Yanlishuang Buccal Dropping Pills for Acute Pharyngitis
Condition(s) studied
Investigational drug(s) / intervention(s)
Yanlishuang Buccal Dropping Pills: Miao medicine buccal dropping pills supplied by the sponsor. The protocol lists Aipian/natural borneol, Blumea balsamifera oil, peppermint oil, menthol, and monoammonium glycyrrhizinate, with polyethylene glycol 6000 as excipient. Dose: 4 pills buccally per administration, 4 to 6 administrations per day, at intervals of at least 2 hours, for up to 5 days.
Yanlishuang Buccal Dropping Pills Placebo: Matching placebo with identical dosage form, weight, packaging, schedule, and administration: 4 pills buccally per administration, 4 to 6 administrations per day, at intervals of at least 2 hours, for up to 5 days.
Study summary
Acute pharyngitis commonly causes sore throat and pain on swallowing. This multicenter trial will compare Yanlishuang Buccal Dropping Pills with a matching placebo in 400 adults aged 18 to 65 years whose acute pharyngitis began within 48 hours and whose baseline throat-pain visual analog scale score is at least 4. Participants will be randomized 1:1 and treated under double-blind conditions. Each group will use four buccal dropping pills 4 to 6 times daily at intervals of at least 2 hours for up to 5 days. Participants whose sore throat resolves after at least 72 hours and remains absent for at least 24 hours may stop treatment early. The primary outcome is time to complete sore throat resolution. Secondary outcomes assess immediate pain relief, onset and resolution of pain, symptom and physical-sign response, complications, and work absence. Safety will be assessed using physical examinations, vital signs, laboratory tests, electrocardiograms, and adverse events.
Eligibility
Primary outcome measure(s)
- Time to complete sore throat resolution — From the first dose until complete sore throat resolution, assessed up to Day 6.
Time in hours from the first dose to the first assessment at which both swallowing-pain and resting-throat-pain visual analog scale scores are 0 and remain 0 for at least 24 hours. Participants record the worst pain experienced during the preceding 24 hours.
Trial sites (10)
| Facility | City | Region | Status |
|---|---|---|---|
| First Affiliated Hospital of Guangzhou University of Chinese Medicine | Guangzhou | Guangdong | |
| Affiliated Hospital of Guizhou Medical University | Guiyang | Guizhou | |
| First Affiliated Hospital of Heilongjiang University of Chinese Medicine | Harbin | Heilongjiang | |
| Jiangsu Province Hospital of Chinese Medicine | Nanjing | Jiangsu | |
| Jiangxi Provincial Hospital of Traditional Chinese Medicine | Nanchang | Jiangxi | |
| First Affiliated Hospital of Shandong University of Traditional Chinese Medicine / Shandong Provincial Hospital of Traditional Chinese Medicine | Jinan | Shandong | |
| Shanghai Municipal Hospital of Traditional Chinese Medicine | Shanghai | Shanghai Municipality | |
| Affiliated Hospital of Chengdu University of Traditional Chinese Medicine / Sichuan Provincial Hospital of Traditional Chinese Medicine | Chengdu | Sichuan | |
| First Teaching Hospital of Tianjin University of Traditional Chinese Medicine | Tianjin | Tianjin Municipality | |
| First Affiliated Hospital of Yunnan University of Chinese Medicine / Yunnan Provincial Hospital of Traditional Chinese Medicine | Kunming | Yunnan |
More Beijing University of Chinese Medicine trials in China
Other trials for the same condition
This page summarises publicly available registry data for informational purposes — not medical advice. Eligibility is determined by each study team; patients should discuss participation with their clinician.
View NCT07761013 on ClinicalTrials.gov ↗ ← All trials in China