Efficacy of combined extract of Nigella Sativa and Thymus Vulgaris on refractory seizures in children

Authors
Category Primary study
Registry of TrialsIranian Registry of Clinical Trials
Year 2016
INTERVENTION: contorol group: patients with age 3‐12 years receive 5cc of prepared placebo three times a day and patients with age >12 years receive 7.5 cc of prepared plasebo three times a day for two months. Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then the prepared extracts extract(115 mg of extract is found in 5 cc of prepared drug )with the same dosage as adjunctive therapy will be administrated for another two months. Intervention 1: intervention group: patients with age 3‐12 years receive 5cc of prepared extract(115 mg of extract is found in 5 cc of prepared drug) three times a day and patients with age >12 years receive 7.5 cc of prepared extract three times a day for two months. Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then the prepared placebo will be administrated foranother two months. Intervention 2: contorol group: patients with age 3‐12 years receive 5cc of prepared placebo three times a day and patients with age >12 years receive 7.5 cc of prepared plasebo three times a day for two months. Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then the prepared extracts extract(115 mg of extract is found in 5 cc of prepared drug )with the same dosage as adjunctive therapy will be administrated for another two months. intervention group: patients with age 3‐12 years receive 5cc of prepared extract(115 mg of extract is found in 5 cc of prepared drug) three times a day and patients with age >12 years receive 7.5 cc of prepared extract three times a day for two months. Then all the patients will be evaluated for two weeks (as washout period) after two months in the terms of duration and the frequency of epilepsy and side effects. Then the prepared placebo will be administrated foranother two months. Treatment ‐ Drugs CONDITION: epilepsy. ; Episodic and paroxysmal disorders Episodic and paroxysmal disorders G40,G41 PRIMARY OUTCOME: Seizure duration. Timepoint: two months prior to study‐five months during study. Method of measurement: visitable seizure scaling. Seizures frequency per week. Timepoint: two months prior to study‐five months during study. Method of measurement: visitable seizure scaling. SECONDARY OUTCOME: Side effets. Timepoint: five months. Method of measurement: visitable scaling. INCLUSION CRITERIA: Inclusion criteria : children with a diagnosis of refractory seizures; having at least two episodes of seizures during one month prior to study entry; regular consumption of previous antiepileptic drugs. Exclusion criteria ; occurrence of adverse side effects such as nausea and vomiting; increase the number and duration of seizure after starting NS and TV; and dissatisfaction to continue participation in study.
Epistemonikos ID: 124124fb388df7d52622c7b9ec6aa38c486e3030
First added on: Apr 23, 2019