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
This trial does not accept healthy volunteersQualifiers
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
Design model
Parallel
Treatments tested in this trial
Yanlishuang Buccal Dropping Pills
DrugMiao 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 Placebo
DrugMatching 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.
Treatment groups
400 Participants
are divided into 2 treatment groupsGroup A: Yanlishuang Buccal Dropping PillsExperimental treatment 1 intervention
Group B: Matching PlaceboPlacebo comparator 1 intervention
Trial outcomes
Primary outcomes
1
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
1
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.2
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.3
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 6.4
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.Sponsors and contacts
Click on the lead sponsor to view all of their trials.
Source ClinicalTrials.gov
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