Acute pharyngitis
Conditions
Interventions
Experimental group:Clear Throat Syrup, for oral use. Take 30ml each time, three times a day. The treatment course is 5 days.
Control group:Lan Qin Oral Liquid, for oral use. Take 10 ml each time, three times a day. The treatment course is 5 days.
Sponsors
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Eligibility
Sex/Gender
All
Age
18 Years to 80 Years
Inclusion criteria
Inclusion criteria: 1. Diagnosis of acute pharyngitis per Western medicine AND TCM pattern "wind-heat syndrome". 2. Male or female, aged 18–80 years (inclusive) on day of consent. 3. Sore throat onset = 4 on 0–10 cm visual analogue scale (VAS) at screening. 5. Able and willing to provide written informed consent; agrees to comply with all protocol-mandated visits, procedures and medication intake.
Exclusion criteria
Exclusion criteria: 1. Pregnant women, women intending to become pregnant or breastfeeding women. 2. Those with a body temperature of >= 38.5? or whose complete blood count shows a white blood cell count of > 10×10^9/L and an absolute neutrophil count of > 7.00×10^9/L. 3. Those with abnormal liver and kidney functions (including aspartate aminotransferase (AST) > 61.5 U/L, alanine aminotransferase (ALT) > 60 U/L, and serum creatinine (Scr) > 106 µmol/L). 4. Those with a history of clinically significant food, drug allergies or other allergic reactions (such as asthma, urticaria, eczema, etc.), especially those allergic to the test drug. 5. Those who have used any other type of medication for acute pharyngitis within 24 hours, including drugs for relieving sore throat (such as Chinese patent medicines, glucocorticoids, non-steroidal anti-inflammatory drugs, etc.) or those who need to take antibiotics or heat-clearing and detoxifying drugs due to other diseases, and those whose evaluation of the therapeutic effect is affected by the study investigator. 6. Those who have participated in other drug clinical trials within 1 month. 7. Those who, according to the study investigator's assessment, are not suitable to participate in this clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change from baseline in sore-throat VAS score at Day 5 post-treatment.; | — |
Secondary
| Measure | Time frame |
|---|---|
| Change from baseline in sore-throat VAS score at Day 3 post-treatment.;Time to complete resolution of sore throat;Time to first clinically meaningful reduction of sore throat;Overall response rate and markedly effective and cured rate at Day 3 and Day 5 post-treatment.; | — |
Countries
China
Contacts
Public ContactJunyan Wu
Sun Yat-sen Memorial Hospital,Sun Yat-sen University
Outcome results
None listed