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IRCT20211019052811N1 IRCT 2021-11-27 Mashhad University of Medical Sciences Evaluation of the effect of cannabidiol in the treatment of dystonia Evaluation of the effect of cannabidiol in the treatment of adult dystonias-a randomized placebo-controlled clinical trial 2021-11-22 anticipated 60 Complete https://irct.ir/trial/59499 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Randomization of patients in two groups is done using stratified randomization method. Due to the existence of two types of dystonia, we perform the block randomization method within each class. For this purpose, within each class, blocks with size a, b) aabb, abab, abba, baba, bbaa, baab) are randomly selected and patients Will be assigned to treatments according to this random sequence.To match the manual intensity in the treatment groups, for each intensity, a random sequence is created by blocking method with size 2 or 4, and the patients are assigned to the treatment group based on the obtained sequence.We use the tool for block randomization using the sealed envelope site, Blinding description: Patients receiving cannabidiol and placebo are blind to receiving the drug and the severity of motor symptoms is assessed by the researcher in relation to the type of blind intervention. 3 dystonia. Intervention 1: Intervention group:Liposomal cannabidiol drops are given at a dose of 10 mg every 6 hours. The drug is started with a dose of 10 mg every 12 hours (2 ml) and after 5 days is increased to a dose of 10 mg every 6 hours. Due to the divided dose of the drug, the patient will be more tolerant of the dose of the drug.The patient's previous treatments are reviewed and kept constant from one month before the end of the study.Patients receive the intervention for 9 weeks. Once before receiving the intervention and then at the end of the third, sixth and ninth week of the intervention, the severity of motor symptoms is measured by the researcher, who is blind to the type of intervention, based on the relevant movement scales in both groups.After the first period, it will be August 5 for 5 weeks and the intervention will be stopped in both groups. At the beginning of the second period, crossover is performed and patients who received the main drug in the first period will be assigned to the placebo group and those who received the placebo first will be assigned to the main drug group. The measurements will be performed in the same way as the first period. Intervention 2: Control group:Pharmacopoeia receive exactly the same drug as the main drug in the form of drops with the same color and taste as the main drug.Then, as in the intervention group, other actions are performed. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no more information
public Olfati Nahid
Ahmad Abad Ave,Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3859 6778 olfatin@mums.ac.ir Mashhad University of Medical Sciences scientific Nahid Olfati
Ahmad Abad Ave,Ghaem Hospital
Mashhad Iran (Islamic Republic of) 9176699199 +98 51 3840 0001 olfatin@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Patients with focal-generalized dystonia Failure to improve the patient's dystonic symptoms with previous drug treatments 18 years no limit Both Evidence that dystonia is secondary to other diseases History of liver disease Pregnancy or intent to conceive or breastfeed History of dystonic surgery, including deep brain stimulation and destructive surgery G24 Dystonia Treatment - Drugs Treatment - Drugs Intervention group:Liposomal cannabidiol drops are given at a dose of 10 mg every 6 hours. The drug is started with a dose of 10 mg every 12 hours (2 ml) and after 5 days is increased to a dose of 10 mg every 6 hours. Due to the divided dose of the drug, the patient will be more tolerant of the dose of the drug.The patient's previous treatments are reviewed and kept constant from one month before the end of the study.Patients receive the intervention for 9 weeks. Once before receiving the intervention and then at the end of the third, sixth and ninth week of the intervention, the severity of motor symptoms is measured by the researcher, who is blind to the type of intervention, based on the relevant movement scales in both groups.After the first period, it will be August 5 for 5 weeks and the intervention will be stopped in both groups. At the beginning of the second period, crossover is performed and patients who received the main drug in the first period will be assigned to the placebo group and those who received the placebo first will be assigned to the main drug group. The measurements will be performed in the same way as the first period. Control group:Pharmacopoeia receive exactly the same drug as the main drug in the form of drops with the same color and taste as the main drug.Then, as in the intervention group, other actions are performed Intensity of dystonia motion symptoms based on Van Marsden Scale and Global Dystonia Scale and TWSTRS. Timepoint: Before the intervention (0), then 3, 6, and 9 weeks after the start of the intervention or placebo. Method of measurement: Van Marsden Scale and Global Dystonia Scale and TWSTRS. Quality of life using SF-36 questionnaire. Timepoint: Before the intervention (0), then 3, 6, and 9 weeks after the start of the intervention or placebo. Method of measurement: SF-36 questionnaire. Mashhad University of Medical Sciences Approved 2021-10-19 Ethics committee of Mashhad University of Medical Sciences ŮŽAhmad Abad Ave,Hospital Ghaem Mashhad Razavi Khorasan Iran (Islamic Republic of)