excluded; (8) use of systemic or inhaled corticosteroids within 1 month (inclusive) before the study, with planned treatment (other than skin medication) during the study; (9) disorders of bronchial and ciliary motility or diseases associated with relatively large amounts of secretions (risk of blockage of secretions); Use of any "cold medicine" (i.e., decongestants, antihistamines, expectorants, antitussive) within 4 hours before taking the dose of the study drug; (11) subjects with smoking history (average number of cigarettes per day >=5) within 12 months before screening; (12) patients with a history of cardiovascular, hepatic, renal, pulmonary, gastrointestinal, neurological, autoimmune, metabolic, musculoskeletal, or hematopoietic diseases; However, benign diseases (such as hepatic cysts, renal cysts, fatty liver, etc.) found by chest X-ray and color Doppler ultrasound that do not need treatment were excluded. (13) participants who participated in clinical trials of other drugs within 3 months before screening; (14) those with blood loss or blood donation >=400mL within 8 weeks before screening, except women during menstrual period; (15) women in pregnancy, lactation or recent childbearing planning; (16) Persons deemed by the investigators to be ineligible for the trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| VAS score for sore throat/odynophagia;Onset time and duration of pharyngalgia or odynophagia;Efficacy of individual symptoms and signs (Percentage effective); | — |
Secondary
| Measure | Time frame |
|---|---|
| Determination OF BACTERIAL FLORA; | — |
Countries
China
Contacts
Public ContactShaoxiang Huang
Tianjin Fifth Central Hospital
Outcome results
None listed