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Clinical observation on the clinical efficacy and safety of combined Chinese and Western medicine therapy in the treatment of acute pharyngitis in children.

Clinical observation on the clinical efficacy and safety of combined Chinese and Western medicine therapy in the treatment of acute pharyngitis in children.

Status
Recruiting
Phases
Phase 4
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000117
Enrollment
Unknown
Registered
2025-01-15
Start date
2024-10-22
Completion date
Unknown
Last updated
2025-02-03

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

Conditions

Acute pharyngitis in children

Interventions

control:Standard treatment using western medicine. The course of treatment was 5 days. 1) Antipyretics and analgesics: ibuprofen suspension or acetamiphen as needed. 2) Antibacterial drugs: amoxicilli
experimental:Standard Western medical treatment was used in combination with ErTong QingYan JieRe KouFuYe. The course of treatment was 5 days.Usage and dosage follow the instructions.

Sponsors

Zhoukou Central Hospital
Lead Sponsor

Eligibility

Sex/Gender
All
Age
1 Years to 14 Years

Inclusion criteria

Inclusion criteria: 1) the child's legal guardian gave informed consent and signed an informed consent form; 2) meeting the Western medical diagnostic criteria for acute pharyngitis in children; 3) Comply with the TCM diagnostic criteria of syndrome/pattern of heat invading lung and stomach; 4) Age 1 to 14 years old gender is not limited; 5) Duration of illness = 48 hours; 6) WBS sore throat score =4; 7) Children with McIsaac score =2 (viral infection) or McIsaac score =3 (bacterial infection);

Exclusion criteria

Exclusion criteria: 1) Local complications such as retropharyngeal abscess parapharyngeal abscess and peritonsillar abscess acute otitis media acute rhinosinusitis acute laryngotracheitis acute bronchitis and even pneumonia. Rheumatic fever acute glomerulonephritis acute arthritis rheumatic fever cardiac complications etc; 2) Children with scarlet fever and serous disease; 3) children with combined measles infectious mononucleosis; 4) children with severe primary diseases of the heart liver kidney and hematopoietic system diabetes mellitus and mental illness; 5) Children who are allergic or hypersensitive to test drugs (allergic to 2 or more foods or drugs); 6) children with the following abnormal laboratory indicators: 1) abnormal renal function (blood creatinine SCr is greater than the upper limit of normal values); 2) glutamic oxal transaminase (AST) alanine aminotransferase (ALT) exceeds the upper limit of the normal value of more than 50% (1.5 times); 3) clinically significant cardiac arrhythmia; 7) Children with malignant tumors; 8) Children who have participated in other clinical observations within the last 1 month; 9) Children who in the opinion of the investigator are not suitable for clinical observation. Children who meet any of the above criteria should be excluded.

Design outcomes

Primary

MeasureTime frame
Time to onset of sore throat relief (WBS);

Secondary

MeasureTime frame
number of days of antibiotic use;efficacy of TCM syndrome manifestation.;Analysis of decline in single symptom scoring;Number of antipyretic and analgesic administrations.;total leukocyte count, neutrophil percentage, and C-reactive protein level.;

Countries

the People's Republic of China

Contacts

Public ContactZhenlin Ma

Zhoukou Central Hospital

596649530@qq.com13803948603

Outcome results

None listed

Source: ITMCTR (via WHO ICTRP) · Data processed: Feb 4, 2026