Health Condition 1: G409- Epilepsy, unspecified
Conditions
Interventions
Intervention1: Pyridoxine: Pyridoxine or vitamin B6 100mg will be administered orally once daily for 12 weeks
Control Intervention1: Placebo: Matching placebo will be administered orally once daily fo
Sponsors
AIIMS New Delhi
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age more than or equal to 18 years. 2.Persons diagnosed with epilepsy on the basis of ILAE definition on Levetiracetam monotherapy(for not more than 3 months or newly prescribed). 3.Persons diagnosed with epilepsy on the basis of ILAE definition on Brivaracetam monotherapy(for not more than 3 months or newly prescribed). 4.Subjects willing to participate and able to provide written informed consent.
Exclusion criteria
Exclusion criteria: 1.persons who are unwilling to participate and do not provide written informed consent. 2.Persons who consume alcohol. 3.Pregnant and lactating women. 4.Persons with current or past diagnosis of mental illness or treatment related to the same. 5.Persons with uncontrolled hypertension, unstable heart disease or known case of myocardial infarction. 6.Persons with concurrent hepatic, renal or pulmonary dysfunction . 7.Persons with a current or past diagnosis of malignancy.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.LAEP profile 2.MINI score 3.QOLIE score 4.HDRS 5.GAD7Timepoint: At the time of enrolment and at the end of 12 weeks | — |
Secondary
| Measure | Time frame |
|---|---|
| Cost effectiveness will be comparedTimepoint: after opening the blinding at 10 months | — |
Countries
India
Contacts
Public ContactDr Sanskruti Rupayana
All India Institute of Medical Sciences
Outcome results
None listed