Effect of vitamin E on oxidative stress in patients with epilepsy

Phase 2

Not yet recruiting

• Conditions: Epilepsy, unspecified,

• Registration Number: CTRI/2022/04/041902
• Lead Sponsor: JIPMER

Brief Summary

**1.**Epilepsy is one of the most common neurological disorders worldwide. With numerous treatment options the need for antiepileptics for a long term in many patients makes their quality of life distressing. One of the profound mechanisms is due to oxidative stress that plays a major role in development and progression of epileptogenesis. This can be combated by vitamin E an antioxidant Vitamin which shows effective reduction in seizure frequency and oxidative stress as evidenced from previous literature. The novelty of this study lies in the fact that Indian population has inherently high oxidative stress which is due to higher homocysteine levels in blood contributed by various genetic and dietary factors. This study uses this property of vitamin E to modify the course of disease in patients with epilepsy.

Detailed Description

Not available

Study Timeline

• Last Update Posted: 2022-02-04
• Study Start: 2022-06-25

Recruitment & Eligibility

• Status: Not Yet Recruiting
• Sex: All
• Target Recruitment: 64

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

• Patients with other comorbidities like renal diseases and liver diseases 2.
• Patients already on treatment with Vitamin E.
• 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	Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months
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	Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months

Secondary Outcome Measures

Name	Time	Method
To assess the EEG changes between both groups	This will be done at baseline and at 6 months

Trial Locations

Locations (1)

JIPMER; 🇮🇳 Pondicherry, PONDICHERRY, India

JIPMER

🇮🇳Pondicherry, PONDICHERRY, India

Anusha N

Principal investigator

9659879322

anushanatarajan29@gmail.com