Study of outcome of Prednisolone with Vitamin B12 versus without steroids in the treatment of west syndrome
Phase 4
- Conditions
- Health Condition 1: G404- Other generalized epilepsy and epileptic syndromes
- Registration Number
- CTRI/2020/10/028214
- Lead Sponsor
- one
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.CHILDREN PRESENTING WITH INFANTILE SPASMS
2.INTERICTAL EEG SHOWING HYPSARRHYTHMIA
3.WITH OR WITHOUT DEVELOPMENTAL DELAY
Exclusion Criteria
1.CHILDREN WITH WEST SYNDROME SECONDARY TO TUBEROUS SCLEROSIS,BIOTIN DEFICIENCY , PYRIDOXINE DEFICIENCY
2.CHILDREN IN WHOM STEROIDS ARE CONTRAINDICATED LIKE INFECTIONS AND HYPERTENSION
3.WHO HAVE ALREADY RECEIVED TREATMENT WITH ACTH AND OTHER STEROIDS
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.CESSATION OF SPASMS <br/ ><br>2.NO RESPONSE:50% CESSATION <br/ ><br>3.PARTIAL RESPONSE :50-100%CESSATION <br/ ><br>4.COMPLETE RESPONSE :100%CESSATIONTimepoint: 2 WEEKS
- Secondary Outcome Measures
Name Time Method 1.RESOLUTION OF EEG ABNORMALITY <br/ ><br>2.RELAPSE RATES OF SPASMS <br/ ><br>3.SIDE EFFECTS:WEIGHT GAIN, HYPERTENSION ,INFECTIONS, GASTRITISTimepoint: 6 MONTHS