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Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

The recruitment status of this study is unknown. The completion date has passed and the status has not been verified in more than two years.
Verified November 2008 by Shenzhen Children's Hospital.
Recruitment status was:  Not yet recruiting
Sponsor:
ClinicalTrials.gov Identifier:
NCT00796380
First Posted: November 24, 2008
Last Update Posted: November 24, 2008
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Read our disclaimer for details.
Information provided by:
Shenzhen Children's Hospital
  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 4

Study Type: Interventional
Study Design: 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

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

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

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:
    Drug: Xingnaojing
    injection
  Eligibility

Information from the National Library of Medicine

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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.
  Contacts and Locations
No Contacts or Locations Provided
  More Information

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 Submitted: November 21, 2008
First Posted: November 24, 2008
Last Update Posted: November 24, 2008
Last Verified: November 2008