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Effect of vitamin E on oxidative stress in patients with epilepsy

Effect of vitamin E as an add-on therapy on oxidative stress in patients with epilepsy- A randomized placebo controlled trial

Status
Active, not recruiting
Phases
Phase 2
Study type
Interventional
Source
CTRI
Registry ID
CTRI/2022/04/041902
Enrollment
64
Registered
2022-04-19
Start date
Unknown
Completion date
Unknown
Last updated
2022-05-02

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

Health Condition 1: - Health Condition 2: G409- Epilepsy, unspecified

Interventions

Intervention1: Vitamin E capsules 400mg Comparator placebo starch 400mg: Patients will be given Vitamin E capsules 400mg or starch capsules 400mg Twice daily along with antiepileptic medication for a

Sponsors

JIPMER
Lead Sponsor

Eligibility

Inclusion criteria

Inclusion criteria: 1.Adult patients of age >=18 to 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

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

Design outcomes

Primary

MeasureTime frame
primary objectives 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 Timepoint: Antioxidant levels and oxidative stress markers will be assessed at baseline and every 2 months until the follow up period of 6months

Secondary

MeasureTime frame
To assess the EEG changes between both groupsTimepoint: This will be done at baseline and at 6 months

Countries

India

Contacts

Public ContactDr Anusha N

JIPMER

anushanatarajan29@gmail.com9659879322

Outcome results

None listed

Source: CTRI (via WHO ICTRP) · Data processed: Feb 4, 2026