Objectives of Study:
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A clinical trial evaluating the effectiveness, safety, and clinical advantages of Guilin Xiguashuang in treating acute pharyngitis (Heat Syndrome In The Lung And Stomachh) in adults, using Yiqing Capsule as the positive control drug, to provide evidence for the application of this product for protection of traditional Chinese medicine varieties.
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Exclusion criteria:
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Subjects meeting any of the following criteria will not be eligible to participate in this study:
(1) Chronic pharyngitis;
(2) Concurrent lower respiratory tract diseases (such as pneumonia, acute bronchitis, bronchiectasis), or pharyngeal symptoms or inflammation caused by suppurative tonsillitis, measles, scarlet fever, diphtheria, tuberculous pharyngeal ulcer, agranulocytosis, infectious mononucleosis, leukemia, acute carotid arteritis, tonsillar tumors, etc.;
(3) Blood white cell count and absolute neutrophil count exceeding 1.2 times the upper limit of normal reference values (ULN), and the investigator considers it as bacterial infection;
(4) Use of any Chinese or Western medicine for the treatment of acute pharyngitis within the current illness duration, including sore throat relief medications (such as traditional Chinese medicine preparations, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.);
(5) Need to take warming and nourishing traditional Chinese medicine concurrently during the medication period;
(6) ALT and AST liver function values exceeding 1.5 times the upper limit of normal reference values, or Scr exceeding the upper limit of normal reference values;
(7) Concurrent severe diseases of major organs or systems such as the heart, brain, liver, kidneys, respiratory system, and blood system, including acute myocardial infarction, acute cerebral infarction, viral hepatitis, hemophilia, etc.;
(8) Allergy to the trial medications (including positive control drugs and emergency medications) or their ingredients, excipients;
(9) Pregnant or planning to become pregnant women, lactating women, fertile patients who cannot or are unwilling to take adequate contraceptive measures during the trial, or whose spouses are unwilling to take contraceptive measures;
(10) Suspected or confirmed alcohol dependence, history of drug abuse;
(11) Intellectual disability or mental disorder;
(12) Participating or participating in another drug or medical device clinical trial within one month;
(13) Considered unsuitable for participation in this study by the investigator.
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