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Turmeric as Treatment in Epilepsy

NCT ID: NCT03254680

Last Updated: 2018-04-30

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

WITHDRAWN

Clinical Phase

NA

Study Classification

INTERVENTIONAL

Study Start Date

2018-03-31

Study Completion Date

2018-11-30

Brief Summary

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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

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Conditions

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Epilepsy Dravet Syndrome Lennox-Gastaut Syndrome Tuberous Sclerosis Focal Seizures

Keywords

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Turmeric Oil antiseizure medications ar-turmerone

Study Design

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Allocation Method

NA

Intervention Model

SINGLE_GROUP

Primary Study Purpose

TREATMENT

Blinding Strategy

NONE

Study Groups

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Turmeric Oil

stable dose of orally administered turmeric oil

Group Type EXPERIMENTAL

Turmeric

Intervention Type DIETARY_SUPPLEMENT

Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.

Interventions

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Turmeric

Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.

Intervention Type DIETARY_SUPPLEMENT

Eligibility Criteria

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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.

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
Minimum Eligible Age

1 Year

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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NYU Langone Health

OTHER

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Manisha Holmes, MD

Role: PRINCIPAL_INVESTIGATOR

NYU Langone Health

Locations

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New York University School of Medicine

New York, New York, United States

Site Status

Countries

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United States

Other Identifiers

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17-00750

Identifier Type: -

Identifier Source: org_study_id