Yanlishuang Buccal Dropping Pills for Acute Pharyngitis
ConditionAcute Pharyngitis
Trial statusNot yet recruiting
Trial phaseNot applicable
Trial typeInterventional
Biological sexAll
Age18-65
SponsorBeijing University of Chinese Medicine
About this trial
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.
Eligibility criteria
Qualifiers
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.
Disqualifiers
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.
Trial design
Treatments tested in this trial
- Yanlishuang Buccal Dropping Pills
- Yanlishuang Buccal Dropping Pills Placebo
Treatment groups
400 Participants
are divided into 2 treatment groupsSponsors and collaborators
Source ClinicalTrials.gov