Clinical Efficacy Evaluation of Traditional Chinese Medicine Combined with Antibiotics in the Treatment of Acute Tonsillitis in Children

Status

Active, not recruiting

Phases

Early Phase 1

Study type

Interventional

Source

ITMCTR

Registry ID

ITMCTR2000002906

Enrollment

Unknown

Registered

2020-01-08

Start date

2020-01-20

Completion date

Unknown

Last updated

2023-02-20

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

Conditions

Acute Tonsillitis in Children

Interventions

Experimental Group 2:Basic treatment and Jieduliyanfang granule

Experimental Group 1:Basic treatment and Yinqiaosan granule

Control Group 1:Basic treatment and Yinqiaosan granules placebo

Control Group 1: Basic treatment and Jieduliyanfang granule placebo

Eligibility

Sex/Gender

All

Age

5 Years to 15 Years

Inclusion criteria

Inclusion criteria: (1) Meet the diagnostic criteria of acute tonsillitis in traditional Chinese medicine and western medicine;diagnostic criteria of western medicine:Clinical Practice Guidelines for the Diagnosis and Treatment of Acute Tonsillitis in Children (formulated in 2016), by Pediatric Otolaryngology Committee of Pediatrician Branch of Chinese Physicians Association; Diagnostic criteria of traditional Chinese medicine: refer to Guidelines for the Diagnosis and Treatment of Common Pediatric Diseases of Traditional Chinese Medicine (China Association of Traditional Chinese Medicine,2012);TCM syndrome standard: Refer to infant Rue whose syndrome are wind heat causes lung syndrome and lung stomach heat syndrome in Guidelines for the Diagnosis and Treatment of Common Pediatric Diseases of Traditional Chinese Medicine (China Association of Traditional Chinese Medicine,2012). (2) Onset time = 38 degree C. (4) The tonsil swollen I-III degrees, tonsil is congestive and swollen, or purulent exudate is seen. (5) Increased white blood cell count, percentage of neutrophils and c-reactive protein in peripheral blood (white blood cell count in peripheral blood is higher than 12 x 10^9/L or percentage of neutrophils is higher than 70%). (6) Aged is from 5 to 15 years. (7) The parent of the subject shall sign the informed consent (children aged 6 and above shall sign the informed consent) and be able to cooperate. (8) Outpatient or inpatient children are allowed.

Exclusion criteria

Exclusion criteria: (1) Except recurrent acute tonsillitis. (2) Excluding Vincent pharyngitis. (3) Except scarlet fever. (4) Excluding agranulocytic pharyngitis. (5) Excluding leukemic pharyngitis. (6) Except those with pyohemia. (7) Patients with measles, influenza and infectious mononucleosis. (8) Patients with severe primary diseases of the heart, liver, kidney, endocrine system and hematopoietic system. (9) Patients who are allergic to the test drug or allergic constitution (persons who are allergic to 2 or more foods or drugs). Patients who meet any of the above criteria shall be excluded.

Design outcomes

Primary

Measure	Time frame
Clinical cure rate;Antibiotic application days;Improvement rate;	—

Secondary

Measure	Time frame
Time when the total number of white blood cells returne to normal;Time for relief of sore throat;Time to return to normal for neutrophils percentage;Time when CRP returns to normal;Effect time of antipyretic;	—

Countries

China

Contacts

Public ContactXiaozheng Duan

2547723712@qq.com+86 15843092631

Outcome results

None listed

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