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IRCT20211206053308N1 IRCT 2022-03-19 Ahvaz University of Medical Sciences Effect of Nigella Sativa on tremor Effectiveness of soft gel Nigella Sativa on tremor in patients with multiple sclerosis referred to the MS association of khuzestan province 2021-12-22 anticipated 32 Complete https://irct.ir/trial/60520 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Block randomization will be used in this study. The randomization list will be placed in closed envelopes by an out-of-study person according to the corresponding codes; it is then will be assigned to each patient who will enter the study.The distribution of patients will be done in a ratio of 1: 1 and by 8 blocks (the length of each block is 4), (sample size of this study is 32).The randomization sequence will be created using the randomization command in Excel (randbetween), Blinding description: In this study, two groups, including participants and the researcher, are kept blind. To do this, the interventions used in this study were randomized according to the list; Placed in closed envelopes by an out-of-study person according to the corresponding codes; It is then assigned to each patient who enters the study. All patients will continue their treatment regimen as before. Also, two drugs, black seed soft capsule and placebo soft capsule, are prepared in the same package, so that they do not differ in appearance. 3 Multiple sclerosis. Intervention 1: Intervention group: Use soft capsule Nigella sativa 500 mg, Parnian Darman Company, every 12 hours for 6 weeks. Intervention 2: Control group: Use the placebo soft capsule every 12 hours for 6 weeks. Yes - There is a plan to make this available What will be shared: All data can potentially be shared after unidentified individuals. When: Start of access period from 1402 To whom: Study data is available to anyone who applies for it. Conditions: Study data are available to researchers in similar or related studies Where to obtain: Nastaran Majdi Nasab, e-mail: n.majdi@ajums.ac.ir Leila Kooti, ​​e-mail: kouti-I@ajums.ac.ir Mohammad Mehravar, e-mail: mehravar-m@ajums.ac.ir Zahra Beigi, Email: zahrabeygi90@gmail.com How to obtain: The initial written request should be sent with a complete and clear explanation to determine the purpose of using the data, which will be made available to the applicant after reviewing the request for unidentifiable personal data. Comments:
public zahra beigi
West Shahrivar, Ahvaz Town
Ahvaz Iran (Islamic Republic of) 6135945431 +98 61 3374 3001 zahrabeygi90@gmail.com Ahvaz University of Medical Sciences scientific zahra beygi
West Shahrivar, AhvazTown
Ahvaz Iran (Islamic Republic of) 6135945431 +98 61 3374 3001 zahrabeygi90@gmail.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Having a proven MS condition based on clinical examination and medical history Confirmation of tremor based on neurologist approval based on clinical criteria Having an EDSS score between 2 and 6 Having fixed and regular consumption of medication in the last 3 months Consent to not use alternative drugs from 7 days before the intervention until the end of the intervention No attending to another study at the same time no limit no limit Both History of alcohol use or substance abuse Pregnancy or breastfeeding Impaired renal or hepatic function Steroid treatment during the month before the start of the study Having a neurological disease in addition to MS Heart disease or bleeding disorders Existence of allergy to Nigella Sativa The onset of the disease in the last month Treatment - Drugs Placebo Intervention group: Use soft capsule Nigella sativa 500 mg, Parnian Darman Company, every 12 hours for 6 weeks. Control group: Use the placebo soft capsule every 12 hours for 6 weeks. Tremor Amplitude. Timepoint: Tremor amplitude measurement at the beginning of the study and six weeks after taking soft capsule Nigella Sativa. Method of measurement: Video motion recording system. Tremor frequency. Timepoint: Tremor frequency measurement at the beginning of the study and six weeks after taking soft capsule Nigella Sativa. Method of measurement: Video motion recording system. Quality of life. Timepoint: At the beginning of the study and six weeks after taking soft capsule Nigella Sativa. Method of measurement: Questionnaire quality of life. Frequency of drug side effects. Timepoint: At the beginning of the study and six weeks after taking soft capsule Nigella Sativa. Method of measurement: Questionnaire. Ahvaz University of Medical Sciences Approved 2021-12-01 Ethics committee of Ahvaz University of Medical Sciences West Shahrivar, Ahvaz Town Ahvaz Khouzestan Iran (Islamic Republic of)