Effect of vitamin E on oxidative stress in patients with epilepsy
Phase 2
- Conditions
- Health Condition 1: - Health Condition 2: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2022/04/041902
- Lead Sponsor
- JIPMER
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
Inclusion Criteria
1.Adult patients of age >=18 to <=60 years of either gender.
2.Patients on Monotherapy with sodium valproate, Phenytoin, carbamazepine for at least a period of 6 months.
3.Patients with uncontrolled seizure (defined as having a seizure episode at least one per year when maintained on an adequate trial of antiepileptics)
Exclusion Criteria
1. Patients with other comorbidities like renal diseases and liver diseases
2. Patients already on treatment with Vitamin E.
3. Patients with structural brain diseases and space occupying lesions as diagnosed on appropriate imaging
4. Patients not willing to give written informed consent
5. Pregnant and lactating women
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method primary objectives <br/ ><br>1.To estimate the changes in antioxidant levels and oxidative stress markers in patients receiving vitamin E as add-on therapy and its impact on seizure free interval when compared with placebo <br/ ><br> <br/ ><br>Timepoint: Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months <br/ ><br>
- Secondary Outcome Measures
Name Time Method To assess the EEG changes between both groupsTimepoint: This will be done at baseline and at 6 months