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IRCT20220815055709N1 IRCT 2022-12-17 Khosro Medisa Teb Company The effect of using Cannabidiol on the severity of spasticity in MS patients with gait disorders Effects of oral cannabidiol (CBD) usage on variable severity of spasticity in multiple sclerosis patients with gait problem caused by their spasticity. A Double-Blind Randomised Controlled Trial 2023-01-21 anticipated 60 Complete https://irct.ir/trial/65313 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: According to the arrival time of the patients, the patient himself draws a number from 1 to 60. These numbers are defined by the main analyzer in the pre-prepared tables as placebo or the main drug. In addition, the arrangement of numbers and drugs has been randomized once by the main analyzer as a lottery. We have 60 patients divided into two groups (i.e. original drug and placebo). Therefore, out of 60 numbers, 30 numbers belong to patients (cases) and 30 numbers belong to controls. We write the name of the case or control on the paper and put them in an open box and randomly 60 patients choose them and do not see the result and give us the paper, Blinding description: Study participants will all be unaware of the group, despite being assured that they will be taking part in a study that will take either drug or placebo. Also, due to the completely similar label and specifications on the medicine bottle and placebo, the color, taste and consistency of the contents of the box are also completely blinded. Medicines are given in unmarked packages and shown to the clinical caregiver who is not in the process of treating the patients. 3 Spasticity in multiple sclerosis patients with gait problem. Intervention 1: Intervention group: MS patients are diagnosed with spasticity and the resulting gait disorder. These patients are randomly assigned to the intervention group according to the described conditions. The drug cannabidiol, which contains 40 milligrams per milliliter of CBD, was prepared by Khosro Medisa teb pharmaceutical company (KMT). In the first week, drug administration will start from 2.5 mg (twice a day) and up to 35 mg in the first week, and if there is no adequate response, it will be increased to the tolerance level and will be followed up to 8 weeks after the first intake. The medication should be taken using the graduated dropper included in the medication package, which will be fully explained by the person delivering the medicine. Intervention 2: Control group: patients diagnosed with MS with spasticity and the resulting gait disorder. These patients are randomly assigned to the control group according to the described conditions. The placebo prepared based on the special protocol of Khosro Medisa teb Pharmaceutical Company (KMT) is prepared as a liquid without medicinal substance (Cannabidiol-CBD). The drug consumption in the first week starts from 2.5 mg (twice a day) and goes up to 35 mg in the first week and is used up to 8 weeks after the first use. How to take the medicine, which is in liquid form, should be fully explained by the person providing the medicine, using the graduated dropper built into the closed medicine. Yes - There is a plan to make this available What will be shared: The data of the study participants will be evaluated for statistical analysis, and their results will be published in the form of an article. When: Immediately after the publication of the results in the form of a scientific article, the results of data analysis will be available to researchers at the request of the data. To whom: Researchers of this project and individuals who have the right to access the project data based on the written permission of the corresponding researcher can access the project data. Conditions: If the permission of the main researcher of the project is obtained with an acceptable justification and explanation, the data obtained from this project can be used. Where to obtain: MS Clinic, Ghaem Hospital Mashhad How to obtain: A written request will be sent to the researcher in charge of the study with appropriate evidence and justification; Once approved by him, access to data and documents will be possible. Comments:
public Pegah Mousavi
Ghaem Hospital, Ahmadabad Street, Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9176699199 +98 21 3840 0001 Pegahmsv@gmail.com Ghaem Hospital Mashhad scientific Mohammad Ali Nahayati
Ghaem Hospital, Ahmadabad Street, Mashhad, Khorasan Razavi
Mashhad Iran (Islamic Republic of) 9176699199 +98 21 3840 0001 NahayatiA@mums.ac.ir Ghaem Hospital Mashhad Iran (Islamic Republic of) Diagnosis of MS based on McDonald's 2017 criteria by a neurologist Expanded Disability Status Scale lower than (EDSS<7) Patients with gait disorder Age above 18 years 18 years no limit Both History of any liver dysfunction Known sensitivity to any component of the drug Taking drugs with liver metabolism such as Warfarin, Clobazam, and Sodium valproate Pregnancy or breastfeeding Use of marijuana or cannabis-derived compounds in the last 6 months G35 Multiple sclerosis Treatment - Drugs Treatment - Drugs Intervention group: MS patients are diagnosed with spasticity and the resulting gait disorder. These patients are randomly assigned to the intervention group according to the described conditions. The drug cannabidiol, which contains 40 milligrams per milliliter of CBD, was prepared by Khosro Medisa teb pharmaceutical company (KMT). In the first week, drug administration will start from 2.5 mg (twice a day) and up to 35 mg in the first week, and if there is no adequate response, it will be increased to the tolerance level and will be followed up to 8 weeks after the first intake. The medication should be taken using the graduated dropper included in the medication package, which will be fully explained by the person delivering the medicine. Control group: patients diagnosed with MS with spasticity and the resulting gait disorder. These patients are randomly assigned to the control group according to the described conditions. The placebo prepared based on the special protocol of Khosro Medisa teb Pharmaceutical Company (KMT) is prepared as a liquid without medicinal substance (Cannabidiol-CBD). The drug consumption in the first week starts from 2.5 mg (twice a day) and goes up to 35 mg in the first week and is used up to 8 weeks after the first use. How to take the medicine, which is in liquid form, should be fully explained by the person providing the medicine, using the graduated dropper built into the closed medicine. The severity of spasticity in Multiple sclerosis patients with gait problem following the use of Cannabidiol. Timepoint: The severity of the patient's spasticity before starting the drug and after 3 and 6 weeks from the start. Method of measurement: Severity of spasticity will be measured based on Numeric rating scale (0-10). Quality of patient's life. Timepoint: The patient's quality of life will be measured before and after 8 weeks of the intervention. Method of measurement: Patient quality of life will be measured using The European Quality of Life scale. The severity of the patient's gait problem. Timepoint: The severity of the patient's gait disorder will be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: The severity of the patient's gait problem using a SF12 short questionnaire with 12 questions. Sleep quality. Timepoint: Sleep quality will also be measured at the beginning and after 6 weeks from the beginning of the study. Method of measurement: Sleep quality will be measured using a SF12 short questionnaire with 12 questions. The severity of pain. Timepoint: The severity of pain of the patients will also be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: Pain of the patients using a SF12 short questionnaire with 12 questions. Patients' Urinary disorders. Timepoint: Urinary disorders of the patients will be measured at the beginning and after 6 weeks from the start of the study. Method of measurement: urinary disorders of the patients will be measured using a SF12 short questionnaire with 12 questions. Khosro Medisa Teb Company Approved 2022-06-14 Faculty of Medicine, Mashhad University of Medical Sciences Mashhad Faculty of Medicine, Eastern Door of University Campus, Azadi Square, Mashhad, Khorasan Razavi Mashhad Razavi Khorasan Iran (Islamic Republic of)