Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

Shenzhen Children's Hospital

Status and phase: Unknown; Phase 4

Conditions: Convulsive Diseases

Treatments: Drug: Xingnaojing

Study type: Interventional

Funder types: Other

Identifiers

NCT00796380

ChiCTR-TNC-00000097

Details and patient eligibility

About

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.

Enrollment: 1 estimated patient

Sex: All

Ages: 1 month to 18 years old

Volunteers: No Healthy Volunteers

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.

Trial design

Primary purpose: Supportive Care

Allocation: Randomized

Interventional model: Parallel Assignment

Masking: None (Open label)