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A randomized, double-blind, placebo-controlled, parallel-group, multicenter phase III clinical study of Keganliyan Oral Liquid in the treatment of adult acute pharyngitis (with exterior wind-heat syndrome)

A randomized, double-blind, placebo-controlled, parallel-group, multicenter phase III clinical study of Keganliyan Oral Liquid in the treatment of adult acute pharyngitis (with exterior wind-heat syndrome)

Status
Recruiting
Phases
Phase 3
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2026000222
Enrollment
Unknown
Registered
2026-01-30
Start date
2025-11-05
Completion date
Unknown
Last updated
2026-03-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Acute Pharyngitis

Interventions

Experimental group:Kegan Liyan Oral Liquid,Oral administration, 20mL tid
Control group:Kegan Liyan Oral Liquid (placebo), Oral administration, 20mL tid

Sponsors

The First Affiliated Hospital of Guangzhou University of Chinese Medicine
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

Inclusion criteria: 1. Age between 18 and 65 years old, gender not restricted; 2. VAS score for pharyngeal pain ranging from 4 to 7 points; 3. Meets the diagnostic criteria of acute pharyngitis in Western medicine and the syndrome differentiation criteria of exogenous wind-heat syndrome in Traditional Chinese Medicine; 4. Body temperature = 38.5?, disease duration = 48 hours; 5. Voluntary participation and signing of informed consent form.

Exclusion criteria

Exclusion criteria: 1. Centor score = 2 points, white blood cell count in blood routine examination = 12×10^9/L, blood neutrophil percentage > 1.2×ULN, and subjects considered to have bacterial infection or requiring antibiotic treatment by the investigator; 2. Subjects with suppurative tonsillitis, pneumonia, bronchitis, otitis media, herpangina, viral myocarditis, acute nephritis, rheumatic arthritis, etc.; 3. Subjects with pharyngeal symptoms or inflammation caused by measles, scarlet fever, granulocytopenia, infectious mononucleosis, leukemia, etc.; 4. Subjects with severe primary diseases of the heart, brain, blood vessels, or hematopoietic system, where aspartate aminotransferase (AST), alanine aminotransferase (ALT) > 1.5 times the upper limit of normal, serum creatinine (Cr), and BUN > 1.5 times the upper limit of normal; 5. Subjects with malignant tumors, immunodeficiency, or those receiving immunosuppressive agents; 6. Subjects with a clear history of neurological or psychiatric disorders, alcohol dependence, or drug abuse, who, in the investigator's judgment, are unable to comply with treatment or follow medical advice; 7. Subjects who have already used other Chinese or Western medications for this condition or require antibiotics for other diseases since the onset of the current illness; 8. Pregnant women, those intending to become pregnant, or breastfeeding women; 9. Subjects with a history of allergy to multiple drugs (two or more) or known components of this medication; 10. Subjects who have participated in other drug clinical trials within the past 3 months or in medical device clinical trials within the past 1 month; 11. Subjects deemed unsuitable for participation in this clinical trial by the investigator.

Design outcomes

Secondary

MeasureTime frame
Rate of disappearance of sore throat;VAS score of sore throat;Time of onset of sore throat;Rate of producing analgesic effect;Rate of producing analgesic effect;TCM syndrome score change value;Single symptom score change value;Use of emergency drugs;

Primary

MeasureTime frame
Time of disappearance of sore throat;

Countries

China

Contacts

Public ContactYan Ruan

Guangdong Province, Guangzhou City, Baiyun District, Airport Road 16

ruanyan63@163.com13925037930

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Mar 14, 2026