acute pharyngitiss
Conditions
Interventions
Experimental group: Guilin Xiguashuang+Yiqing Capsule Analog:Guilin Xiguashuang:For external use, spray 3 times per application, 6 times a day
Positive control group: Yiqing Capsules+ Guilin Xiguashuang Analog,:Guilin Xiguashuang Analog:For external use, spray 3 times per application, 6 times a day
Yiqing Capsule : For oral administration, take 2 capsules at a time, 3 times a day.5 days for treatment.
Sponsors
Shanghai Hospital of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: The following criteria must be fully met for inclusion in the trial: (1) Meet the Western medicine diagnostic criteria for acute pharyngitis; (2) TCM (Traditional Chinese Medicine) syndrome differentiation indicates heat excess in the lung and stomach; (3) Duration of illness is within 48 hours at the time of enrollment (the time from the appearance of acute pharyngitis symptoms such as sore throat and redness/swelling of the throat to enrollment is within 48 hours); (4) Axillary body temperature at screening = 38.5°C; (5) Sore throat NRS (Numeric Rating Scale) score = 4 at screening; (6) Age between 18 and 65 years old (including 18 and 65), gender not limited; (7) Voluntarily participate in this clinical trial, with informed consent and signed informed consent form.
Exclusion criteria
Exclusion criteria: 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.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of disappearance of throat pain on the 6th day of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The rate of disappearance of throat pain on the 4th day of treatment.;The time of throat pain resolution.;Therapeutic Effectiveness on TCM Syndromes;The average change in NRS score for throat pain from baseline during days 1 to 5 of treatment.;Change in Score of Individual TCM Syndrome Symptoms from Baseline.;Emergency Medication Usage Situation;The onset time of analgesia; | — |
Countries
China
Contacts
Public ContactGuo Yu
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed