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Starting soon Not applicable

Yanlishuang Buccal Dropping Pills for Acute Pharyngitis

NCT07761013 · tracked via the Priya Life Science China tracker
Phase
Not applicable
Started
2026-08-01
Last updated
2026-08-12

Condition(s) studied

Acute Pharyngitis

Investigational drug(s) / intervention(s)

Yanlishuang Buccal Dropping PillsYanlishuang Buccal Dropping Pills Placebo

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

Sex
ALL
Min age
18 Years
Max age
65 Years
Healthy volunteers
No
Inclusion Criteria: * Age 18 to 65 years, inclusive, of any sex. * Baseline throat-pain visual analog scale score of at least 4. * Meets the protocol-defined Western medicine diagnostic criteria for acute pharyngitis. * Acute onset with disease duration of 48 hours or less. * Provides written informed consent and is able to follow the study protocol. Exclusion Criteria: * Prior use of Yanlishuang Buccal Dropping Pills before enrollment, or use before enrollment of any other Chinese or Western medicine for the target disease that, in the investigator's judgment, may affect efficacy evaluation. * Prodromal or accompanying throat symptoms of an acute infectious disease, such as measles, scarlet fever, or infectious mononucleosis; suppurative tonsillitis; peritonsillar abscess; retropharyngeal abscess; acute epiglottitis; or throat symptoms caused by another disease. * Modified Centor score of at least 2, with white blood cell count, absolute neutrophil count, and C-reactive protein all above the upper limit of normal, when the investigator considers bacterial infection or antibiotic treatment necessary. * Concurrent bacterial otitis media, sinusitis, laryngitis, bronchitis, pneumonia, acute nephritis, rheumatic fever, sepsis, or a similar complication. * Severe primary disease of the central nervous, hematopoietic, endocrine, cardiovascular/cerebrovascular, digestive, or other system, or a psychiatric disorder, that the investigator considers may affect participant safety or materially affect clinical evaluation. * Abnormal hepatic or renal function: alanine aminotransferase or aspartate aminotransferase greater than 1.5 times the upper limit of normal and/or serum creatinine above the upper limit of normal. * Suspected or confirmed history of alcohol or drug abuse. * Pregnancy, breastfeeding, preparation for pregnancy, or a recent childbearing plan. * Known allergy to any component of the study medication. * Participation in another clinical trial and use of an investigational product within the previous 1 month. * Constitutional spleen-stomach deficiency-cold or a condition considered unsuitable for study medication, including but not limited to acute or chronic gastritis, erosive gastritis, or gastroesophageal reflux disease. * Any other condition that the investigator considers makes the individual unsuitable for participation.

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)

FacilityCityRegionStatus
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
Official registry record

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