Qinqiao Yan Shu Granules for treating acute pharyngitis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This clinical trial investigates the effects of Qinqiao Yan Shu Granules on patients with acute pharyngitis characterized by the wind-heat syndrome. It employs a block-randomized, double-blind, dose-escalation design across multiple centers, enrolling a total of 216 participants divided into high-dose, low-dose, and extremely low-dose groups. The trial aims to assess symptom improvement and safety of the granules compared to a control group receiving a very low dose. Participants will be monitored for changes in their condition and any adverse effects.

Why it matters

Who can join: the full rules

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.

Where it's running

• The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
  Harbin, Heilongjiang, China Recruiting
• The First Affiliated Hospital of Hunan University of Chinese Medicine
  Changsha, Hunan, China Recruiting
• Affiliated Hospital of Changchun University of Chinese Medicine
  Changchun, Jilin, China Recruiting
• Affiliated Hospital of Shandong University of Traditional Chinese Medicine
  Jinan, Shandong, China Recruiting
• The Affiliated Traditional Chinese Medicine Hospital of Southwest Medical University
  Luzhou, Sichuan, China Recruiting
• First Affiliated Hospital of Tianjin University of Traditional Chinese Medicine
  Tianjin, Tianjin Municipality, China Recruiting

Study contacts

• Study coordinator: Gang Zhao
• Email: 158200458@qq.com
• Phone: 86+02784514002

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.