Acute Pharyngitis (Bacterial Infection)
Conditions
Interventions
Test Group :Luohuazizhu Granules (1 sachet per dose three times daily) + Bairui Granules Matching Placebo (1 sachet per dose three times daily)
Control Group:Luohuazizhu Granules Matching Placebo (1 sachet per dose three times daily) + Bairui Granules (1 sachet per dose three times daily)
Sponsors
Xiyuan Hospital China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1.Aged 18 to 65 years (inclusive) any gender. 2.Meets the diagnostic criteria for acute pharyngitis. 3.Time since onset of clinical symptoms/signs at screening is = 48 hours. 4.Throat pain VAS score at screening is = 4. 5.Laboratory results suggestive of bacterial infection (elevated white blood cell count OR elevated neutrophil count/percentage OR elevated C-reactive protein level). 6.Conscious oriented voluntarily consents to participate and commit to the treatment and is able to cooperate with examinations and adhere to the treatment regimen.
Exclusion criteria
Exclusion criteria: 1.Patients with concurrent suppurative tonsillitis pneumonia otitis media laryngitis or herpangina. 2.Patients presenting with pharyngeal symptoms or inflammation caused by concurrent conditions such as measles influenza pharyngeal diphtheria Vincent's angina scarlet fever or certain hematological disorders (monocytic angina agranulocytic angina leukemic angina). 3.Body temperature > 38.0°C at screening. 4.Known allergy/hypersensitivity to any component of the investigational product. 5.Women who are pregnant or breastfeeding; participants of childbearing potential (including male participants with female partners of childbearing potential unwilling to use highly effective contraception) planning pregnancy or unwilling to use highly effective contraception from screening until 1 month after discontinuation of the study drug. 6.Patients with concurrent severe primary diseases of the cardiovascular cerebrovascular pulmonary renal digestive or hematopoietic systems. 7.Patients with abnormal liver or kidney function (specifically aspartate aminotransferase (AST) or alanine aminotransferase (ALT) > 1.5 times the upper limit of normal (ULN) or serum creatinine (Scr) > ULN) AND deemed by the investigator to require further clinical assessment. 8.Patients with concurrent thrombotic diseases (e.g. deep vein thrombosis pulmonary embolism cerebral infarction) or those with coagulation tests indicating a hypercoagulable state. 9.Patients with a history of alcohol abuse and/or use of psychoactive substances or those with drug abuse or dependence. 10.Patients who have used within 48 hours prior to screening or are anticipated to require during the study period other Western medications (excluding rescue medication defined in this study) Chinese herbal medicines proprietary Chinese medicines decoction pieces or non-pharmacological treatments (including but not limited to acupuncture moxibustion scraping physical therapy etc.) for acute pharyngitis or any treatments deemed by the investigator to potentially interfere with the efficacy evaluation of this study. 11.Patients who have participated in any other clinical trial within 3 months prior to enrollment. 12.Any other condition considered by the investigator to make the patient unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Onset Time for Sore Throat Relief; | — |
Secondary
| Measure | Time frame |
|---|---|
| Pharyngeal Signs Normalization Rate at Day 5 of Treatment (Clinician-Assessed);Investigator-Assessed Incidence of Acute Pharyngitis Complications During the Study Period (Reported as number of patients with events and total event occurrences);Rescue Medication Usage During the Study Period (Including: number of patients treatment courses mean consumption per patient and mean duration of use);Time to Sore Throat Resolution (hours);Change from Baseline in CRP WBC Count and Neutrophil Percentage at Day 5 of Treatment;Change and Percentage Change from Baseline in Sore Throat VAS Score at Day 3 and Day 5 of Treatment;Sore Throat Resolution Rate at Day 3 and Day 5 of Treatment; | — |
Countries
China
Contacts
Public ContactMiao qing
Xiyuan Hospital China Academy of Chinese Medical Sciences
Outcome results
None listed