acute tonsillitis
Conditions
Interventions
Experimental group:Guilin Xiguashuang:For external use, spray 3 times per application, 6 times a day
Positive control group:Yiqing Capsule : For oral administration, take 2 capsules at a time, 3 times a day,Guilin Xiguashuang Analog:For external use, spray 3 times per application, 6 times a day.5 day
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 met in full to be eligible for inclusion in the trial: (1) Meets the Western medical diagnostic criteria for acute tonsillitis; (2) According to Traditional Chinese Medicine syndrome differentiation, diagnosed with a syndrome of excess heat in the lung and stomach; (3) Duration of illness is within 48 hours upon enrollment (the time from the appearance of acute tonsillitis symptoms such as throat pain and tonsil redness and swelling to enrollment is within 48 hours); (4) Axillary body temperature is =38.5°C upon screening; (5) NRS (Numeric Rating Scale) score for throat pain is =4 upon screening; (6) Age is between 18 and 65 years old (inclusive of 18 and 65), gender is not limited; (7) Volunteers to participate in this clinical trial, understands the informed consent and signs the informed consent form.
Exclusion criteria
Exclusion criteria: Subjects meeting any of the following criteria will not be eligible to participate in this study: (1) Subjects with concurrent lower respiratory tract diseases (such as pneumonia, acute bronchitis, bronchiectasis), or throat symptoms or inflammation caused by diseases like suppurative tonsillitis, measles, scarlet fever, diphtheria, tuberculous ulcer of the pharynx, agranulocytosis, infectious mononucleosis, leukemia, acute carotid arteritis, tonsillar tumor, etc.; (2) Subjects with white blood cell count and absolute neutrophil count exceeding 1.2 times the upper limit of normal (ULN), and the investigator considers them to be bacterial infections; (3) Subjects who have used any traditional Chinese or Western medicine for treating acute tonsillitis during the current illness episode, including drugs for relieving throat pain (such as traditional Chinese medicine preparations, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.); (4) Subjects who need to take warming and tonifying traditional Chinese medicine concurrently during the medication period; (5) Subjects with liver function ALT, AST exceeding 1.5 times the upper limit of normal reference values or Scr exceeding the upper limit of normal reference values; (6) Subjects with 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.; (7) Subjects who are allergic to the investigational drugs (including the positive control drug and emergency drugs) or their ingredients, excipients; (8) Pregnant or planning to become pregnant women, lactating women, fertile patients unable or unwilling to take adequate contraceptive measures during the trial, or their spouses unwilling to take contraceptive measures; (9) Subjects suspected or confirmed of having alcohol dependence or a history of drug abuse; (10) Subjects with intellectual disabilities or mental disorders; (11) Subjects who have participated or are currently participating in other drug or medical device clinical trials within one month; (12) Subjects deemed ineligible for participation in this study by the investigators.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The rate of disappearance of throat pain on the 6th day of treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| The onset time of analgesia;Therapeutic Effectiveness on TCM Syndromes;Change in Score of Individual TCM Syndrome Symptoms from Baseline.;The time of throat pain resolution.;Emergency Medication Usage Situation;The rate of disappearance of throat pain on the 4th day of treatment.;The average change in NRS score for throat pain from baseline during days 1 to 5 of treatment.; | — |
Countries
China
Contacts
Public ContactGuo Yu
Shanghai Hospital of Traditional Chinese Medicine
Outcome results
None listed