Turmeric as Treatment in Epilepsy

Epilepsy Clinical Trial

Official title:

Turmeric as Treatment in Epilepsy

Clinical Trial Details — Status: Withdrawn

Administrative data

• NCT number: NCT03254680
• Other study ID #: 17-00750
• Status: Withdrawn
• Phase: N/A
• Start date: March 2018
• Est. completion date: November 2018

Study information

• Verified date: April 2018
• Source: New York University School of Medicine
• Contact: n/a
• Is FDA regulated: No
• Study type: Interventional

Clinical Trial 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.

Recruitment information / eligibility

• Status: Withdrawn
• Enrollment: 0
• Est. completion date: November 2018
• Est. primary completion date: November 2018
• Accepts healthy volunteers: No
• Gender: All
• Age group: 1 Year to 70 Years

Eligibility

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

Related Conditions & MeSH terms

• Dravet Syndrome
• Epilepsies, Myoclonic
• Epilepsy
• Focal Seizures
• Lennox Gastaut Syndrome
• Lennox-Gastaut Syndrome
• Seizures
• Syndrome
• Tuberous Sclerosis

Intervention

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

Locations

Country	Name	City	State
United States	New York University School of Medicine	New York	New York

Sponsors (1)

Lead Sponsor	Collaborator
New York University School of Medicine

Country where clinical trial is conducted

United States, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	3 months
Secondary	Number of epilepsy seizures post epilepsy treatment with turmeric		3 months