Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

Phase 4

• Conditions: Convulsive Diseases

• Registration Number: NCT00796380
• Lead Sponsor: Shenzhen Children's Hospital

Brief Summary

The purpose of this study is to evaluate the efficacy of Xingnaojing for the treatment of convulsive diseases; to investigate whether convulsion episodes can be induced or aggravated by Xingnaojing and the role inflammation plays in the process.

Detailed Description

Not available

Study Timeline

• Status Verified: 2008-11
• Study First Submitted: 2008-11-21
• Study First Submitted QC: 2008-11-21
• Last Update Submitted: 2008-11-21
• Study First Posted: 2008-11-24
• Last Update Posted: 2008-11-24
• Study Start: 2008-12
• Primary Completion: 2009-11
• Study Completion: 2010-07

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 1

Inclusion Criteria

1. Febrile convulsion: positive family history of febrile convulsion; aged between 6 months and 6 years old; in accordance with the diagnosis criteria of simple type of febrile convulsion
2. Frequent episodes of epilepsy: epilepsy episodes of all types; > 3 times / week
3. Refractory epilepsy: no satisfactory efficacy after treatment by 2~3 antiepileptic drugs; ≥ 1 time / month
4. Cerebral palsy: all types of cerebral palsy in children less than 3 years old. -

Exclusion Criteria

1. Febrile convulsion: family history of epilepsy, complex type of febrile convulsion, epileptic episodes, febrile convulsion plus
2. Frequent episodes of epilepsy: combined with advanced diseases
3. Refractory epilepsy: epilepsy combined with advanced diseases
4. Cerebral palsy: advanced diseases combined with backwardness or retardation of brain function development.

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Primary Outcome Measures

Name	Time	Method
Frequency of convulsive episodes	1 year
Antipyretic rate , Frequency of convulsive episodes ,	one year