Yanlishuang Buccal Dropping Pills for Acute Pharyngitis

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.

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.

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

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

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

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.

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.

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.

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.

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

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

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

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

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

Change in systolic blood pressure as a vital-sign safety assessment.

Change in diastolic blood pressure as a vital-sign safety assessment.

Change in red blood cell count as a hematology safety laboratory measure.

Change in hemoglobin level as a hematology safety laboratory measure.

Change in platelet count as a hematology safety laboratory measure.

Change in white blood cell count as a hematology safety laboratory measure.

Change in absolute neutrophil count as a hematology safety laboratory measure.

Change in neutrophil percentage as a hematology safety laboratory measure.

Change in absolute lymphocyte count as a hematology safety laboratory measure.

Change in lymphocyte percentage as a hematology safety laboratory measure.

Change in C-reactive protein level as a laboratory safety and inflammation measure.

Change in alanine aminotransferase level as a liver-function safety laboratory measure.

Change in aspartate aminotransferase level as a liver-function safety laboratory measure.

Change in total bilirubin level as a liver-function safety laboratory measure.

Change in alkaline phosphatase level as a liver-function safety laboratory measure.

Change in gamma-glutamyl transferase level as a liver-function safety laboratory measure.

Change in blood urea nitrogen level as a renal-function safety laboratory measure.

Change in serum creatinine level as a renal-function safety laboratory measure.

Number and proportion of participants with new or worsened clinically significant physical examination findings after treatment, based on the investigator assessment.

Number and proportion of participants with new or worsened clinically significant abnormalities on 12-lead electrocardiogram after treatment.

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.

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.

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.