Clinical Study of Xingnaojing for the Treatment of Convulsive Diseases

November 21, 2008 updated by: Shenzhen Children's Hospital
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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

Study Type

Interventional

Enrollment (Anticipated)

1

Phase

  • Phase 4

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

1 month to 18 years (Child, Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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.

Study Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Supportive Care
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: None (Open Label)

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Time Frame
Antipyretic rate , Frequency of convulsive episodes ,
Time Frame: one year
one year
Frequency of convulsive episodes
Time Frame: 1 year
1 year

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Shenzhen Children's Hospital

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

December 1, 2008

Primary Completion (Anticipated)

November 1, 2009

Study Completion (Anticipated)

July 1, 2010

Study Registration Dates

First Submitted

November 21, 2008

First Submitted That Met QC Criteria

November 21, 2008

First Posted (Estimate)

November 24, 2008

Study Record Updates

Last Update Posted (Estimate)

November 24, 2008

Last Update Submitted That Met QC Criteria

November 21, 2008

Last Verified

November 1, 2008

More Information

Terms related to this study

Other Study ID Numbers

  • ChiCTR-TNC-00000097

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

Clinical Trials on Convulsive Diseases

Clinical Trials on Xingnaojing

Search Similar Trials

Sponsors and Collaborators

Medical Conditions

Drug Interventions

CROs by country

CROs in Benin

Conditions

Rare Diseases

Drug Interventions

Dietary Supplements

Sponsor/Collaborators

Locations

Subscribe