Clinical study of lingzhu powder on the prevention and treatment of children with (complex) febrile convulsion (acute severe attack wind heat dynamic wind syndrome)

Not Applicable

Recruiting

• Conditions: febrile seizure

• Registration Number: ITMCTR2100004641
• Lead Sponsor: The First Affiliated Hospital of He'nan University of 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: Recruiting
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Conform to the diagnostic criteria of febrile convulsion proposed in Expert Consensus on Diagnosis, Treatment and Management of Febrile Convulsion (2017) by Neurology Group of Pediatrics Society of Chinese Medical Association;
2. Meet the syndrome differentiation standards of Acute Severe Attack Wind Heat Dynamic Wind Syndrome in Guidelines for the Diagnosis and Treatment of Common Diseases in Pediatrics of Traditional Chinese Medicine issued by the State Administration of Traditional Chinese Medicine in 2012;
3. Convulsion more than 3 times in 6 months or 4 times in a year;
4. Aged from 6 months to 10 years; No gender limitations;
5. Received informed consent and volunteer to participate in the study.

Exclusion Criteria

1. Convulsions caused by central nervous system infection, epilepsy, toxic encephalopathy, metabolic disorders, acute intoxication or genetic metabolic diseases and other etiologies;
2. Patients without fever during convulsion;
3. Use of any investigational drug within 1 month or 10 half-periods prior to screening;
4. Patients who are known to be allergic to the components of Lingzhu powder;
5. Patients with a history of mental illness or congenital mental retardation;
6. Suffer from serious liver and kidney diseases, blood system diseases, malignant tumors, autoimmune diseases, chronic serious infections, etc..

Study & Design

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

Primary Outcome Measures

Name	Time	Method
electroencephalogram;renal function;liver function;MR;urine routine test;blood routine test;