Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases
The recruitment status of this study is unknown because the information has not been verified recently.
Verified November 2008 by Shenzhen Children's Hospital.
Recruitment status was Not yet recruiting
Information provided by:
Shenzhen Children's Hospital
First received: November 21, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
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.
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: Open Label
Primary Purpose: Supportive Care
||Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases
Primary Outcome Measures:
- Antipyretic rate , Frequency of convulsive episodes , [ Time Frame: one year ] [ Designated as safety issue: Yes ]
- Frequency of convulsive episodes [ Time Frame: 1 year ] [ Designated as safety issue: Yes ]
| Estimated Enrollment:
| Study Start Date:
| Estimated Study Completion Date:
| Estimated Primary Completion Date:
||November 2009 (Final data collection date for primary outcome measure)
|Ages Eligible for Study:
||1 Month to 18 Years
|Genders Eligible for Study:
|Accepts Healthy Volunteers:
- 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
- Frequent episodes of epilepsy: epilepsy episodes of all types; > 3 times / week
- Refractory epilepsy: no satisfactory efficacy after treatment by 2~3 antiepileptic drugs; ≥ 1 time / month
- Cerebral palsy: all types of cerebral palsy in children less than 3 years old. -
- Febrile convulsion: family history of epilepsy, complex type of febrile convulsion, epileptic episodes, febrile convulsion plus
- Frequent episodes of epilepsy: combined with advanced diseases
- Refractory epilepsy: epilepsy combined with advanced diseases
- Cerebral palsy: advanced diseases combined with backwardness or retardation of brain function development.
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No publications provided
ClinicalTrials.gov processed this record on March 03, 2015
||Epilepsy and cerebral palsy center, Shenzhen Children's Hospital, Shenzhen Children's Hospital
History of Changes
|Other Study ID Numbers:
|Study First Received:
||November 21, 2008
||November 21, 2008
||China: Ethics Committee