Health Condition 1: G408- Other epilepsy and recurrent seizures
Conditions
Interventions
Intervention1: Melatonin as an add on therapy in the treatment of drug resistant epilepsy: 6mg and 9mg melatonin half an hour before sleep for 3 months in less than 9 years and more than 9 years of ch
Sponsors
DR SAMARENDRA MAHAPATRO
DR MUPPA VIKAS
Eligibility
Inclusion criteria
Inclusion criteria: 1.Age: children aged 2 year to 14 years. 2.Children with drug resistant epilepsy [ILAE,2017]
Exclusion criteria
Exclusion criteria: 1.Children with hepatic dysfunction 2.History of recent traumatic head injury 3.Children presented with status epilepticus 4.Children with history of allergy to valproate, melatonin or other melatonin agonists. 5.Children who are on melatonin products in last 3 months.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To measure the difference of decrease in seizure frequency by 25% in experimental group as compared to control group Timepoint: Difference will be assessed after 3 months of follow up after starting the study | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.To compare the number of antiepileptic drugs needed to control seizures in drug resistant seizure patients after adding melatonin as compared to control group 2.Adverse effects of melatonin. Timepoint: After adding melatonin as an add on therapy, weekly follow-up is done for 1st one month through telephonic consultation and then followed up in pediatric OPD every monthly for 3 months | — |
Countries
India
Contacts
Public ContactSAMARENDRA MAHAPATRO
AIIMS,BHUBANESWAR
Outcome results
None listed