Back to resultsTurmeric as Treatment in Epilepsy
Primary Purpose
Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome
Status
Withdrawn
Phase
Not Applicable
Locations
United States
Study Type
Interventional
Intervention
Turmeric
Sponsored by
About this trial
This is an interventional treatment trial for Epilepsy focused on measuring Turmeric Oil, antiseizure medications, ar-turmerone
Eligibility Criteria
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
Sites / Locations
- New York University School of Medicine
Arms of the Study
Arm 1
Arm Type
Experimental
Arm Label
Turmeric Oil
Arm Description
stable dose of orally administered turmeric oil
Outcomes
Primary Outcome Measures
Number of epilepsy patients enrolled in study
feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.
Secondary Outcome Measures
Number of epilepsy seizures post epilepsy treatment with turmeric
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT03254680
Brief Title
Turmeric as Treatment in Epilepsy
Official Title
Turmeric as Treatment in Epilepsy
Study Type
Interventional
2. Study Status
Record Verification Date
April 2018
Overall Recruitment Status
Withdrawn
Why Stopped
Funding
Study Start Date
March 2018 (Anticipated)
Primary Completion Date
November 2018 (Anticipated)
Study Completion Date
November 2018 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
NYU Langone Health
4. Oversight
Studies a U.S. FDA-regulated Drug Product
No
Studies a U.S. FDA-regulated Device Product
No
Product Manufactured in and Exported from the U.S.
No
Data Monitoring Committee
No
5. Study Description
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Epilepsy, Dravet Syndrome, Lennox-Gastaut Syndrome, Tuberous Sclerosis, Focal Seizures
Keywords
Turmeric Oil, antiseizure medications, ar-turmerone
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Single Group Assignment
Masking
None (Open Label)
Allocation
N/A
Enrollment
0 (Actual)
8. Arms, Groups, and Interventions
Arm Title
Turmeric Oil
Arm Type
Experimental
Arm Description
stable dose of orally administered turmeric oil
Intervention Type
Dietary Supplement
Intervention Name(s)
Turmeric
Intervention Description
Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.
Primary Outcome Measure Information:
Title
Number of epilepsy patients enrolled in study
Description
feasibility of recruiting patients into a prospective study designed to evaluate the effect of orally ingested turmeric oil on seizures.
Time Frame
3 months
Secondary Outcome Measure Information:
Title
Number of epilepsy seizures post epilepsy treatment with turmeric
Time Frame
3 months
10. Eligibility
Sex
All
Minimum Age & Unit of Time
1 Year
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Manisha Holmes, MD
Organizational Affiliation
NYU Langone Health
Official's Role
Principal Investigator
Facility Information:
Facility Name
New York University School of Medicine
City
New York
State/Province
New York
ZIP/Postal Code
10016
Country
United States
12. IPD Sharing Statement
Plan to Share IPD
Undecided
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Turmeric as Treatment in Epilepsy
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