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
Sponsor:
Information provided by:
Shenzhen Children's Hospital
ClinicalTrials.gov Identifier:
NCT00796380
First received: November 21, 2008
Last updated: NA
Last verified: November 2008
History: No changes posted
  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
Endpoint Classification: Bio-availability Study
Intervention Model: Parallel Assignment
Masking: 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 ] [ 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:
    Drug: Xingnaojing
    injection
  Eligibility

Ages Eligible for Study:   1 Month to 18 Years
Genders Eligible for Study:   Both
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
Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the Contacts provided below. For general information, see Learn About Clinical Studies.

No Contacts or Locations Provided
  More Information

No publications provided

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
Study First Received: November 21, 2008
Last Updated: November 21, 2008
Health Authority: China: Ethics Committee

ClinicalTrials.gov processed this record on October 21, 2014