Yanlishuang Buccal Dropping Pills for Acute Pharyngitis

N/ANot Yet RecruitingNCT07761013

Beijing University of Chinese Medicine400 enrolled

Overview

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.

This is a randomized, double-blind, placebo-controlled, parallel-group, multicenter clinical trial. A total of 400 eligible participants will be assigned in a 1:1 ratio to Yanlishuang Buccal Dropping Pills or matching placebo. Block randomization will be generated with SAS by a statistician not involved in the final study analysis. Study drug and placebo will have identical packaging and labeling to maintain masking. Participants will record resting throat pain and swallowing pain using a 0-to-10 visual analog scale in a daily log. The first dose is taken immediately after study medication is dispensed. Treatment continues for 5 days; participants with complete sore throat resolution after at least 72 hours, maintained for 24 hours or longer, may complete all final safety assessments and end participation early. Other local throat treatments, drugs with similar therapeutic effects, and efficacy-influencing nonpharmacologic treatments are prohibited. Acetaminophen may be used as rescue medication under protocol-specified fever or intolerable-discomfort conditions, and all concomitant medication will be recorded.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Interventions

Yanlishuang Buccal Dropping PillsDRUG

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 PlaceboDRUG

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.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 65 Years

Medical Language ↔ Plain English

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.

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

Outcomes

Primary Outcomes

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.

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

Secondary Outcomes

Immediate analgesic effect on resting throat pain

Change from the pre-dose resting-throat-pain visual analog scale score after the first daily dose. The visual analog scale ranges from 0 (no pain) to 10 (very severe pain); a larger reduction indicates greater immediate pain relief.

Time frame: 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

Change from the pre-dose swallowing-pain visual analog scale score after the first daily dose. The visual analog scale ranges from 0 (no pain) to 10 (very severe pain); a larger reduction indicates greater immediate pain relief.

Time frame: 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

Time from the first dose until the worst resting-throat-pain visual analog scale score during the preceding 24 hours is reduced by at least 50 percent from baseline.

Time frame: 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

Time from the first dose until the worst swallowing-pain visual analog scale score during the preceding 24 hours is reduced by at least 50 percent from baseline.

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

Time to resolution of resting throat pain

Time from the first dose until the resting-throat-pain visual analog scale score is 0 and remains 0 for at least 24 hours.

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

Time to resolution of swallowing pain

Time from the first dose until the swallowing-pain visual analog scale score is 0 and remains 0 for at least 24 hours.

Time frame: From the first dose until resolution of swallowing pain, assessed up to Day 6.

Complete sore throat resolution rate

Proportion of participants whose swallowing-pain and resting-throat-pain visual analog scale scores are both 0 at the specified assessment.

Time frame: Day 3 and Day 5; the final Day 5 assessment may be conducted within the Day 5 + 1-day visit window.

Change from baseline in resting throat pain visual analog scale score

Change from baseline in the resting-throat-pain visual analog scale score. The scale ranges from 0 (no pain) to 10 (very severe pain); a negative change indicates improvement.

Time frame: Baseline, Day 3, and Day 5; the Day 5 assessment may be conducted on Day 6.

Change from baseline in swallowing pain visual analog scale score

Change from baseline in the swallowing-pain visual analog scale score. The scale ranges from 0 (no pain) to 10 (very severe pain); a negative change indicates improvement.

Time frame: Baseline, Day 3, and Day 5; the Day 5 assessment may be conducted on Day 6.

Traditional Chinese Medicine syndrome response rate

Proportion of participants with at least a 50 percent decrease from baseline in the protocol-defined Traditional Chinese Medicine syndrome score. The score is the sum of primary-symptom and secondary-symptom item scores.

Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.

Resolution rate of individual Traditional Chinese Medicine syndrome symptoms

For each individual symptom item in the protocol-defined Traditional Chinese Medicine syndrome scale, resolution is defined as a post-treatment item score of 0. Each symptom item will be summarized separately.

Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.

Throat physical-sign resolution rate

Proportion of participants whose protocol-defined throat physical-sign score decreases to 0 after treatment. The assessment includes pharyngeal mucosal congestion, posterior pharyngeal-wall lymphoid follicle swelling, lateral pharyngeal-band swelling, uvula/soft-palate redness and swelling, and submandibular lymph-node enlargement.

Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.

Incidence of acute pharyngitis complications

Proportion of participants who develop protocol-specified complications during treatment, including bacterial otitis media, sinusitis, laryngitis, bronchitis, pneumonia, acute nephritis, rheumatic fever, sepsis, or other clinically diagnosed complications.

Time frame: From the first dose through Day 6.

Work absence due to acute pharyngitis

Number and proportion of employed/commuting participants who miss work because of acute pharyngitis during the treatment period.

Time frame: From the first dose through Day 6.

Duration of work absence due to acute pharyngitis

Total duration of work absence attributable to acute pharyngitis among employed/commuting participants.

Time frame: From the first dose through Day 6.

Change from baseline in axillary body temperature

Change in axillary body temperature as a vital-sign safety assessment.

Time frame: Baseline and final visit on Day 6 (Day 5 + 1-day window).

Change from baseline in pulse rate

Change in pulse rate as a vital-sign safety assessment.