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Yanlishuang Buccal Dropping Pills for Acute Pharyngitis

NCT07761013 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 400

Last updated 2026-08-12

No results posted yet for this 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.

Conditions

  • Acute Pharyngitis

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.

Sponsors & Collaborators

  • Beijing University of Chinese Medicine

    lead OTHER

Principal Investigators

  • Chunjiang Huang · Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine

  • Jianping Liu · Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine

  • Jianchang He · Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
DOUBLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Max Age
65 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-01
Primary Completion
2027-03-26
Completion
2027-06-29

Countries

  • China

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07761013 on ClinicalTrials.gov