Yanlishuang Buccal Dropping Pills for Acute Pharyngitis

NCT07761013 | Not Yet Recruiting

• 1 other identifier: YNZYYLS-2026-06
• Study Type: interventional
• Target: 400
• Locations: 1 country
• Sites: 10

Brief 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

Keywords

acute pharyngitis; sore throat; swallowing pain; resting throat pain; visual analog scale; Miao medicine; Traditional Chinese Medicine; Yanlishuang; buccal dropping pills; placebo-controlled trial

Outcome Measures

Primary Outcomes (1)

• Time to complete sore throat resolution

  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.

  From the first dose until complete sore throat resolution, assessed up to Day 6.

Secondary Outcomes (41)

• Immediate analgesic effect on resting throat pain

  Days 1, 2, and 3: immediately pre-dose and 5, 30, and 60 minutes after the first daily dose.

• Immediate analgesic effect on swallowing pain

  Days 1, 2, and 3: immediately pre-dose and 5, 30, and 60 minutes after the first daily dose.

• Time to onset of relief of resting throat pain

  From the first dose until onset of relief of resting throat pain, assessed up to Day 6.

• Time to onset of relief of swallowing pain

  From the first dose until onset of relief of swallowing pain, assessed up to Day 6.

• Time to resolution of resting throat pain

  From the first dose until resolution of resting throat pain, assessed up to Day 6.

Study Arms (2)

Yanlishuang Buccal Dropping Pills

EXPERIMENTAL

Participants allow 4 Yanlishuang Buccal Dropping Pills to dissolve in the mouth per dose, 4 to 6 times daily, with at least 2 hours between doses, for up to 5 days. Each pill weighs 0.025 g.

Drug: Yanlishuang Buccal Dropping Pills

Matching Placebo

PLACEBO COMPARATOR

Participants allow 4 matching placebo buccal dropping pills to dissolve in the mouth per dose, 4 to 6 times daily, with at least 2 hours between doses, for up to 5 days. Each placebo pill weighs 0.025 g.

Drug: Yanlishuang Buccal Dropping Pills Placebo

Interventions

Yanlishuang Buccal Dropping Pills DRUG

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

Yanlishuang Buccal Dropping Pills Placebo DRUG

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.

Matching Placebo

Eligibility Criteria

• Age: 18 Years - 65 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Beijing University of Chinese Medicine: lead

Study Sites (10)

First Affiliated Hospital of Guangzhou University of Chinese Medicine

Guangzhou, Guangdong, China

Location

Affiliated Hospital of Guizhou Medical University

Guiyang, Guizhou, China

Location

First Affiliated Hospital of Heilongjiang University of Chinese Medicine

Harbin, Heilongjiang, China

Location

Jiangsu Province Hospital of Chinese Medicine

Nanjing, Jiangsu, China

Location

Jiangxi Provincial Hospital of Traditional Chinese Medicine

Nanchang, Jiangxi, China

Location

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

Jinan, Shandong, China

Location

Shanghai Municipal Hospital of Traditional Chinese Medicine

Shanghai, Shanghai Municipality, China

Location

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

Chengdu, Sichuan, China

Location

First Teaching Hospital of Tianjin University of Traditional Chinese Medicine

Tianjin, Tianjin Municipality, China

Location

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

Kunming, Yunnan, China

Location

MeSH Terms

Conditions

Pharyngitis

Condition Hierarchy (Ancestors)

Respiratory Tract Infections; Infections; Pharyngeal Diseases; Stomatognathic Diseases; Respiratory Tract Diseases; Otorhinolaryngologic Diseases

Study Officials

• Chunjiang Huang

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

  PRINCIPAL INVESTIGATOR

• Jianping Liu

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

  PRINCIPAL INVESTIGATOR

• Jianchang He

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

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: DOUBLE
• Who Masked: PARTICIPANT, INVESTIGATOR
• Masking Details: Participants and investigators will remain unaware of treatment assignment. Yanlishuang Buccal Dropping Pills and matching placebo will use identical packaging without markings that reveal group assignment. Final unblinding will occur after data review, statistical analysis plan finalization, and database lock; emergency unblinding is permitted when knowledge of treatment is required for participant safety.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Beijing University of Chinese Medicine

Model Details: Participants are randomized in a 1:1 ratio to Yanlishuang Buccal Dropping Pills or matching placebo for up to 5 days.

Study Record Dates

• First Submitted: August 4, 2026
• First Posted: August 12, 2026
• Study Start: August 1, 2026
• Primary Completion (Estimated): March 26, 2027
• Study Completion (Estimated): June 29, 2027
• Last Updated: August 12, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

CN (10)