Effect of parthenium Tanacetum essential oil on on reducing the number of seizures in children with treatment-resistant epilepsy

The aim of this study is to investigate the effect of parthenium Tanacetum essential oil on the clinical indicators of treatment-resistant epilepsy

Randomized double-blind, controlled clinical trial, parallel, phase 2-3 on 64 patients with resistant to epilepsy (32 patients in each group) using computer randomization method

64 patients with treatment-resistant epilepsy aged 2-18 years were included in the study and the questionnaire was filled. They will be monitored for 4 weeks while they continue their anti-epileptic drugs, and the variables of the number of attacks, the variety of attacks, the duration of each attack and the time of its occurrence will be recorded. After the end of four weeks, the patients are randomly and double blindly divided into two groups control and placebo. Both groups are given necklaces of the same shape, the same smell and the same color. And for another four-week period, the patients are monitored and the variables will be reviewed after four weeks. The study will take place at the Mashhad University of Medical Sciences, Mashhad, Iran.

children aged 2-18 years with treatment-resistant epilepsy- Epilepsy is defined in such a way that despite receiving medication, their seizures are not controlled and are resistant to treatment.

Parthenium Tanacetum plant essential oil will be prepared by the Pharmacological Research Center of Medicinal Plants, small necklaces will be prepared for children, which have a small compartment and a high-density sponge is placed inside it. One drop of essential oil will be poured on the sponge three times a day. The child will be exposed to the smell of essential oil continuously for 24 hours.

Improvement of clinical symptoms of epilepsy (number of attacks, variety of attacks, duration of each attack)

The randomization method will be done using online random sequence generators. The blocks will be consisting of four sites filled by letter A or B. The combination of letters A and B will generate six blocks as follow: AABB, ABBA, BBAA, BAAB, ABAB, BABA. A number between 1 to 6 will be selected randomly and the corresponding combination will be used to assign the patients. For example, if the number 3 came up, the block number 3 with the combination of “BAAB”, the assignment of first 4 patients will be assigned. For assignment remaining 60 patients in to 2 groups we will need 14 more blocks which will be selected as previously explained.

The blinding of randomized allocation will be done using closed envelopes method. the sequence of the patients will be placed inside a sealed envelope and upon arrival of the patient the envelope will be opened.