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Ertong Qingyan Jiere Koufuye in the Treatment of Pediatric Acute Tonsillitis (syndrome/pattern of heat invading lung and stomach): A Randomized Double-Blind Parallel-Controlled Multicenter Clinical Trial

Ertong Qingyan Jiere Koufuye in the Treatment of Pediatric Acute Tonsillitis (syndrome/pattern of heat invading lung and stomach): A Randomized Double-Blind Parallel-Controlled Multicenter Clinical Trial

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
ITMCTR
Registry ID
ITMCTR2025000513
Enrollment
Unknown
Registered
2025-03-13
Start date
2025-04-01
Completion date
Unknown
Last updated
2025-04-07

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

Conditions

Pediatric Acute Tonsillitis (syndrome/pattern of heat invading lung and stomach)

Interventions

control group 1(Acute suppurative tonsillitis ):Basic treatment (cefuroxime axetil dry suspension)+10% crude dose of Ertong Qingyan Jiere Koufuye
experimental group 2(Acute catarrhal tonsillitis ):Ertong Qingyan Jiere Koufuye
experimental group 1(Acute suppurative tonsillitis ):Basic treatment (cefuroxime axetil dry suspension)+ Ertong Qingyan Jiere Koufuye
control group 2(Acute catarrhal tonsillitis ):10% crude dose of Ertong Qingyan Jiere Koufuye

Sponsors

Beijing Children's Hospital /Capital Medical University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
3 Years to 13 Years

Inclusion criteria

Inclusion criteria: (1) It meets the diagnostic criteria of Western medicine for acute tonsillitis in children; (2) It meets the syndrome differentiation standard of syndrome/pattern of heat invading lung and stomach in traditional Chinese medicine; (3) The age ranged from 3 to 13 years (<14 years); (4) Duration of sore throat = 48h; (5) WBS score of sore throat = 4; (6) Rapid streptococcal antigen (RADT) was negative in children with acute catarrhal tonsillitis; RADT was positive in children with acute suppurative tonsillitis; (7) <8 years old one legal guardian of the child gave informed consent and signed the informed consent form; = At the age of 8 the child and one legal guardian gave informed consent and signed the informed consent form

Exclusion criteria

Exclusion criteria: (1) It is caused by pharyngeal diphtheria scarlet fever Fanshang angina (ulcerative membranous angina) mononucleosis angina agranulocytosis angina and other diseases; (2) Those who have received antibiotics or antiviral treatment before enrollment or have used traditional Chinese medicine with the functions of clearing away heat and toxin reducing swelling and benefiting the throat which has a serious impact on the effectiveness evaluation according to the judgment of the researcher; (3) Those who have difficulty in understanding the WBS pain scale and cannot cooperate with the evaluator; (4) Children with acute otitis media acute sinusitis infectious laryngitis acute bronchitis pneumonia sepsis and other complications; (5) Children with a history of epilepsy or febrile seizures; (6) Patients with severe malnutrition rickets and severe primary diseases of heart brain liver kidney and hematopoietic system; (7) Glucose-6-phosphate dehydrogenase deficiency; (8) Allergic to the test drug and its components; (9) Other circumstances that the investigator considers unsuitable for participating in clinical trials

Design outcomes

Primary

MeasureTime frame
Disappearance rate/time of sore throat (days);

Secondary

MeasureTime frame
Disease efficacy (cure rate);Single symptom efficacy (disappearance rate);The curative effect of pharyngeal signs (normalization rate);Severity of sore throat;TCM syndrome curative effect (effective rate);Onset time of sore throat (days);Incidence of complications;

Countries

the People's Republic of China

Contacts

Public ContactXu Baoping

Beijing Children's Hospital /Capital Medical University

xubaopingbch@163.com13370115002

Outcome results

None listed

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