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IRCT20251126068121N1 IRCT 2025-12-08 Ahvaz University of Medical Sciences The effect of Allicin Supplementation on MS The effect of allicin supplementation on inflammation, oxidative stress and clinical symptoms in patients with multiple sclerosis 2025-12-25 anticipated 76 Complete https://irct.ir/trial/87881 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Other design features: This trial is the first to assess the effects of allicin supplementation on oxidative stress, inflammation, and clinical outcomes in patients with multiple sclerosis, Randomization description: Block‍‌‍‍‌ randomization with variable block sizes of 4 and 6 in a 1:1 allocation ratio will be used for randomization. An independent researcher will generate the random sequence by the Sealed Envelope online system (https://www.sealedenvelope.com/simple-randomiser/v1/lists), and allocation will be hidden by using the consecutively numbered, non-transparent, sealed envelopes each of which will have a unique alphanumeric code corresponding to the intervention container labeled. A team member, who is not involved in recruitment or assessment, will assign participants to the allicin or placebo ‍‌‍‍‌group, Blinding description: This study is double-blind. Participants and outcome assessment (including neurologist performing EDSS and T25FW evaluations) will remain blinded to group allocation. Care providers and laboratory personnel will also not be informed of treatment assignments to maintain blinding integrity. 3 Multiple sclerosis. Intervention 1: Intervention group: Participants will receive two 2 Dineh garlic tablets daily for 10 weeks (one after lunch and one after dinner). Each tablet contains 400 mg dried garlic powder standardized to 1.1 mg allicin, providing a total daily dose of 2.2 mg allicin. The supplement is manufactured by Dinehiran Company (Qazvin, Iran). Intervention 2: Control group: Participants will receive corn-starch–based placebo tablets identical in shape, size, color, taste, and packaging to the active supplement, manufactured by Dinehiran Company (Qazvin, Iran), taken on the same schedule. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information
public Ali Keshavarz
No. 48, Corner of Loqman St. and Soqrat St., opposite Iran Insurance, Amaniyeh District, Ahvaz, Khouzestan, Iran
Ahvaz Iran (Islamic Republic of) 6133994446 +98 61 3333 0747 keshavarz.a@ajums.ac.ir Ahvaz University of Medical Sciences scientific Seyed Ahmad Hosseini
Department of Nutrition, Paramedical School, Ahvaz Jundishapur University of Medical Sciences, Golestan Avenue, Ahvaz, Iran
Ahvaz Iran (Islamic Republic of) 0098 61 3333 3050 +98 61 3333 3050 seyedahmadhosseini@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Adults aged 18–55 years Confirmed diagnosis of RRMS (2017 McDonald criteria) EDSS score ≤ 5.5 Ability and willingness to provide informed consent Ability to adhere to daily supplementation 18 years 55 years Both Known allergy to garlic History of severe gastrointestinal disorders Uncontrolled psychiatric disorders Active malignancy Presence of other autoimmune diseases Use of medications affecting coagulation or platelet function change in MS medications or corticosteroid use within the past 3 months Active infection or systemic illness at the time of enrollment Pregnancy or breastfeeding Inability or unwillingness to cooperate with study procedures G35 Multiple sclerosis Treatment - Drugs Placebo Intervention group: Participants will receive two 2 Dineh garlic tablets daily for 10 weeks (one after lunch and one after dinner). Each tablet contains 400 mg dried garlic powder standardized to 1.1 mg allicin, providing a total daily dose of 2.2 mg allicin. The supplement is manufactured by Dinehiran Company (Qazvin, Iran). Control group: Participants will receive corn-starch–based placebo tablets identical in shape, size, color, taste, and packaging to the active supplement, manufactured by Dinehiran Company (Qazvin, Iran), taken on the same schedule. Total Antioxidant Capacity (TAC). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Laboratory kit. Interleukin 6 (IL-6). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Laboratory kit. C-reactive protein (CRP). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: immunoturbidimetric assay using an automated analyzer. Erythrocyte Sedimentation Rate (ESR). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Westergren method. Malondialdehyde (MDA). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Laboratory kit. Glutathione Peroxidase (GPx). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Laboratory kit. Superoxide Dismutase (SOD). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Laboratory kit. Timed 25-Foot Walk (T25-FW). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Assessed by a neurologist. Expanded Disability Status Scale (EDSS). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Assessed by a neurologist (McDonald criteria). Fasting Blood Sugar. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Enzymatic. Lipids profile (Total-C, TG, HDL-C, LDL-C). Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Enzymatic colorimetric methods for TC, TG, and HDL-C. LDL-C will be calculated using the Friedewald's formula: LDL-C = TC − HDL-C − (TG/5). Blood pressure. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: BEURER-BM44 digital blood pressure monitor. Pain intensity. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Visual Analog Scale (VAS). Fatigue severity. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Questionnaire of Fatigue Severity Scale (FSS). Sleep quality. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: PSQI questionnaire. General mental health. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: General health questionnaire - 28 (GHQ-28). Quality of life score. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: SF-36 questionnaire. Weight. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Using scales. Body mass index. Timepoint: At the beginning of the study and 10 weeks after the intervention. Method of measurement: Weight in kilograms divided by height in meters squared.kg/m2. Dietary intake. Timepoint: At the beginning of the study, at week 5, and 10 weeks after the intervention. Method of measurement: using Nutritionist IV software. Ahvaz University of Medical Sciences Approved 2025-11-08 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ethics Committee, Ahvaz Jundishapur University of Medical Sciences, Golestan Avenue, Ahvaz, Iran Ahvaz Khouzestan Iran (Islamic Republic of)