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

Phase 1

• Conditions: Acute Tonsillitis in Children

• Registration Number: ITMCTR2000002906
• Lead Sponsor: Affiliated Hospital of Changchun University of Traditional Chinese Medicine

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

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 <= 48 hours.
(3) Maximum body temperature >= 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

(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.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Clinical cure rate;Antibiotic application days;Improvement rate;

Secondary Outcome Measures

Name	Time	Method
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;