Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

NCT ID: NCT00796380

Last Updated: 2008-11-24

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

UNKNOWN

Clinical Phase

PHASE4

Total Enrollment

1 participants

Study Classification

INTERVENTIONAL

Study Start Date

2008-12-31

Study Completion Date

2010-07-31

Brief Summary

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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

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Conditions

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Convulsive Diseases

Study Design

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Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

SUPPORTIVE_CARE

Blinding Strategy

NONE

Interventions

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Xingnaojing

injection

Intervention Type DRUG

Eligibility Criteria

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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.
Minimum Eligible Age

1 Month

Maximum Eligible Age

18 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Shenzhen Children's Hospital

OTHER_GOV

Sponsor Role lead

Responsible Party

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Shenzhen Children's Hospital

Other Identifiers

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ChiCTR-TNC-00000097

Identifier Type: -

Identifier Source: org_study_id