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IRCT20181113041641N2 IRCT 2022-10-08 Artesh University of Medical Sciences Complementary Medicine in Multiple Sclerosis Effects of Dietary Modification Based on Complementary and Alternative Iranian Medicine in Patients with Secondary-Progressive Multiple Sclerosis 2022-08-22 anticipated 70 Complete https://irct.ir/trial/62769 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Stratified block randomization will be conducted for this trial. In the stratified block randomization method, an independent chain of random numbers (with block method) will be prepared for each stratum to assign participants of that stratum into two study groups (1. complementary/alternative diet group and 2. control group). Therefore, for each MS treatment plan determined by the neurologist (three common types of MS drugs; monoclonal antibodies, sphingosine-1-phosphate receptor modulators, and dimethyl fumarate), the random sequence will be prepared in a 1:1 ratio with letters A and B (for intervention and control groups, respectively). Random sequences will be extracted from the site (https://www.sealedenvelope.com/). The neurologist will determine the treatment plan of the participants, and therefore, the study group (A or B) will be determined based on the related random chain. Once the randomization has been made, each patient is given a code with which they will be identified throughout the study, Blinding description: In this trial, blinding of participants and dieticians is not possible because of obvious differences between the intervention and control diet; however, each patient is given a code, and an employee outside of the research team will enter data into the computer in separate datasheets. Therefore, outcome assessors and data analysts will be blinded to treatment allocation. 3 Multiple Sclerosis. Intervention 1: Intervention group. The intervention diet will be designed based on complementary and alternative Iranian medicine. The present diet will recommend the intake of foods with moderate-nature for eight weeks (two months). Fresh vegetables and fruits, nuts, legumes, whole grains, and olive oil are the main constituents. This diet contains 45-50% of energy from carbohydrates, 35% from fats, and 15-20% from proteins. The required energy of each subject will be determined based on ideal body weight. Two education sessions will be conducted for participants, and the adherence to diet will be evaluated during two follow-up sessions. Intervention 2: Control group will receive their current diet plus healthy dietary recommendations and energy adjustment for eight weeks (two months). Yes - There is a plan to make this available What will be shared: The major part of the results will be available to individuals. Moreover, the datasets used and/or analyzed during the current study are available from the investigators, on reasonable request. When: The data will become available 8 months after the results' publication. To whom: The data/document is available for all individuals, on reasonable request. Conditions: The data/document must be used for conducting similar studies and therapeutic approaches, on reasonable request from the investigators. Where to obtain: mail to amimohs@gmail.com or a.moravej@mail.mui.ac.ir How to obtain: The data will be sent as soon as possible, after receiving the request. Comments:
public Vahid Hadi
AJA university of Medical Sciences, Shahid Etemadzadeh St., West fatemi St.,
Tehran Iran (Islamic Republic of) 1411718541 +98 21 8609 6350 vahidhadi1@gmail.com Artesh University of Medical Sciences scientific Sayid Mahdi Mirghazanfari
AJA university of Medical Sciences, Shahid Etemadzadeh St., West fatemi St.
Tehran Iran (Islamic Republic of) 1411718541 +98 912 276 5221 smmirghazanfari@gmail.com Artesh University of Medical Sciences Iran (Islamic Republic of) Iran (Islamic Republic of) Secondary-Progressive MS patients (diagnosed by a neurologist according to expanded disability status scale) Aged between 18-60 years old. Receiving vitamin D3 50000 IU orally per week Consent to participate in the study 18 years 60 years Both Concurrent participation in other clinical trials COVID-19 infection Type 2 diabetes Regular intake of anti-anxiety and anti-depressant drugs The occurrence of MS attack Smoking (at least two cigarettes per day) Adherence to special diets or nutritional supplements G35 Multiple sclerosis Treatment - Other Placebo Intervention group. The intervention diet will be designed based on complementary and alternative Iranian medicine. The present diet will recommend the intake of foods with moderate-nature for eight weeks (two months). Fresh vegetables and fruits, nuts, legumes, whole grains, and olive oil are the main constituents. This diet contains 45-50% of energy from carbohydrates, 35% from fats, and 15-20% from proteins. The required energy of each subject will be determined based on ideal body weight. Two education sessions will be conducted for participants, and the adherence to diet will be evaluated during two follow-up sessions. Control group will receive their current diet plus healthy dietary recommendations and energy adjustment for eight weeks (two months). Serum level of high sensitivity C-Reactive Protein (hs-CRP). Timepoint: At baseline and 8 weeks later. Method of measurement: Chemi Luminescent ImmunoAssays (CLIAs). Serum Estimated Sedimentation Rate (ESR). Timepoint: At baseline and 8 weeks later. Method of measurement: Westergren method. Quality of life. Timepoint: At baseline and 8 weeks later. Method of measurement: Multiple Sclerosis Quality of Life (MSQOL-54) 54 items. Disease activity. Timepoint: At baseline and 8 weeks later. Method of measurement: scoring form of Expanded Disability Status Scale (EDSS). Dietary intakes of vitamins, minerals, and antioxidants. Timepoint: At baseline and 8 weeks later. Method of measurement: N4 software. Fatigue severity. Timepoint: At baseline and 8 weeks later. Method of measurement: Modified Fatigue Impact Scale 21 items (MFIS) questionnaire. Pain severity. Timepoint: At baseline and 8 weeks later. Method of measurement: Global Pain Scale (GPS). Anxiety severity. Timepoint: At baseline and 8 weeks later. Method of measurement: State-Trait Anxiety Inventory (STAI 1 and 2) 20 items. Gastrointestinal evaluation. Timepoint: At baseline and 8 weeks later. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) 15 items. Body weight. Timepoint: At baseline and 8 weeks later. Method of measurement: SECA digital scale. Body mass index. Timepoint: At baseline and 8 weeks later. Method of measurement: weight (in kilograms) divided by the square of height (in metres). Percent of body fat. Timepoint: At baseline and 8 weeks later. Method of measurement: Deurenberg equation. Triceps Skinfold thickness. Timepoint: At baseline and 8 weeks later. Method of measurement: Skinfold Caliper. Artesh University of Medical Sciences Approved 2022-08-21 Ethics committee of AJA University of Medical Sciences AJA university of Medical Sciences, Shahid Etemadzadeh St., West fatemi St., Tehran Tehran Iran (Islamic Republic of)