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IRCT20211031052928N1 IRCT 2021-12-13 Tabriz University of Medical Sciences L-carnitine in patients with MS Evaluating the effect of L-carnitine supplement on fatigue severity in patients with multiple sclerosis 2021-12-22 anticipated 112 Complete https://irct.ir/trial/59711 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In order to uniformize the distribution of patients in the drug and placebo groups, a randomized blocking method will be used so that patients are evenly distributed in the study groups. At the end of the study, the relationship between different factors and fatigue in patients will be evaluated using multivariate logistic regression method. In this study, random allocation will be done by block randomization method with fixed size blocks with standard methods. The randomization steps will be as follows: 1- Creating a random sequence: Four random sequences for 4 blocks of 28 will be created using the RALLOC module in STATA software. 2- Allocation concealment Allocation coverage will be done using the method of closed matte envelopes with serial numbering. 3- Execution of allocation: The allocation will be performed by the person in charge of the clinical trial, Blinding description: In the present clinical trial study, the patient, physician, and researcher will be blinded to being placed in drug or placebo groups. The researcher will receive the drug product or placebo with a unique code for each patient. the researcher will receive the medicine or placebo in completely closed and invisible containers inside them and completely similar in appearance. Patients will be divided to four blocks of 28-patients blocks using a random number table in drug or placebo groups. N/A Fatigue in patients with Relapsing-remitting MS. Intervention 1: Intervention group: Receiving 2 L-carnitine tabletes (1000 mg tablets made by Karen pharma food and supplements) daily for a period of 2 months. Intervention 2: Control group:receiving placebo in the same shape and amount as L-carnitine tablets received by intervention group for a period of 2 months. The placebo will be produced by Pharmaceuticals Department of Tabriz university of medical science. Yes - There is a plan to make this available What will be shared: IPD will be available upon other researcher request via email to corresponding author, and following validation of the request. When: data will be available following study completion and without a time limit . To whom: to verified researchers following evaluation of their requests. Conditions: following receipt of a signed form, and agreement note from publisher. Where to obtain: data will be obtainable through publisher. How to obtain: the researcher should send a request to corresponding author and publisher. Comments:
public Sana Savadi Osgouei
No 63, Nastaran Alley, Shahriar street, Valiasr Kouy
Tabriz Iran (Islamic Republic of) 5157673638 +98 41 3327 6010 sanasavadi99@gmail.com Tabriz University of Medical Sciences scientific Mohammad Solduzian
Tabriz University of Medical Sciences,Attar Neyshabouri North, Golgasht street, Tabriz
Tabriz Iran (Islamic Republic of) 5166414766 +98 912 092 0355 dr.mohammadsolduzian@gmail.com Tabriz University of Medical Sciences Iran (Islamic Republic of) Patients with RRMS FSS>4 or MFIS>38 EDSS≤3.5 18 years 60 years Both EDSS≥4 Depression Hypothyroidism Patients receiving medicines like Antipsychotics, MAOi, Benzodiazepines, TCAs, Anti-seizures and Barbiturates Severe kidney disfunction with GFR<30 ml/min G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Receiving 2 L-carnitine tabletes (1000 mg tablets made by Karen pharma food and supplements) daily for a period of 2 months. Control group:receiving placebo in the same shape and amount as L-carnitine tablets received by intervention group for a period of 2 months. The placebo will be produced by Pharmaceuticals Department of Tabriz university of medical science. Fatigue. Timepoint: fatigue will be evaluated based on MFIS and FSS score before intervention and 2 months after. Method of measurement: Fatigue severity scale (FSS) and Modified fatigue impact scale (MFIS) Questionnaires. Tabriz University of Medical Sciences Approved 2021-11-29 Ethics committee of Tabriz University of Medical Science International Relations Office, No 2 Central Building, Tabriz University of Medical Sciences, University Street, Tabriz Tabriz East Azarbaijan Iran (Islamic Republic of)