Turmeric as Treatment in Epilepsy

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Postavenie

Sponzori

NYU Langone Health

KLINICKÁ ŠTÚDIA: NCT03254680

BioSeek: nct03254680

Kľúčové slová

Abstrakt

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.

Termíny

Naposledy overené:	03/31/2018
Prvý príspevok:	08/14/2017
Odhadovaná registrácia bola odoslaná:	08/15/2017
Prvý príspevok:	08/17/2017
Posledná aktualizácia bola odoslaná:	04/25/2018
Posledná aktualizácia bola zverejnená:	04/29/2018
Aktuálny dátum začatia štúdie:	02/28/2018
Odhadovaný dátum dokončenia primárneho okruhu:	10/31/2018
Odhadovaný dátum dokončenia štúdie:	10/31/2018

Stav alebo choroba

Epilepsy

Dravet Syndrome

Lennox-Gastaut Syndrome

Tuberous Sclerosis

Focal Seizures

Intervencia / liečba

Dietary Supplement: Turmeric Oil

Fáza

Skupiny zbraní

Arm	Intervencia / liečba
Experimental: Turmeric Oil stable dose of orally administered turmeric oil	Dietary Supplement: Turmeric Oil Twenty patients will be enrolled and treated with a stable dose of orally administered turmeric oil daily for 3 months.

Kritériá oprávnenosti

Vek vhodný na štúdium	1 Year To 1 Year
Pohlavia vhodné na štúdium	All
Prijíma zdravých dobrovoľníkov	Áno
Kritériá	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

Výsledok

Primárne výstupné opatrenia

1. 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.

Opatrenia sekundárnych výsledkov

1. Number of epilepsy seizures post epilepsy treatment with turmeric [3 months]

Turmeric as Treatment in Epilepsy

Kľúčové slová

sclerosis

tuberózna skleróza

epilepsy

seizures

kurkuma