]>
IRCT20190406043175N10 IRCT 2024-04-09 Mashhad University of Medical Sciences The effect of parthenium Tanacetum on epilepsy Effect of parthenium Tanacetum essential oil on on reducing the number of seizures in children with treatment-resistant epilepsy 2024-04-02 anticipated 64 Complete https://irct.ir/trial/76167 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: 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, Blinding description: 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. 2-3 Drug-resistant epilepsy. Intervention group: parthenium Tanacetum plant essential oil will be prepared by the Pharmacological Research Center of Medicinal Plants, and after the preparation of the essential oil, small necklaces will be prepared for children, which have a small compartment of 2 x 1 x 0.5, and a high-density sponge is placed inside it. One drop of essential oil with 100% concentration is poured on the sponge three times a day. The child will be exposed to the smell of essential oil continuously for 24 hours.. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Hassan Rakhshandeh
Mashhad University of Medical Sciences, Azadi square
mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2259 rakhshandehh@mums.ac.ir Mashhad University of Medical Sciences scientific Hassan Rakhshandeh
Mashhad University of Medical Sciences, Azadi square
Mashhad Iran (Islamic Republic of) 9177948564 +98 51 3800 2259 rakhshandehh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) children aged 2-18 years who refer to the clinic or neurology department of Qaim Hospital and treatment-resistant epilepsy clinic Epilepsy (based on clinical findings and brain scan) is defined in such a way that despite receiving medication, their seizures are not controlled and are resistant to treatment. 2 years 18 years Both Presence of underlying metabolic disorder Existence of systemic diseases Allergy to chamomile Respiratory sensitivity leading to mouth breathing Non-continuous use of the essential oil used in the research Intensification of convulsions for any reason that requires a change in medication Epilepsy Episodic and paroxysmal disorders(G40-G47) Treatment - Drugs Intervention group: parthenium Tanacetum plant essential oil will be prepared by the Pharmacological Research Center of Medicinal Plants, and after the preparation of the essential oil, small necklaces will be prepared for children, which have a small compartment of 2 x 1 x 0.5, and a high-density sponge is placed inside it. One drop of essential oil with 100% concentration is poured on the sponge three times a day. The child will be exposed to the smell of essential oil continuously for 24 hours. Frequency of epilepsy attack. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Questionnaire. Diversity of epilepsy attack. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Questionnaire. Duration of epilepsy attack. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Questionnaire. Time of epileptic attacks. Timepoint: Early intervention, four weeks after the intervention, eight weeks after intervention. Method of measurement: Questionnaire. Mashhad University of Medical Sciences Approved 2024-03-08 Ethics committee of Mashhad University of Medical Sciences Mashhad University of Medical Sciences, Azadi Square, Mashhad Mashhad Razavi Khorasan Iran (Islamic Republic of)