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Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

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ClinicalTrials.gov Identifier: NCT00796380
Recruitment Status : Unknown
Verified November 2008 by Shenzhen Children's Hospital.
Recruitment status was:  Not yet recruiting
First Posted : November 24, 2008
Last Update Posted : November 24, 2008
Sponsor:
Information provided by:
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.

Condition or disease Intervention/treatment Phase
Convulsive Diseases Drug: Xingnaojing Phase 4

Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 1 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Masking: None (Open Label)
Primary Purpose: Supportive Care
Official Title: Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases
Study Start Date : December 2008
Estimated Primary Completion Date : November 2009
Estimated Study Completion Date : July 2010

Intervention Details:
    Drug: Xingnaojing
    injection


Primary Outcome Measures :
  1. Antipyretic rate , Frequency of convulsive episodes , [ Time Frame: one year ]
  2. Frequency of convulsive episodes [ Time Frame: 1 year ]


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Ages Eligible for Study:   1 Month to 18 Years   (Child, Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.

Responsible Party: Epilepsy and cerebral palsy center, Shenzhen Children's Hospital, Shenzhen Children's Hospital
ClinicalTrials.gov Identifier: NCT00796380     History of Changes
Other Study ID Numbers: ChiCTR-TNC-00000097
First Posted: November 24, 2008    Key Record Dates
Last Update Posted: November 24, 2008
Last Verified: November 2008