An observational study for therapeutic drug monitoring of Phenytoin, Carbamazepine and Sodium valproate with the help of High Performance Liquid Chromatography (HPLC) machine.
Phase 4
- Conditions
- Health Condition 1: null- Epilepsy
- Registration Number
- CTRI/2016/10/007381
- Lead Sponsor
- Department of Pharmacology Government Medical College Bhavnagar
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- ot Yet Recruiting
- Sex
- Not specified
- Target Recruitment
- 105
Inclusion Criteria
Patients of any age and both gender who are willing to give written inform consent.
In case of patients less than 18 years of age guardian must be there to provide written inform consent.
Patients on Anti-Epileptic treatment with Phenytoin, Carbamazepine or Sodium valproate and in combination therapy with any of these or other Anti-Epileptic drugs for six months or more.
Exclusion Criteria
Patients on Anti-Epileptic Drugs for less than six months.
Patients on these drugs for indication other than Epilepsy.
Patients with history of hepatitis-B OR hepatitis-C
Patient who do not give consent.
Study & Design
- Study Type
- Observational
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method To categorize plasma concentration of Anti-Epileptic Drugs according to Sub-therapeutic, Therapeutic, and Toxic concentration.Timepoint: In morning OPD hours and in evening round ( 3days per week)for 1.5 year duration.
- Secondary Outcome Measures
Name Time Method To correlate plasma concentration with seizure control. <br/ ><br>To correlate plasma concentration with pill count. <br/ ><br>To correlate plasma concentration with Adverse Drug Reaction. <br/ ><br>To find out possible factors for Sub-therapeutic and Toxic concentration. <br/ ><br>Timepoint: In morning OPD hours and in evening round ( 3days per week)for 1.5 year duration.