Qinqiao Yan Shu Granules for treating acute pharyngitis

A Randomized, Double-Blind, Dose-Exploration, Multicenter Phase II Clinical Trial to Evaluate the Efficacy and Safety of Qin Qiao Yan Shu Granules in the Treatment of Acute Pharyngitis (Exterior Wind-Heat Syndrome)

This study is testing if Qinqiao Yan Shu Granules can help people with acute pharyngitis feel better compared to a very low dose of the treatment.

Quick facts

• Phase: Phase 2
• Study type: Interventional
• Enrollment: 216 (estimated)
• Ages: 18 Years to 65 Years
• Sex: All
• Sponsor: Jianmin Pharmaceutical Group Co., LTD. (Industry-sponsored)
• Locations: 7 sites (Harbin, Heilongjiang and 6 other locations)
• Trial ID: NCT06932328 on ClinicalTrials.gov

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.

Who should consider this trial

Good fit: Ideal candidates are adults aged 18 to 65 who have been diagnosed with acute pharyngitis and exhibit specific symptoms related to the wind-heat syndrome.

Not a fit: Patients with pharyngeal symptoms due to other infections or conditions, such as measles or influenza, will not benefit from this study.

Why it matters

Potential benefit: If successful, this treatment could provide a new effective option for managing acute pharyngitis symptoms.

How similar studies have performed: While this approach is novel in the context of Qinqiao Yan Shu Granules, similar studies on herbal treatments for acute pharyngitis have shown promising results.

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.

Where this trial is running

Harbin, Heilongjiang and 6 other locations

• 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)
• Wenzhou Hospital of Traditional Chinese Medicine — Wenzhou, Zhejiang, China (Recruiting)

Study contacts

• Study coordinator: Gang Zhao

Conditions Acute Pharyngitis