A clinical trial to study the effect of vitamin B6 supplementation in persons with epilepsy
- Conditions
- Health Condition 1: G409- Epilepsy, unspecified
- Registration Number
- CTRI/2023/10/058835
- Lead Sponsor
- AIIMS New Delhi
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 0
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.
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.
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1.LAEP profile <br/ ><br>2.MINI score <br/ ><br>3.QOLIE score <br/ ><br>4.HDRS <br/ ><br>5.GAD7Timepoint: At the time of enrolment and at the end of 12 weeks
- Secondary Outcome Measures
Name Time Method Cost effectiveness will be comparedTimepoint: after opening the blinding at 10 months