Development of an Indigenous Ketogenic Formula and Determination of its Efficacy, Safety and Tolerability in improving Seizure Outcome among Children with Drug Resistant Epilepsy

Development of an Indigenous Ketogenic Formula and Determination of its Efficacy, Safety and Tolerability in improving Seizure Outcome among A Cohort of Children with Drug Resistant Epilepsy in Tertiary Care Setting - Nil

Status

Active, not recruiting

Phases

Phase 2

Study type

Interventional

Source

CTRI

Registry ID

CTRI/2024/05/067973

Enrollment

Registered

2024-05-28

Start date

Unknown

Completion date

Unknown

Last updated

2026-03-30

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

Conditions

Health Condition 1: F01-F99- Mental, Behavioral and Neurodevelopmental disorders

Interventions

Intervention1: Children with Epilepsy (1month â?? 5 years) who are not controlled on anti seizure medications and those who are not willing for Epilepsy Surgery.: Duration of Supplementation - 4 month

Eligibility

Inclusion criteria

Inclusion criteria: Children with Epilepsy (1month â?? 5 years) who are not controlled on anti seizure medications and those who are not willing for Epilepsy Surgery.

Exclusion criteria

Exclusion criteria: Children with certain metabolic disorders such as defects in fatty acid oxidation, carnitine deficiency, and certain organic acidemias or those with history of pancreatitis, pre-existing liver conditions, gastrointestinal disorders and critically ill patients.

Design outcomes

Primary

Measure	Time frame
1. To develop indigenous, low cost and effective MCT based ketogenic formula which can be given orally as well as through NG feed. 2. To determine the efficacy of MCT based Ketogenic Diet in reducing the number of seizure episodes, achieving optimal ketosis and improving the urine ketone levels. 3. To determine the compliance, safety and tolerability of MCT based ketogenic diet by checking for any possible side effects. Timepoint: 6 months (For each child after 6 months of enrollment in the study primary outcome will be measured).	—

Measure

Time frame

1. To develop indigenous, low cost and effective MCT based ketogenic formula which can be given orally as well as through NG feed. 2. To determine the efficacy of MCT based Ketogenic Diet in reducing the number of seizure episodes, achieving optimal ketosis and improving the urine ketone levels. 3. To determine the compliance, safety and tolerability of MCT based ketogenic diet by checking for any possible side effects. Timepoint: 6 months (For each child after 6 months of enrollment in the study primary outcome will be measured).

—

Secondary

Measure	Time frame
nilTimepoint: nil	—

Countries

India

Contacts

Public ContactDr AJ Hemamalini

Sri Ramachandra Institute of Higher Education and Research

hemamalini.aj@sriramachandra.edu.in9841327708

Outcome results

None listed

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