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An observational study for therapeutic drug monitoring of Phenytoin, Carbamazepine and Sodium valproate with the help of High Performance Liquid Chromatography (HPLC) machine.

â??Therapeutic Drug Monitoring of Phenytoin, Carbamazepine and Sodium Valproate in Patients with Epilepsy by High Performance Liquid Chromatography (HPLC) in A Tertiary Health Care Teaching Hospital: A Prospective Observational Studyâ??

Status
Active, not recruiting
Phases
Phase 4
Study type
Observational
Source
CTRI
Registry ID
CTRI/2016/10/007381
Enrollment
105
Registered
2016-10-18
Start date
Unknown
Completion date
Unknown
Last updated
2021-11-24

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

Conditions

Health Condition 1: null- Epilepsy

Interventions

None listed

Sponsors

Department of Pharmacology Government Medical College Bhavnagar
Lead Sponsor

Eligibility

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
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

MeasureTime frame
To correlate plasma concentration with seizure control. To correlate plasma concentration with pill count. To correlate plasma concentration with Adverse Drug Reaction. To find out possible factors for Sub-therapeutic and Toxic concentration. Timepoint: In morning OPD hours and in evening round ( 3days per week)for 1.5 year duration.

Countries

India

Contacts

Public ContactDr C B Tripathi

Government Medical College Bhavnagar

cbrtripathi@yahoo.co.in09825951678

Outcome results

None listed

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