Acute Pharyngitis
Conditions
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
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.
Detailed description
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.
Interventions
DRUGYanlishuang 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.
DRUGYanlishuang 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
Beijing University of Chinese Medicine
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
DOUBLE (Subject, Investigator)
Masking description
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.
Intervention model description
Participants are randomized in a 1:1 ratio to Yanlishuang Buccal Dropping Pills or matching placebo for up to 5 days.
Eligibility
Sex/Gender
ALL
Age
18 Years to 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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| 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. | 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. |
| 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. | 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 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 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 to onset of relief of swallowing pain | From the first dose until onset of relief of swallowing pain, assessed up to Day 6. | 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 to resolution of resting throat pain | From the first dose until resolution of resting throat pain, assessed up to Day 6. | 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 to resolution of swallowing pain | From the first dose until resolution of swallowing pain, assessed up to Day 6. | Time from the first dose until the swallowing-pain visual analog scale score is 0 and remains 0 for at least 24 hours. |
| 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. | Proportion of participants whose swallowing-pain and resting-throat-pain visual analog scale scores are both 0 at the specified assessment. |
| 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 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. |
| 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. | 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. |
| Traditional Chinese Medicine syndrome response rate | Baseline and Day 5; the Day 5 assessment may be conducted on Day 6. | 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. |
| Resolution rate of individual Traditional Chinese Medicine syndrome symptoms | Baseline and Day 5; the Day 5 assessment may be conducted on Day 6. | 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. |
| Throat physical-sign resolution rate | Baseline and Day 5; the Day 5 assessment may be conducted on Day 6. | 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. |
| Incidence of acute pharyngitis complications | From the first dose through Day 6. | 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. |
| Work absence due to acute pharyngitis | From the first dose through Day 6. | Number and proportion of employed/commuting participants who miss work because of acute pharyngitis during the treatment period. |
| Duration of work absence due to acute pharyngitis | From the first dose through Day 6. | Total duration of work absence attributable to acute pharyngitis among employed/commuting participants. |
| Change from baseline in axillary body temperature | Baseline and final visit on Day 6 (Day 5 + 1-day window). | Change in axillary body temperature as a vital-sign safety assessment. |
| Change from baseline in pulse rate | Baseline and final visit on Day 6. | Change in pulse rate as a vital-sign safety assessment. |
| Change from baseline in respiratory rate | Baseline and final visit on Day 6. | Change in respiratory rate as a vital-sign safety assessment. |
| Change from baseline in systolic blood pressure | Baseline and final visit on Day 6. | Change in systolic blood pressure as a vital-sign safety assessment. |
| Change from baseline in diastolic blood pressure | Baseline and final visit on Day 6. | Change in diastolic blood pressure as a vital-sign safety assessment. |
| Change from baseline in red blood cell count | Baseline and final visit on Day 6. | Change in red blood cell count as a hematology safety laboratory measure. |
| Change from baseline in hemoglobin level | Baseline and final visit on Day 6. | Change in hemoglobin level as a hematology safety laboratory measure. |
| Change from baseline in platelet count | Baseline and final visit on Day 6. | Change in platelet count as a hematology safety laboratory measure. |
| Change from baseline in white blood cell count | Baseline and final visit on Day 6. | Change in white blood cell count as a hematology safety laboratory measure. |
| Change from baseline in absolute neutrophil count | Baseline and final visit on Day 6. | Change in absolute neutrophil count as a hematology safety laboratory measure. |
| Change from baseline in neutrophil percentage | Baseline and final visit on Day 6. | Change in neutrophil percentage as a hematology safety laboratory measure. |
| Change from baseline in absolute lymphocyte count | Baseline and final visit on Day 6. | Change in absolute lymphocyte count as a hematology safety laboratory measure. |
| Change from baseline in lymphocyte percentage | Baseline and final visit on Day 6. | Change in lymphocyte percentage as a hematology safety laboratory measure. |
| Change from baseline in C-reactive protein level | Baseline and final visit on Day 6. | Change in C-reactive protein level as a laboratory safety and inflammation measure. |
| Change from baseline in alanine aminotransferase level | Baseline and final visit on Day 6. | Change in alanine aminotransferase level as a liver-function safety laboratory measure. |
| Change from baseline in aspartate aminotransferase level | Baseline and final visit on Day 6. | Change in aspartate aminotransferase level as a liver-function safety laboratory measure. |
| Change from baseline in total bilirubin level | Baseline and final visit on Day 6. | Change in total bilirubin level as a liver-function safety laboratory measure. |
| Change from baseline in alkaline phosphatase level | Baseline and final visit on Day 6. | Change in alkaline phosphatase level as a liver-function safety laboratory measure. |
| Change from baseline in gamma-glutamyl transferase level | Baseline and final visit on Day 6. | Change in gamma-glutamyl transferase level as a liver-function safety laboratory measure. |
| Change from baseline in blood urea nitrogen level | Baseline and final visit on Day 6. | Change in blood urea nitrogen level as a renal-function safety laboratory measure. |
| Change from baseline in serum creatinine level | Baseline and final visit on Day 6. | Change in serum creatinine level as a renal-function safety laboratory measure. |
| Clinically significant changes in physical examination findings | Baseline and final visit on Day 6. | Number and proportion of participants with new or worsened clinically significant physical examination findings after treatment, based on the investigator assessment. |
| Clinically significant 12-lead electrocardiogram abnormalities | Baseline and final visit on Day 6. | Number and proportion of participants with new or worsened clinically significant abnormalities on 12-lead electrocardiogram after treatment. |
| Incidence of adverse events | From the first dose through Day 6. | Number and proportion of participants with one or more adverse events after receiving study medication. Events will be coded using MedDRA and summarized by system organ class and preferred term. Unresolved adverse events will be followed until resolution, stabilization, a reasonable explanation, loss to follow-up, or investigator determination that further follow-up is unnecessary. |
| Incidence of serious adverse events | From the first dose through Day 6. | Number and proportion of participants with one or more serious adverse events after receiving study medication. Serious adverse events will be followed and reported according to the protocol. |
| Incidence of suspected unexpected serious adverse reactions | From the first dose through Day 6. | Number and proportion of participants with one or more suspected unexpected serious adverse reactions related to study medication. Events will be followed and reported according to the protocol. |
Countries
China
Contacts
PRINCIPAL_INVESTIGATORChunjiang Huang
Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
PRINCIPAL_INVESTIGATORJianping Liu
Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
PRINCIPAL_INVESTIGATORJianchang He
Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
Outcome results
None listed