Acute Pharyngitis
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1)Aged between 18 and 65 years old (inclusive) regardless of gender; (2)Meeting the diagnostic criteria for Western medicine acute pharyngitis and the syndrome differentiation criteria for lung-stomach excess heat syndrome in traditional Chinese medicine; (3)Disease duration = 48 hours at screening; (4)Pharyngeal pain VAS score = 4 points; (5)The research participants have been informed voluntarily signed the informed consent form and agreed to attend all visits examinations and treatments as required by the trial protocol.
Exclusion criteria
Exclusion criteria: (1)Subjects with body temperature >38.5°C or blood routine examination showing white blood cell count and absolute neutrophil count > upper limit of normal reference value (ULN); (2)Subjects complicated with respiratory diseases such as suppurative tonsillitis pneumonia bronchitis otitis media laryngitis herpetic angina etc.; (3)Subjects with pharyngeal symptoms or inflammation caused by measles influenza pharyngeal diphtheria Vincent angina and certain blood diseases (mononucleotic angina agranulocytic angina leukemic angina scarlet fever) etc.; (4)Subjects with severe primary diseases of the heart cerebrovascular system lungs liver kidneys or hematopoietic system and abnormal liver or kidney function (specifically aspartate aminotransferase (AST) and alanine aminotransferase (ALT) >1.5×ULN serum creatinine (Scr) >ULN); (5)Subjects with malignant tumors; (6)Subjects with a documented history of neurological or psychiatric disorders or those judged by the investigator to be unable to cooperate with treatment or follow medical advice; (7)Subjects who have used other Chinese or Western medications for the treatment of this disease (except for the study's emergency medications) within 48 hours prior to screening or who need to take antibiotics or heat-clearing and detoxifying drugs for other diseases; (8)Pregnant women women intending to become pregnant or lactating women; (9)Subjects with allergies to the study drugs or their components or to the study's emergency medications or their components; (10)Subjects who have participated in other drug clinical trials within the past 3 months or medical device clinical trials within the past 1 month; (11)Subjects with a history of chronic alcoholism or drug abuse poor compliance during the screening period or any factors affecting compliance; (12)Subjects whom the investigator deems unsuitable to participate in this clinical trial for other reasons.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The change value of the VAS score for sore throat after 5 days of treatment compared with the baseline; | — |
Secondary
| Measure | Time frame |
|---|---|
| Time to onset and duration of effect of sore throat relief;Therapeutic effects of traditional Chinese medicine on symptoms after 3 days and 5 days of treatment; main symptoms and secondary symptoms' therapeutic effects (total effective rate significant improvement rate);Changes in TCM syndrome scores at 3 days and 5 days of treatment compared to the baseline as well as the change rates;Usage of emergency medication (acetaminophen) for 5 days of treatment (frequency of use proportion of study participants who used it);The total effective rate and cure rate of individual symptoms (dry and burning sensation in the throat fever general body aches thirst and excessive drinking cough thick and sticky phlegm) and the therapeutic effect of pharyngeal signs (pharyngeal mucosa congestion and edema) after 3 days and 5 days of treatment;Time for sore throat to disappear;The recovery rate and total effective rate of sore throat after 3 days and 5 days of treatment;;The change values and rates of the VAS score for sore throat after 3 days of treatment compared to the baseline; the rate of change of the VAS score for sore throat after 5 days of treatment compared to the baseline;The therapeutic effects (total effective rate and marked effective rate) of 3-day and 5-day treatment for diseases; | — |
Countries
china
Contacts
China-Japan Friendship Hospital