Investigation of the Effects of Sumac Supplementation on Disease Activity, Inflammatory Markers, and Immunomodulatory Factors in Patients with Rheumatoid Arthritis

Investigation of the Effects of Sumac Supplementation on Disease Activity, Inflammatory Markers, and Immunomodulatory Factors in Patients with Rheumatoid Arthritis

Clinical trial with control group, double-blind, randomized, on 96 patients.

Rheumatoid arthritis patients referred to zarrinkob clinic in Borujerd who are eligible for the study will have a blood test once at the beginning and once after the intervention and the factors will be measured.

Age between 20 and 60 years; diagnosis of rheumatoid arthritis (RA) according to the American College of Rheumatology (ACR) criteria (presence of at least 4 of the following criteria for a minimum of 6 weeks: 1) morning stiffness lasting at least 1 hour, 2) arthritis in three or more joint areas, 3) arthritis of hand joints, 4) symmetric arthritis, 5) rheumatoid nodules, 6) positive rheumatoid factor, and 7) typical radiographic changes in the wrists and hands); disease duration of at least 1 year; and no changes in medication regimen during the previous 2 months.Smoking; use of nutritional or antioxidant supplements within one month prior to the study; pregnancy or lactation; history of diabetes or other chronic diseases; history of other autoimmune diseases; changes in medication regimen during the past month; and adherence to special dietary regimens.

Two groups of 48 people with rheumatoid arthritis: 48 people in the group receiving 1000 mg of sumac capsules and 48 people in the group receiving placebo (lactose capsules)

hs-CRP, TNF-α, MMPs, ESR, TAC, IFN-γ, IL-17, calprotectin, zonulin, lipopolysaccharide, number of painful joints, number of inflamed joints, number of tender joints, pain; disease activity score (DAS28), joint stiffness

Participants will be randomly selected from patients referred to a rheumatologist at Zarrinkoub Clinic. After meeting the eligibility criteria, participants will be randomly allocated to either the intervention or control group using block randomization generated by STATA software. Randomization will be stratified by age (20–40 years and 40–60 years) and sex to ensure comparability between the two groups. A total of 96 eligible participants will be randomly assigned to 24 blocks of four subjects each. Random block sequences (Groups A and B) will be generated using STATA software or the Sealed Envelope randomization website and provided to the researcher.

Sumac or placebo will be coded by a third party who is unaware of the contents of the packages. None of the participants, nor the researcher or analyst, will be aware of the groups (sumac or placebo) and the type of intervention (sumac or placebo), and the packages containing the powder will be supplied by the company, as well as the placebo and sumac packages, in terms of internal and external appearance. After data analysis, the pharmaceutical company will be asked for the label title (drug or placebo) to compile the report and write the findings section.

Only a section of the data, such as primary outcomes information or the like, will be shared.

Access period start 5 months after results publishing.

The obtained data from current study will be available only for working researchers in academic and scientific institutions

5 months after the publicized papers from this study, the obtained data will be available to the researchers for further analysis.

Applicants can be communicated to correspond author be e-mail or postal address to receive the requested data. Postal address: Nutrition Department, School of Public Health, Iran University of Medical Sciences, Hemat Highway, Tehran Cell phone: +982186704743 Email: n-aryaeian@sina.tums.ac.ir

Publishing in scientific-research journals Applicants will be given access to the obtained data from current study by sending an email to correspond author.