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NCT07761013
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Yanlishuang Buccal Dropping Pills for Acute Pharyngitis

Sponsor: Beijing University of Chinese Medicine

View on ClinicalTrials.gov

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.

Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Miao Medicine Yanlishuang Buccal Dropping Pills in Adults With Acute Pharyngitis

Key Details

Gender

All

Age Range

18 Years - 65 Years

Study Type

INTERVENTIONAL

Enrollment

400

Start Date

2026-08-01

Completion Date

2027-06-29

Last Updated

2026-08-12

Healthy Volunteers

No

Interventions

DRUG

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.

DRUG

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.

Locations (10)

First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Jiangxi Provincial Hospital of Traditional Chinese Medicine

Nanchang, Jiangxi, China

First Affiliated Hospital of Shandong University of Traditional Chinese Medicine / Shandong Provincial Hospital of Traditional Chinese Medicine

Jinan, Shandong, China

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Affiliated Hospital of Chengdu University of Traditional Chinese Medicine / Sichuan Provincial Hospital of Traditional Chinese Medicine

Chengdu, Sichuan, China

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

First Affiliated Hospital of Yunnan University of Chinese Medicine / Yunnan Provincial Hospital of Traditional Chinese Medicine

Kunming, Yunnan, China