Status:
RECRUITING
Qinqiao Yan Shu Granules for the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome) Phase II Clinical Trial
Lead Sponsor:
Jianmin Pharmaceutical Group Co., LTD.
Conditions:
Acute Pharyngitis
Eligibility:
All Genders
18-65 years
Phase:
PHASE2
Brief Summary
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...
Eligibility Criteria
Inclusion
- Meeting the Western medicine diagnostic criteria for acute pharyngitis.
- Meeting the TCM syndrome differentiation criteria for the syndrome of wind-heat invading the exterior.
- The disease course at the time of visit is ≤ 48 hours.
- The VAS score for pharyngeal pain is ≥ 4 points, and the pharyngeal sign score is ≥ 1 point.
- Age between 18 and 65 years old (including the boundary values), regardless of gender.
- Voluntarily participating in this clinical trial and signing the informed consent form.
Exclusion
- Those with pharyngeal symptoms or inflammation caused by measles, scarlet fever, agranulocytosis, infectious mononucleosis, influenza, diphtheria, acute epiglottitis, acute carotid arteritis, etc.
- Those with concurrent acute sinusitis, acute laryngitis, suppurative tonsillitis, bronchitis, pneumonia.
- 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.
- Those with concurrent severe primary diseases of the cardiovascular and cerebrovascular system, liver, kidney, hematopoietic system, endocrine system, and mental diseases.
- Those with a history of thyroid-related diseases such as hyperthyroidism or hypothyroidism.
- 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.
- 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.
- Those who are allergic to the ingredients or excipients of the test drug.
- Pregnant or lactating women.
- Those suspected of or with a confirmed history of alcohol or drug abuse.
- Patients who have participated in or are currently participating in other clinical trials within the past month.
- Patients considered by the researcher to be unsuitable for participating in this clinical trial.
Key Trial Info
Start Date :
March 26 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
December 31 2025
Estimated Enrollment :
216 Patients enrolled
Trial Details
Trial ID
NCT06932328
Start Date
March 26 2025
End Date
December 31 2025
Last Update
April 17 2025
Active Locations (7)
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1
The First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang, China, 150000
2
The First Affiliated Hospital of Hunan University of Chinese Medicine
Changsha, Hunan, China, 410000
3
Affiliated Hospital of Changchun University of Chinese Medicine
Changchun, Jilin, China, 130000
4
Affiliated Hospital of Shandong University of Traditional Chinese Medicine
Jinan, Shandong, China, 250000