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
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 400
- 试验地点
- 10
- 主要终点
- Time to complete sore throat resolution
研究概览
简要总结
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.
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Double (Participant, Investigator)
盲法说明
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.
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Age 18 to 65 years, inclusive, of any sex.
- •Baseline throat-pain visual analog scale score of at least
- •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.
排除标准
- •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.
研究组 & 干预措施
Yanlishuang Buccal Dropping Pills
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.
干预措施: Yanlishuang Buccal Dropping Pills (Drug)
Matching Placebo
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.
干预措施: Yanlishuang Buccal Dropping Pills Placebo (Drug)
结局指标
主要结局
Time to complete sore throat resolution
时间窗: 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.
次要结局
- 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.)
- Time to resolution of swallowing pain(From the first dose until resolution of swallowing pain, assessed up to Day 6.)
- Complete sore throat resolution rate(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(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(Baseline, Day 3, and Day 5; the Day 5 assessment may be conducted on Day 6.)
- Traditional Chinese Medicine syndrome response rate(Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.)
- Resolution rate of individual Traditional Chinese Medicine syndrome symptoms(Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.)
- Throat physical-sign resolution rate(Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.)
- Incidence of acute pharyngitis complications(From the first dose through Day 6.)
- Work absence due to acute pharyngitis(From the first dose through Day 6.)
- Duration of work absence due to acute pharyngitis(From the first dose through Day 6.)
- Change from baseline in axillary body temperature(Baseline and final visit on Day 6 (Day 5 + 1-day window).)
- Change from baseline in pulse rate(Baseline and final visit on Day 6.)
- Change from baseline in respiratory rate(Baseline and final visit on Day 6.)
- Change from baseline in systolic blood pressure(Baseline and final visit on Day 6.)
- Change from baseline in diastolic blood pressure(Baseline and final visit on Day 6.)
- Change from baseline in red blood cell count(Baseline and final visit on Day 6.)
- Change from baseline in hemoglobin level(Baseline and final visit on Day 6.)
- Change from baseline in platelet count(Baseline and final visit on Day 6.)
- Change from baseline in white blood cell count(Baseline and final visit on Day 6.)
- Change from baseline in absolute neutrophil count(Baseline and final visit on Day 6.)
- Change from baseline in neutrophil percentage(Baseline and final visit on Day 6.)
- Change from baseline in absolute lymphocyte count(Baseline and final visit on Day 6.)
- Change from baseline in lymphocyte percentage(Baseline and final visit on Day 6.)
- Change from baseline in C-reactive protein level(Baseline and final visit on Day 6.)
- Change from baseline in alanine aminotransferase level(Baseline and final visit on Day 6.)
- Change from baseline in aspartate aminotransferase level(Baseline and final visit on Day 6.)
- Change from baseline in total bilirubin level(Baseline and final visit on Day 6.)
- Change from baseline in alkaline phosphatase level(Baseline and final visit on Day 6.)
- Change from baseline in gamma-glutamyl transferase level(Baseline and final visit on Day 6.)
- Change from baseline in blood urea nitrogen level(Baseline and final visit on Day 6.)
- Change from baseline in serum creatinine level(Baseline and final visit on Day 6.)
- Clinically significant changes in physical examination findings(Baseline and final visit on Day 6.)
- Clinically significant 12-lead electrocardiogram abnormalities(Baseline and final visit on Day 6.)
- Incidence of adverse events(From the first dose through Day 6.)
- Incidence of serious adverse events(From the first dose through Day 6.)
- Incidence of suspected unexpected serious adverse reactions(From the first dose through Day 6.)
研究者
Mei Han
Beijing University of Chinese Medicine
Beijing University of Chinese Medicine