Rheumatoid arthritis. Rheumatoid arthritis, unspecified
Conditions
Interventions
Intervention 1: The control group will receive two soft gel capsules containing 500 milligram paraffin as placebo every day for eight consecutive weeks. The placebo preparation process will be conduct
Placebo
Treatment - Drugs
The control group will receive two soft gel capsules containing 500 milligram paraffin as placebo every day for eight consecutive weeks. The placebo preparation process will be conducted in Barij Esse
The case group will receive two soft gel capsules containing 500 milligram of nigella sativa oil extract every day for eight consecutive weeks. The extraction will be conducted by cold press method. B
Sponsors
Vice chancellor for Research, Tabriz University of Medical Sciences
Eligibility
Sex/Gender
Female
Age
20 Years to 50 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1) Subjects diagnosed with rheumatoid arthritis, based on American College of Rheumatology/European League Against Rheumatism (ACR-EULAR) criteria; 2) Patients with mild to moderate rheumatoid arthritis; 3) Under treatment with disease-modifying antirheumatic drugs (Methotrexate, Hydroxychloroquine and Prednisolone less than 10 milligrams per day) and not receiving non-steroidal anti-inflammatory drugs or cytokine inhibitors; 4) Stable medication for at least 2 months prior to the interventions; 5) Have a body mass index (BMI) less than 40; 6) Willing to participate in the study; 7) Ages between 20 and 50. Exclusion criteria: 1) Pregnant and lactating women; 2) Hormone therapy or receiving oral contraceptives; 3) Have diabetes mellitus, thyroid disorders, kidney or hepatic diseases or Cushing's syndrome; 4) Have inflammatory bowel disease or other inflammatory disorders; 5) Taking antioxidant and anti- inflammatory supplements 4 weeks prior to the interventions; 7) Being on a weight reduction diet; 7) Smoking or being exposed to cigarette smoke.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Catalase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Superoxide dismutase. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;CD4+. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: flow cytometry.;CD25+. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: flow cytometry.;CD8+. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: flow cytometry.;Tumor necrosis factor-alpha (TNF-a). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;Interleukin 10 (IL-10). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: ELISA.;Nitric oxide. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Malondialdehyde. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Spectrophotometry.;Rheumatoid factor. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Autoanalyzer system.;High-sensitivity C-reactive protein (hs-CRP). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Immunoturbidimetry.;Disease Activity Score (DAS-28). Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: calculation based on physical examination and serum hs-CRP. | — |
Secondary
| Measure | Time frame |
|---|---|
| Diastolic blood pressure. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Stethoscope and sphygmomanometer.;Systolic blood pressure. Timepoint: At baseline and after 8 weeks of intervention. Method of measurement: Stethoscope and sphygmomanometer. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactDr. Sorayya Kheirouri
Tabriz University of Medical Sciences
Outcome results
None listed