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

تعیین تأثیر مکمل‌یاری با روغن سیاه‌دانه بر شاخص‌های التهابی، استرس اکسیداتیو، شدت بیماری، عملکرد شناختی و حرکتی، خستگی، کیفیت زندگی، استرس، فشار خون، قند خون ناشتا و پروفایل لیپیدی در بیماران مبتلا به مالتیپل اسکلروزیس.

Randomized, double-blind, placebo-controlled trial, two parallel groups, in 60 patients. Stratified block randomization with sealed envelopes.

The study is conducted at the Multiple Sclerosis Association in Ahvaz. 60 patients are randomly divided into two groups. Blood samples are collected before and after the intervention. Participants, investigators, and the outcome assessor are blinded.

Patients with Relapsing-Remitting Multiple Sclerosis, age 18 to 65 years, diagnosis confirmed by a neurologist, signing informed consent, no use of anti-inflammatory or antioxidant supplements in the past 3 months, no type 2 diabetes or severe cardiovascular disease, no pregnancy or lactation; exclusion: unwillingness to sign consent, progressive type, age out of range, use of mentioned supplements, diabetes or cardiovascular disease, pregnancy or lactation.

The intervention group receives 1000 milligrams of black seed oil daily and the control group receives placebo (sunflower oil) for 8 weeks. Both groups continue their standard treatment.

Inflammatory markers (CRP, ESR, IL-6, TNF-α, IL-17, TGF-β, Ferritin); oxidative stress markers (MDA, TBARS) and antioxidant markers (SOD, GPx, TAC); disease severity (EDSS); cognitive function (MoCA, SDMT); motor function (T25FW); fatigue severity (FSS); quality of life (MSIS-29); stress level (PSS); lipid profile (Chol, TG, LDL, HDL); fasting blood sugar (FBS); blood pressure.

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.

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.

Complete study protocol including objectives, design, inclusion and exclusion criteria, intervention methods, and outcomes

Access period starts 6 months after publication of the main results and continues for 5 years

Researchers affiliated with academic and scientific institutions

Only for non-commercial research purposes with citation of the source

Naghmeh Yazdi, Ahvaz Jundishapur University of Medical Sciences, Email: naghmeyazdi@yahoo.com

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