Qinqiao Yan Shu Granules for the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome) Phase II Clinical Trial

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 tablets: Specification: 0.5g/tablet. Dosage and Administration： High - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Extremely low - dose group: Dissolve in boiling water and take 1 bag each time, 3 times a day, half an hour before meals; Rescue medication: Paracetamol tablets. During the trial, if the subject's body temperature exceeds 38.5°C (including 38.5°C), rescue medication can be added. Use it according to the instructions and doctor's advice and record it truthfully.

Treatment Course：5 days Efficacy Indicators：

1. The disappearance rate of pharyngeal pain 3 days and 5 days after treatment; 2) The change value of the pharyngeal pain VAS score compared with the baseline 5 days after treatment; 3) The time to disappearance of pharyngeal pain; 4) The effective rate of pharyngeal signs 5 days after treatment; 5) The clinical cure rate of the disease 5 days after treatment; 6) The efficacy of TCM syndromes 5 days after treatment; 7) The disappearance rate of single symptoms 5 days after treatment; 8) The frequency of rescue drug use. Measurement and Definition of Endpoint Indicators：
2. The criterion for the disappearance of pharyngeal pain: The pharyngeal pain VAS score drops to 0 points and persists for 24 hours or more.
3. Pharyngeal pain VAS score: Starting from the evaluation time of the VAS score during the screening period, the subject evaluates once every 24 hours (±1 hour) and records the most severe degree of pharyngeal pain in the past 24 hours in the diary card.
4. The criterion for the effective rate of pharyngeal signs: "Effective" is defined as a decrease of at least 1 point in the pharyngeal sign score. The effective rate = (Number of effective cases / Total number of cases) × 100%.
5. The criterion for the clinical cure of the disease: The clinical symptoms of the disease disappear, and the pharyngeal signs are reduced to mild or less. The cure rate = (Number of cured cases / Total number of cases) × 100%.
6. The definition of the efficacy of TCM syndromes:

Efficacy of TCM syndromes: Cure means that the TCM syndrome score decreases by ≥ 95%; Marked effect means that the TCM syndrome score decreases by ≥ 70% and < 95%; Effective means that the TCM syndrome score decreases by ≥ 30% and < 70%; Ineffective means that it does not meet the above criteria.

The change value of the pharyngeal pain VAS score compared with the baseline = The baseline pharyngeal pain VAS score - The pharyngeal pain VAS score on the 6th day.

Study Population；

Inclusion criteria:

1. Meeting the Western medical diagnostic criteria for acute pharyngitis;
2. Meeting the TCM syndrome differentiation criteria for Wind - Heat Exogenous Syndrome;
3. The course of the disease at the time of consultation ≤ 48 hours;
4. The pharyngeal pain VAS score ≥ 4 points and the pharyngeal sign score ≥ 1 point;
5. Aged 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, a body temperature peak > 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 considered to be bacterial infections 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 and hypothyroidism;
6. Those with laboratory test results