Acute PharyngitisYLS-AP-RCTNCT07761013
Yanlishuang Buccal Dropping Pills for Acute Pharyngitis
A study testing Yanlishuang Buccal Dropping Pills in people with Acute Pharyngitis, run by Beijing University of Chinese Medicine at 10 sites in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 65 years
- Conditions the study is for
- Acute Pharyngitis
- What is being tested?
- Yanlishuang Buccal Dropping Pills
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 400 participants
- Where
- 10 sitesChina
- Study dates
- 1 Aug 2026to 29 Jun 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 65 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Show all 12Show fewer
- 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.
Trial locations and contacts
10 sites in 1 country. Contact the study team or a site near you to ask about taking part.
10 sites in 1 country
China10 sites
Affiliated Hospital of Chengdu University of Traditional Chinese Medicine / Sichuan Provincial Hospital of Traditional Chinese Medicine
Chengdu, Sichuan
First Affiliated Hospital of Guangzhou University of Chinese Medicine
Guangzhou, Guangdong
Affiliated Hospital of Guizhou Medical University
Guiyang, Guizhou
First Affiliated Hospital of Heilongjiang University of Chinese Medicine
Harbin, Heilongjiang
First Affiliated Hospital of Shandong University of Traditional Chinese Medicine / Shandong Provincial Hospital of Traditional Chinese Medicine
Jinan, Shandong
First Affiliated Hospital of Yunnan University of Chinese Medicine / Yunnan Provincial Hospital of Traditional Chinese Medicine
Kunming, Yunnan
Jiangxi Provincial Hospital of Traditional Chinese Medicine
Nanchang, Jiangxi
Jiangsu Province Hospital of Chinese Medicine
Nanjing, Jiangsu
Shanghai Municipal Hospital of Traditional Chinese Medicine
Shanghai, Shanghai Municipality
First Teaching Hospital of Tianjin University of Traditional Chinese Medicine
Tianjin, Tianjin Municipality
About this study
Official title: A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Miao Medicine Yanlishuang Buccal Dropping Pills in Adults With Acute Pharyngitis
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.
Read the 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.
- Conditions
- Acute Pharyngitis
- Being tested
- Yanlishuang Buccal Dropping Pills, Yanlishuang Buccal Dropping Pills Placebo
- 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
- Medical subject headings
- Pharyngitis
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Yanlishuang Buccal Dropping PillsDrug
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.
Yanlishuang Buccal Dropping Pills PlaceboDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| Yanlishuang Buccal Dropping Pills | Experimental | 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. Receives: Drug: Yanlishuang Buccal Dropping Pills |
| Matching Placebo | Placebo comparator | 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. Receives: Drug: Yanlishuang Buccal Dropping Pills Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From the first dose until complete sore throat resolution, assessed up to Day 6.
Secondary outcomes (41)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and final visit on Day 6.
Change from baseline in respiratory rate
Change in respiratory rate as a vital-sign safety assessment.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline and final visit on Day 6.
Change from baseline in hemoglobin level
Change in hemoglobin level as a hematology safety laboratory measure.
Measured: Baseline and final visit on Day 6.
Change from baseline in platelet count
Change in platelet count as a hematology safety laboratory measure.
Measured: 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.
Measured: 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.
Measured: Baseline and final visit on Day 6.
Change from baseline in neutrophil percentage
Change in neutrophil percentage as a hematology safety laboratory measure.
Measured: 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.
Measured: Baseline and final visit on Day 6.
Change from baseline in lymphocyte percentage
Change in lymphocyte percentage as a hematology safety laboratory measure.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: From the first dose through Day 6.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted12 Aug 2026
- Study start1 Aug 2026 (estimated)
- Primary completion26 Mar 2027 (estimated)
- Study completion29 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Acute PharyngitisStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants are randomized in a 1:1 ratio to Yanlishuang Buccal Dropping Pills or matching placebo for up to 5 days.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 400 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Beijing University of Chinese Medicine
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Mei Han, Beijing University of Chinese Medicine
- Investigators
- Chunjiang Huang, Principal investigator, Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese MedicineJianping Liu, Principal investigator, Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese MedicineJianchang He, Principal investigator, Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07761013
- Sponsor's protocol ID
- YNZYYLS-2026-06
- Acronym
- YLS-AP-RCT
- Status last verified
- Aug 2026
- First submitted
- 4 Aug 2026
- Last updated
- 12 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data will not be shared with other researchers. Study findings will be reported only in aggregate form.
Study at a glance
From the registry record, last updated by the sponsor on 12 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Multicenter, Randomized, Double-Blind, Placebo-Controlled, Parallel-Group Clinical Trial to Evaluate the Efficacy and Safety of Miao Medicine Yanlishuang Buccal Dropping Pills in Adults With Acute Pharyngitis
- ClinicalTrials.gov ID
- NCT07761013
- Acronym / sponsor ID
- YLS-AP-RCT / YNZYYLS-2026-06
- Conditions
- Acute Pharyngitis
- Keywords
- acute pharyngitis, sore throat, swallowing pain, resting throat pain, visual analog scale, Miao medicine, Traditional Chinese Medicine, Yanlishuang
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 400 participants (estimated)
- Lead sponsor
- Beijing University of Chinese MedicineUniversity, hospital or other
- Study start
- 1 Aug 2026 (estimated)
- Primary completion
- 26 Mar 2027 (estimated)
- Study completion
- 29 Jun 2027 (estimated)
- First posted
- 12 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- Participants are randomized in a 1:1 ratio to Yanlishuang Buccal Dropping Pills or matching placebo for up to 5 days.
| Arm | Type | Receives |
|---|---|---|
| Yanlishuang Buccal Dropping Pills | Experimental | Drug: Yanlishuang Buccal Dropping PillsParticipants 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. |
| Matching Placebo | Placebo comparator | Drug: Yanlishuang Buccal Dropping Pills PlaceboParticipants 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. |
Who may qualify
- Ages
- 18 to 65 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- 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.
Key exclusion criteria (12 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Yanlishuang Buccal Dropping PillsMiao 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. | Drug | Yanlishuang Buccal Dropping Pills |
| Yanlishuang Buccal Dropping Pills PlaceboMatching 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. | Drug | Matching Placebo |
Primary outcome
Time to complete sore throat resolution
Time frame: 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.
41 secondary outcomes
Immediate analgesic effect on resting throat pain
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
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 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 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 frame: From the first dose until resolution of resting throat pain, assessed up to Day 6.
Time to resolution of swallowing pain
Time frame: From the first dose until resolution of swallowing pain, assessed up to Day 6.
Complete sore throat resolution rate
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
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
Time frame: Baseline, Day 3, and Day 5; the Day 5 assessment may be conducted on Day 6.
Traditional Chinese Medicine syndrome response rate
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
Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.
Throat physical-sign resolution rate
Time frame: Baseline and Day 5; the Day 5 assessment may be conducted on Day 6.
Incidence of acute pharyngitis complications
Time frame: From the first dose through Day 6.
Work absence due to acute pharyngitis
Time frame: From the first dose through Day 6.
Duration of work absence due to acute pharyngitis
Time frame: From the first dose through Day 6.
Change from baseline in axillary body temperature
Time frame: Baseline and final visit on Day 6 (Day 5 + 1-day window).
Change from baseline in pulse rate
Time frame: Baseline and final visit on Day 6.
Change from baseline in respiratory rate
Time frame: Baseline and final visit on Day 6.
Change from baseline in systolic blood pressure
Time frame: Baseline and final visit on Day 6.
Change from baseline in diastolic blood pressure
Time frame: Baseline and final visit on Day 6.
Change from baseline in red blood cell count
Time frame: Baseline and final visit on Day 6.
Change from baseline in hemoglobin level
Time frame: Baseline and final visit on Day 6.
Change from baseline in platelet count
Time frame: Baseline and final visit on Day 6.
Change from baseline in white blood cell count
Time frame: Baseline and final visit on Day 6.
Change from baseline in absolute neutrophil count
Time frame: Baseline and final visit on Day 6.
Change from baseline in neutrophil percentage
Time frame: Baseline and final visit on Day 6.
Change from baseline in absolute lymphocyte count
Time frame: Baseline and final visit on Day 6.
Change from baseline in lymphocyte percentage
Time frame: Baseline and final visit on Day 6.
Change from baseline in C-reactive protein level
Time frame: Baseline and final visit on Day 6.
Change from baseline in alanine aminotransferase level
Time frame: Baseline and final visit on Day 6.
Change from baseline in aspartate aminotransferase level
Time frame: Baseline and final visit on Day 6.
Change from baseline in total bilirubin level
Time frame: Baseline and final visit on Day 6.
Change from baseline in alkaline phosphatase level
Time frame: Baseline and final visit on Day 6.
Change from baseline in gamma-glutamyl transferase level
Time frame: Baseline and final visit on Day 6.
Change from baseline in blood urea nitrogen level
Time frame: Baseline and final visit on Day 6.
Change from baseline in serum creatinine level
Time frame: Baseline and final visit on Day 6.
Clinically significant changes in physical examination findings
Time frame: Baseline and final visit on Day 6.
Clinically significant 12-lead electrocardiogram abnormalities
Time frame: Baseline and final visit on Day 6.
Incidence of adverse events
Time frame: From the first dose through Day 6.
Incidence of serious adverse events
Time frame: From the first dose through Day 6.
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 12 Aug 2026.
- Individual participant dataSharing planned: No. Individual participant data will not be shared with other researchers. Study findings will be reported only in aggregate form.
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Safety and Performance Assessment of the Decongestant Seawater Spray Pocket Valve Enriched With Essential Oils in Patients With Acute Rhinitis Associated With Nasal Obstruction: "DEVALPO"
Acute Rhinitis, Nasal Obstruction
RecruitingObservational study
Performance and Safety Assessment of the Mechanical Decongestant Seawater Spray Enriched With Essential Oils From Laboratoires Gilbert in Patient With Acute Rhinitis Associated With Nasal Obstruction
Acute Rhinitis, Nasal Obstruction
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Chunjiang Huang principal investigator
Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
Jianping Liu principal investigator
Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
Jianchang He principal investigator
Yunnan Provincial Hospital of Traditional Chinese Medicine / The First Affiliated Hospital of Yunnan University of Chinese Medicine
10 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Yanlishuang Buccal Dropping Pills in people with Acute Pharyngitis, run by Beijing University of Chinese Medicine at 10 sites in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 12 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 12 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 10 sites in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Time to complete sore throat resolution (time frame: From the first dose until complete sore throat resolution, assessed up to Day 6.). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 12 Aug 2026.