Turmeric as Treatment in Epilepsy

Not Applicable

Withdrawn

• Conditions: Focal Seizures; Epilepsy; Lennox-Gastaut Syndrome; Dravet Syndrome; Tuberous Sclerosis
• Interventions: Dietary Supplement: Turmeric

• Registration Number: NCT03254680
• Lead Sponsor: NYU Langone Health

Brief Summary

This is a single center open-label pilot clinical trial of patients 1-70 years of age with greater than 6 seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures. Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months. Patients and caregivers will be asked to keep a seizure diary logging all clinical events during the course of the study. Serum comprehensive metabolic panel, complete blood count with differential, and antiseizure medication levels, will be monitored at baseline, 1.5 months, and at the end of 3 months.

Detailed Description

Not available

Study Timeline

• Study First Submitted: 2017-08-15
• Study First Submitted QC: 2017-08-16
• Study First Posted: 2017-08-18
• Study Start: 2018-03
• Status Verified: 2018-04
• Last Update Submitted: 2018-04-26
• Last Update Posted: 2018-04-30
• Primary Completion: 2018-11
• Study Completion: 2018-11

Recruitment & Eligibility

• Status: WITHDRAWN
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

• Patients with greater than greater than six seizures per month diagnosed with Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, or focal seizures followed at NYU CEC.

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Exclusion Criteria

• Patients expected to have changes to any medications or supplements during study period
• exposure to any investigational agent in the month prior to study entry
• pregnant or breast feeding women, positive pregnancy test
• history of non-compliance
• known drug or alcohol dependence
• known baseline hematologic
• liver function
• renal function
• absorption
• absorption

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Study & Design

• Study Type: INTERVENTIONAL
• Study Design: SINGLE_GROUP

Arm && Interventions

Group	Intervention	Description
Turmeric Oil	Turmeric	stable dose of orally administered turmeric oil

Primary Outcome Measures

Name	Time	Method
Number of epilepsy patients enrolled in study	3 months	feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.

Secondary Outcome Measures

Name	Time	Method
Number of epilepsy seizures post epilepsy treatment with turmeric	3 months

Trial Locations

Locations (1)

New York University School of Medicine; 🇺🇸 New York, New York, United States