Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

This study is not yet open for participant recruitment.

Verified by Shenzhen Children's Hospital, November 2008

Sponsored by:	Shenzhen Children's Hospital
Information provided by:	Shenzhen Children's Hospital
ClinicalTrials.gov Identifier:	NCT00796380

Purpose

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.

Condition	Intervention	Phase
Convulsive Diseases	Drug: Xingnaojing	Phase IV

U.S. FDA Resources

Study Type:	Interventional
Study Design:	Supportive Care, Randomized, Open Label, Parallel Assignment, Bio-availability Study
Official Title:	Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

Further study details as provided by Shenzhen Children's Hospital:

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:	1
Study Start Date:	December 2008
Estimated Study Completion Date:	July 2010
Estimated Primary Completion Date:	November 2009 (Final data collection date for primary outcome measure)

Intervention Details:

injection

Eligibility

Ages Eligible for Study:	1 Month to 18 Years
Genders Eligible for Study:	Both
Accepts Healthy Volunteers:	No

Criteria

Inclusion Criteria:

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. -

Exclusion Criteria:

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.

Contacts and Locations

No Contacts or Locations Provided

More Information

Responsible Party:	Shenzhen Children's Hospital ( Epilepsy and cerebral palsy center, Shenzhen Children's Hospital )
Study ID Numbers:	ChiCTR-TNC-00000097
Study First Received:	November 21, 2008
Last Updated:	November 21, 2008
ClinicalTrials.gov Identifier:	NCT00796380
Health Authority:	China: Ethics Committee

ClinicalTrials.gov processed this record on February 06, 2009