💬In plain words
What the trial is, and whether it could suit you
Trial Objectives and Exploration Indicators：
1. To explore the improvement effect of different doses of Qinqiao Yanshu Granules on the symptoms/conditions and TCM syndromes of acute pharyngitis (Wind - Heat Exogenous Syndrome), and its effect on shortening the course of the disease.
2. To observe the safety of the clinical application of Qinqiao Yanshu Granules. Overall Trial Design：A block - randomized, double - blind, dose - escalation, multicenter clinical trial design was adopted.
Sample Size：It is planned to enroll 72 cases in each group (high - dose group, low - dose group, and extremely low - dose group), with a total of 216 cases.
Investigational Products：Experimental groups:
1. High - dose group: Specification: 12g/bag;
2. Low - dose group: Specification: 12g/bag.
Control group:
(1) Extremely low - dose group: Specification: 12g/bag.
Rescue medication:
(1) Paracetamol ta
Sign in to get the eligibility rules as simple questions to take to your doctor.
📋 Eligibility rules (as published)
Inclusion Criteria:
1. Meeting the Western medicine diagnostic criteria for acute pharyngitis.
2. Meeting the TCM syndrome differentiation criteria for the syndrome of wind-heat invading the exterior.
3. The disease course at the time of visit is ≤ 48 hours.
4. The VAS score for pharyngeal pain is ≥ 4 points, and the pharyngeal sign score is ≥ 1 point.
5. Age between 18 and 65 years old (including the boundary values), regardless of gender.
6. Voluntarily participating in this clinical trial and signing the informed consent form.
Exclusion Criteria:
1. Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.
2. Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia.
3. Those with a modified Centor score ≥ 2 points, a peak body temperature \> 38.5°C (axillary temperature) within 24 hours before this visit, a white blood cell count \> 1.2 × ULN, a neutrophil percentage \> 1.2 × ULN, and suspected bacterial infection considered by the researcher.
4. Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases.
5. Those with a history of thyroid-related diseases such as hyperthyroidism or hypothyroidism.
6. Those with laboratory test results indicating ALT \> 1.2 × ULN, AST \> 1.2 × ULN, or Cr \> 1 × ULN. Any one of these conditions will lead to exclusion.
7. Those who have used any other drugs for the treatment of acute pharyngitis, including drugs for relieving pharyngeal pain (such as traditional Chinese medicines, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.) within 48 hours before this visit.
8. Those who are allergic to the ingredients or excipients of the test drug.
9. Pregnant or lactating women.
10. Those suspected of or with a confirmed history of alcohol or drug abuse.
11. Patients who have participated in or are currently participating in other clinical trials within the past month.
12. Patients considered by the researcher to be unsuitable for participating in this clinical trial.
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