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Turmeric as Treatment in Epilepsy

This study is not yet open for participant recruitment.
Verified November 2017 by New York University School of Medicine
Sponsor:
ClinicalTrials.gov Identifier:
NCT03254680
First Posted: August 18, 2017
Last Update Posted: November 14, 2017
The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
Information provided by (Responsible Party):
New York University School of Medicine
  Purpose
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.

Condition Intervention
Epilepsy Dravet Syndrome Lennox-Gastaut Syndrome Tuberous Sclerosis Focal Seizures Dietary Supplement: Turmeric

Study Type: Interventional
Study Design: Intervention Model: Single Group Assignment
Masking: None (Open Label)
Primary Purpose: Treatment
Official Title: Turmeric as Treatment in Epilepsy

Resource links provided by NLM:


Further study details as provided by New York University School of Medicine:

Primary Outcome Measures:
  • Number of epilepsy patients enrolled in study [ Time Frame: 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:
  • Number of epilepsy seizures post epilepsy treatment with turmeric [ Time Frame: 3 months ]

Estimated Enrollment: 20
Anticipated Study Start Date: March 2018
Estimated Study Completion Date: November 2018
Estimated Primary Completion Date: November 2018 (Final data collection date for primary outcome measure)
Arms Assigned Interventions
Experimental: Turmeric Oil
stable dose of orally administered turmeric oil
Dietary Supplement: Turmeric
Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.

  Eligibility

Information from the National Library of Medicine

Choosing to participate in a study is an important personal decision. Talk with your doctor and family members or friends about deciding to join a study. To learn more about this study, you or your doctor may contact the study research staff using the contacts provided below. For general information, Learn About Clinical Studies.


Ages Eligible for Study:   1 Year to 70 Years   (Child, Adult, Senior)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
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
  Contacts and Locations
Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03254680


Contacts
Contact: Oluwatobi Clement 646-558-0877 Oluwatobi.Clement@nyumc.org

Locations
United States, New York
New York University School of Medicine Not yet recruiting
New York, New York, United States, 10016
Contact: Oluwatobi Clement, MD    646-558-0877    Oluwatobi.Clement@nyumc.org   
Principal Investigator: Manisha Holmes, MD         
Sponsors and Collaborators
New York University School of Medicine
Investigators
Principal Investigator: Manisha Holmes, MD New York University School of Medicine
  More Information

Responsible Party: New York University School of Medicine
ClinicalTrials.gov Identifier: NCT03254680     History of Changes
Other Study ID Numbers: 17-00750
First Submitted: August 15, 2017
First Posted: August 18, 2017
Last Update Posted: November 14, 2017
Last Verified: November 2017
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Undecided

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

Keywords provided by New York University School of Medicine:
Turmeric Oil
antiseizure medications
ar-turmerone

Additional relevant MeSH terms:
Syndrome
Epilepsy
Seizures
Tuberous Sclerosis
Lennox Gastaut Syndrome
Epilepsies, Myoclonic
Disease
Pathologic Processes
Brain Diseases
Central Nervous System Diseases
Nervous System Diseases
Neurologic Manifestations
Signs and Symptoms
Hamartoma
Neoplasms
Neoplasms, Multiple Primary
Neoplastic Syndromes, Hereditary
Malformations of Cortical Development, Group I
Malformations of Cortical Development
Nervous System Malformations
Neurocutaneous Syndromes
Heredodegenerative Disorders, Nervous System
Neurodegenerative Diseases
Congenital Abnormalities
Genetic Diseases, Inborn
Turmeric extract
Antioxidants
Molecular Mechanisms of Pharmacological Action
Protective Agents
Physiological Effects of Drugs