An interventional study of Yanlishuang Buccal Dropping Pills and Yanlishuang Buccal Dropping Pills Placebo in Acute Pharyngitis, sponsored by Beijing University of Chinese Medicine. Not yet recruiting at 10 sites in China. Open to participants aged 18 Years to 65 Years. Per ClinicalTrials.gov, last updated 2026-08-12.
Sponsored by Beijing University of Chinese Medicine · Not applicable, Interventional, and Treatment
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.
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.
226 studies on the registry are indexed under Pharyngitis; 35 are open to participants now.
This study's planned enrollment of 400 is above the median of 144 across 188 interventional studies indexed under Pharyngitis.
Browse Pharyngitis studies →Beijing University of Chinese Medicine is the lead sponsor of 32 studies on the registry; 8 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Absolute neutrophil count (ANC)
The number of neutrophils, white blood cells that help fight infection, in a given amount of blood. Too few raises the risk of infection.
It is a count, not a percentage of the white cells. Limits are written in units that mean the same: ≥ 1.5 × 10⁹/L is ≥ 1,500 per mm³ (µL). Each lab has its own reference range.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ULN (upper limit of normal)
The top of the normal range for a blood test, as set by the laboratory that runs it. Each lab prints its own range next to your result.
“≤ 2.5 × ULN” means the result can be up to two and a half times that top value.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Investigational drug or device
A drug or device being studied in a clinical trial.
It may be new, or already approved and being studied for another use, dose or form. Criteria often leave out people who took part in another study of one within a recent period, commonly 30 days or five half-lives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
Drug: Yanlishuang Buccal Dropping Pills
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.
Drug: Yanlishuang Buccal Dropping Pills Placebo
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.
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.
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.
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.
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.
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.
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.
Time to resolution of resting throat pain
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 frame: From the first dose until resolution of resting throat pain, assessed up to Day 6.
Time to resolution of swallowing pain
Time from the first dose until the swallowing-pain visual analog scale score is 0 and remains 0 for at least 24 hours.
Time frame: From the first dose until resolution of swallowing pain, assessed up to Day 6.
Complete sore throat resolution rate
Proportion of participants whose swallowing-pain and resting-throat-pain visual analog scale scores are both 0 at the specified assessment.
Time frame: 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
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.
Time frame: 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
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.
Time frame: Baseline, Day 3, and Day 5; the Day 5 assessment may be conducted on Day 6.
Traditional Chinese Medicine syndrome response rate
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.
Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.
Resolution rate of individual Traditional Chinese Medicine syndrome symptoms
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.
Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.
Throat physical-sign resolution rate
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.
Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.
Incidence of acute pharyngitis complications
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.
Time frame: From the first dose through Day 6.
Work absence due to acute pharyngitis
Number and proportion of employed/commuting participants who miss work because of acute pharyngitis during the treatment period.
Time frame: From the first dose through Day 6.
Duration of work absence due to acute pharyngitis
Total duration of work absence attributable to acute pharyngitis among employed/commuting participants.
Time frame: From the first dose through Day 6.
Change from baseline in axillary body temperature
Change in axillary body temperature as a vital-sign safety assessment.
Time frame: Baseline and final visit on Day 6 (Day 5 + 1-day window).
Change from baseline in pulse rate
Change in pulse rate as a vital-sign safety assessment.
Time frame: Baseline and final visit on Day 6.
Change from baseline in respiratory rate
Change in respiratory rate as a vital-sign safety assessment.
Time frame: Baseline and final visit on Day 6.
Change from baseline in systolic blood pressure
Change in systolic blood pressure as a vital-sign safety assessment.
Time frame: Baseline and final visit on Day 6.
Change from baseline in diastolic blood pressure
Change in diastolic blood pressure as a vital-sign safety assessment.
Time frame: Baseline and final visit on Day 6.
Change from baseline in red blood cell count
Change in red blood cell count as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in hemoglobin level
Change in hemoglobin level as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in platelet count
Change in platelet count as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in white blood cell count
Change in white blood cell count as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in absolute neutrophil count
Change in absolute neutrophil count as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in neutrophil percentage
Change in neutrophil percentage as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in absolute lymphocyte count
Change in absolute lymphocyte count as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in lymphocyte percentage
Change in lymphocyte percentage as a hematology safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in C-reactive protein level
Change in C-reactive protein level as a laboratory safety and inflammation measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in alanine aminotransferase level
Change in alanine aminotransferase level as a liver-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in aspartate aminotransferase level
Change in aspartate aminotransferase level as a liver-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in total bilirubin level
Change in total bilirubin level as a liver-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in alkaline phosphatase level
Change in alkaline phosphatase level as a liver-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in gamma-glutamyl transferase level
Change in gamma-glutamyl transferase level as a liver-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in blood urea nitrogen level
Change in blood urea nitrogen level as a renal-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Change from baseline in serum creatinine level
Change in serum creatinine level as a renal-function safety laboratory measure.
Time frame: Baseline and final visit on Day 6.
Clinically significant changes in physical examination findings
Number and proportion of participants with new or worsened clinically significant physical examination findings after treatment, based on the investigator assessment.
Time frame: Baseline and final visit on Day 6.
Clinically significant 12-lead electrocardiogram abnormalities
Number and proportion of participants with new or worsened clinically significant abnormalities on 12-lead electrocardiogram after treatment.
Time frame: Baseline and final visit on Day 6.
Incidence of adverse events
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.
Time frame: From the first dose through Day 6.
Incidence of serious adverse events
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.
Time frame: From the first dose through Day 6.
Incidence of suspected unexpected serious adverse reactions
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.
Time frame: From the first dose through Day 6.
Plan to share: No — Individual participant data will not be shared with other researchers. Study findings will be reported only in aggregate form.
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Mar 2027, 7 months later.
Of 58 non-industry interventional studies with no phase under Pharyngitis, half reached primary completion within 9 months of starting (the median), counting those still running; a quarter within 5 and three quarters within 17. This study's planned 7 months is below that.
Counting every sponsor, half of 63 studies reached it within 10 months; a quarter within 5 and three quarters within 17.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
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Beijing University of Chinese Medicine