Skip to content

A Randomized Controlled Trial Evaluating the Efficacy and Safety of Qingyan Drop Pills in Treating Acute Pharyngitis (Exogenous Wind-Heat Syndrome)

A Randomized, Open-Label, Positive-Controlled, Multicenter Clinical Trial Evaluating the Efficacy and Safety of Qingyan Drop Pills in Treating Acute Pharyngitis (Exogenous Wind-Heat Syndrome)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025001702
Enrollment
Unknown
Registered
2025-09-11
Start date
2024-09-06
Completion date
Unknown
Last updated
2025-10-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pharyngitis

Interventions

Experimental group:Qingyan Drop Pills: Administer sublingually, 6 pills per dose, 3 times dail
Control group:Lanqin Oral Solution: Take orally, 1 bottle per dose, 3 times daily.

Sponsors

Peking University First Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1.Meet the Western medical diagnostic criteria for acute pharyngitis; 2.Meet the TCM diagnostic criteria for external wind-heat syndrome; 3.Age between 18 and 65 years (inclusive); 4.Body temperature = 38.5°C; 5.Sore throat Visual Analog Scale (VAS) score = 4 points; 6.Onset within 48 hours; 7.Voluntarily signed informed consent form.

Exclusion criteria

Exclusion criteria: 1.Complicated with bacterial otitis media, sinusitis, laryngitis, bronchitis, pneumonia, acute nephritis, rheumatic fever, septicemia, or other similar conditions. 2.Presence of suppurative tonsillitis, peritonsillar abscess, or retropharyngeal abscess; or pharyngeal symptoms/inflammation caused by measles, scarlet fever, influenza, agranulocytosis, infectious mononucleosis, leukemia, or other diseases. 3.Complete blood count showing leukocyte count = 12 × 10^9/L or neutrophil percentage (NEUT) = 1.2 times the upper limit of the normal reference range. 4.Use of any Western or traditional Chinese medicine for this condition within the past 24 hours, or concurrent need for antibiotics/antiviral therapy due to other diseases. 5.Severe cardiovascular diseases (e.g., unstable angina within the past 3 months; heart failure history or NYHA Class = III within the past 6 months; myocardial infarction, shock, or life-threatening arrhythmia within the past 6 months; coronary artery bypass grafting or percutaneous coronary intervention within the past 6 months), severe pulmonary diseases, severe hematologic disorders (e.g., thalassemia, sickle cell anemia, myelodysplastic syndromes, hemolytic anemia), or other significant bleeding disorders. 6.Neurological or psychiatric disorders impairing cooperation or unwillingness to cooperate; history of alcohol/drug abuse. 7.Allergic constitution or history of allergies to two or more drugs (or to known components of the study drug). 8.Pregnant women, women planning pregnancy, or lactating women. 9.Participation in another clinical trial within the past 3 months. 10.Other conditions deemed unsuitable for trial participation by the investigator.

Design outcomes

Primary

MeasureTime frame
Onset time for immediate relief of sore throat pain (including pain on swallowing);

Secondary

MeasureTime frame
Duration of immediate analgesic effect for sore throat pain (including pain on swallowing);Efficacy rate of immediate analgesia for sore throat pain (including pain on swallowing);Time to resolution of sore throat pain (including pain on swallowing);Change in Visual Analog Scale (VAS) score for sore throat pain (including pain on swallowing) at the end of treatment;Efficacy on Traditional Chinese Medicine (TCM) Syndrome Patterns;

Countries

China

Contacts

Public ContactWang Yuanzheng

Peking University First Hospital

wangyuanzheng1981@sina.com13810669064

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026