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IRCT20260918071095N1 IRCT 2026-09-24 Deputy of Research and Technology, Ahvaz Jundishapur University of Medical Sciences Effect of Black Seed Oil on Inflammation, Neurological Function, and Quality of Life in Patients with Multiple Sclerosis Investigating the effect of black seed oil supplementation on inflammatory biomarkers, neurological function, and quality of life in Patients with Multiple Sclerosis: A Randomized, Double-Blind, Placebo-Controlled Clinical Trial 2026-06-28 anticipated 60 Complete https://irct.ir/trial/93476 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: This study uses stratified randomization. First, participants are divided into homogeneous groups (strata) based on influential variables including age, gender, and disease severity according to the EDSS scale. Then, within each stratum, a random sequence for allocating individuals to the intervention and control groups is generated using block randomization with blocks of four. The unit of randomization is individual. Randomization tools include statistical software and sealed envelopes. For allocation concealment, the sealed envelope method is used. Accordingly, the random sequence is placed inside opaque, sealed envelopes, and each envelope is opened only at the moment of allocation of the individual to the respective group. This method ensures that investigators and participants remain unaware of the group assignment until the time of allocation, Blinding description: This study is designed as a randomized, double-blind clinical trial. In this study, participants and investigators will be unaware of the assigned group (intervention or control). To achieve this, a concealed allocation method using sealed, block-randomized, and coded envelopes will be used. The packages containing black seed oil supplement and placebo are completely identical in shape, color, odor, and weight and are coded by the manufacturer so that neither participants nor investigators can identify their contents. The outcome assessor is also unaware of the participants' group allocation, and assessments are performed by a blinded, fixed assessor. Data analysis will also be performed after the study completion while maintaining group blinding. In case of severe adverse events, if necessary, the code for the respective group will be unblinded. N/A Multiple Sclerosis+. Intervention 1: Intervention group: Daily consumption of one 1000 milligram capsule of black seed oil (manufactured by Barij Essence Company) for 8 weeks. Intervention 2: Control group: Daily consumption of one 1000 milligram placebo capsule (sunflower oil) that is completely identical in shape, color, odor, and weight to the black seed oil capsule, for 8 weeks. Yes - There is a plan to make this available What will be shared: Complete study protocol including objectives, design, inclusion and exclusion criteria, intervention methods, and outcomes When: Access period starts 6 months after publication of the main results and continues for 5 years To whom: Researchers affiliated with academic and scientific institutions Conditions: Only for non-commercial research purposes with citation of the source Where to obtain: Naghmeh Yazdi, Ahvaz Jundishapur University of Medical Sciences, Email: naghmeyazdi@yahoo.com How to obtain: Submission of a written request to the principal investigator's email, review of the request by the research team, approval and sending of documents within a maximum of 2 weeks Comments:
public Naghmeh Yazdi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Khuzestan, Iran
ahvaz Iran (Islamic Republic of) ۶۱۳۵۷۱۵۷۹۴ +98 916 311 9228 naghmeyazdi@yahoo.com Ahvaz University of Medical Sciences scientific Naghmeh Yazdi
Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Khuzestan, Iran
ahvaz Iran (Islamic Republic of) ۶۱۳۵۷۱۵۷۹۴ +98 916 311 9228 naghmeyazdi@yahoo.com Ahvaz University of Medical Sciences Iran (Islamic Republic of) Signing the informed consent form Definitive diagnosis of Relapsing-Remitting Multiple Sclerosis based on McDonald criteria Confirmation of diagnosis by a neurologist Age between 18 and 65 years No use of other anti-inflammatory or antioxidant supplements in the past 3 months Acceptance of regular consumption of black seed oil supplement during the study No chronic comorbid diseases such as type 2 diabetes and severe cardiovascular diseases No pregnancy or lactation in female participants No history of severe or chronic gastrointestinal problems 18 years 65 years Both Unwillingness to sign the informed consent form Diagnosis of Primary Progressive or Secondary Progressive Multiple Sclerosis Lack of confirmation of diagnosis by a neurologist Age younger than 18 years or older than 65 years Use of other anti-inflammatory or antioxidant supplements in the past 3 months Non-acceptance of regular consumption of black seed oil supplement during the study Presence of chronic comorbid diseases such as type 2 diabetes Presence of severe cardiovascular diseases Pregnancy or lactation in women History of severe or chronic gastrointestinal problems Presence of acute infection or systemic diseases during the study period Use of new drugs that may affect inflammatory and oxidative stress markers Unwillingness to continue cooperation and voluntary withdrawal Multiple s G35 Treatment - Drugs Placebo Intervention group: Daily consumption of one 1000 milligram capsule of black seed oil (manufactured by Barij Essence Company) for 8 weeks Control group: Daily consumption of one 1000 milligram placebo capsule (sunflower oil) that is completely identical in shape, color, odor, and weight to the black seed oil capsule, for 8 weeks Glutathione Peroxidase Enzyme Activity in Blood Serum. Timepoint: Measurement of Glutathione Peroxidase Enzyme Activity at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Glutathione Peroxidase Enzyme Activity in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Superoxide Dismutase Enzyme Activity in Blood Serum. Timepoint: Measurement of Superoxide Dismutase Enzyme Activity at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Superoxide Dismutase Enzyme Activity in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Malondialdehyde Level in Blood Serum. Timepoint: Measurement of Malondialdehyde Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Malondialdehyde Level in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Total Antioxidant Capacity in Blood Serum. Timepoint: Measurement of Total Antioxidant Capacity at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Total Antioxidant Capacity in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. C-Reactive Protein Level in Blood Serum. Timepoint: Measurement of C-Reactive Protein Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of C-Reactive Protein Level in Blood Serum Using Autoanalyzer. Erythrocyte Sedimentation Rate. Timepoint: Measurement of Erythrocyte Sedimentation Rate at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Erythrocyte Sedimentation Rate Using Specific Tube and Westergren Technique. Interleukin 6 Level in Blood Serum. Timepoint: Measurement of Interleukin 6 Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Interleukin 6 Level in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Tumor Necrosis Factor Alpha Level in Blood Serum. Timepoint: Measurement of Tumor Necrosis Factor Alpha Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Tumor Necrosis Factor Alpha Level in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Interleukin 17 Level in Blood Serum. Timepoint: Measurement of Interleukin 17 Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Interleukin 17 Level in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Transforming Growth Factor Beta Level in Blood Serum. Timepoint: Measurement of Transforming Growth Factor Beta Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Transforming Growth Factor Beta Level in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Ferritin Level in Blood Serum. Timepoint: Measurement of Ferritin Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Ferritin Level in Blood Serum Using Karmania Pars Gene Company Kit and Enzyme-Linked Immunosorbent Assay Method. Multiple Sclerosis Disease Severity Based on Expanded Disability Status Scale. Timepoint: Measurement of Disease Severity at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Disease Severity Using Expanded Disability Status Scale by a Neurologist. Cognitive Function Based on Montreal Cognitive Assessment. Timepoint: Measurement of Cognitive Function at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Cognitive Function Using Montreal Cognitive Assessment by a Neurologist. Cognitive Function Based on Symbol Digit Modalities Test. Timepoint: Measurement of Cognitive Function at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Cognitive Function Using Symbol Digit Modalities Test by a Neurologist. Motor Function Based on Timed 25-Foot Walk Test. Timepoint: Measurement of Motor Function at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Motor Function Using Timed 25-Foot Walk Test. Fatigue Severity Based on Fatigue Severity Scale. Timepoint: Measurement of Fatigue Severity at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Fatigue Severity Using Fatigue Severity Scale. Quality of Life Based on Multiple Sclerosis Impact Scale. Timepoint: Measurement of Quality of Life at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Quality of Life Using Multiple Sclerosis Impact Scale. Perceived Stress Level Based on Perceived Stress Scale. Timepoint: Measurement of Perceived Stress Level at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Assessment of Perceived Stress Level Using Perceived Stress Scale. پروفایل لیپیدی شامل کلسترول تام، تری‌گلیسرید، لیپوپروتئین با چگالی کم و لیپوپروتئین با چگالی بالا در سرم خون. Timepoint: Measurement of Lipid Profile at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Lipid Profile in Blood Serum Using Autoanalyzer. قند خون ناشتا در سرم خون. Timepoint: Measurement of Fasting Blood Sugar at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Fasting Blood Sugar in Blood Serum Using Autoanalyzer. Systolic and Diastolic Blood Pressure. Timepoint: Measurement of Blood Pressure at Baseline (Before the Intervention) and 8 Weeks After the Start of Black Seed Oil Supplementation. Method of measurement: Measurement of Systolic and Diastolic Blood Pressure Using Standard Sphygmomanometer. Deputy of Research and Technology, Ahvaz Jundishapur University of Medical Sciences Approved 2026-06-27 Ethics Committee of Ahvaz Jundishapur University of Medical Sciences Ahvaz Jundishapur University of Medical Sciences, Golestan Blvd., Ahvaz, Khuzestan, Iran Ahvaz Khouzestan Iran (Islamic Republic of)