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

Launched by JIANMIN PHARMACEUTICAL GROUP CO., LTD. · Apr 10, 2025

Keywords

ClinConnect Summary

This clinical trial is studying a treatment called Qinqiao Yan Shu Granules for people suffering from acute pharyngitis, which is a sore throat often caused by an infection. The main goal of the trial is to see how effective different doses of this treatment are in relieving symptoms and speeding up recovery. The researchers will also check if the granules are safe to use. The trial will involve 216 participants who will be divided into three groups to receive either high, low, or very low doses of the granules over five days.

To join the trial, participants must be between 18 and 65 years old, have been diagnosed with acute pharyngitis for less than 48 hours, and have a certain level of throat pain. They should not have other serious infections or health issues that could interfere with the study. Participants can expect to take the granules three times a day and will keep track of their symptoms. This trial aims to find a new way to help people feel better faster when they have a sore throat.

Gender

ALL

Eligibility criteria

• 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.