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IRCT20201001048897N1 IRCT 2021-01-02 Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran. Therapeutic Efficacy of Urtica dioica and Evening Primrose in Patients with Rheumatoid Arthritis Therapeutic Efficacy of Urtica dioica and Evening Primrose in Patients with Rheumatoid Arthritis: A Randomized Double-Blind, Placebo-Controlled Clinical Trial 2021-01-09 anticipated 90 Complete https://irct.ir/trial/51358 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: - Simple randomization, shuffling cards - Unit of Randomization: individual - Tools used in randomization: cards shuffling - How to make a random sequence: In this method, a number of cards selected by the researcher as the first group and the same number of cards for the next groups are considered; Then, by merging the cards together (cards shuffling), a card is removed and its allocation is recorded, and that card is returned to all other cards after the new card is removed. The cards are then shuffled and another card is issued. This process is followed by reaching a random sequence according to the sample size continues. - Concealment: Herbal medicines and placebo are provided to patients with exactly the same packaging, Blinding description: The results evaluator and patients did not know how to intervene.code was defined for the study groups. 2 Therapeutic Efficacy of Urtica dioica and Evening Primrose in Patients with Rheumatoid Arthritis: A Randomized Double-Blind, Placebo-Controlled Clinical Trial. Intervention group 1: Magnolia evening primrose 400 mg capsule Intervention group 2: Nettle capsule Nettle capsule 400 mg Control group: placebo 500 mg capsule for three months three times a day Barij Essential Oil Company. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information
public Bahareh Abd-Nikfarjam
Bahonar Blv.
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 info@qums.ac.ir Qazvin University of Medical Sciences scientific Bahareh Abd-Nikfarjam
Bahonar Blv.
Qazvin Iran (Islamic Republic of) 34199-15315 +98 28 3333 6001 bnikfarjam@qums.ac.ir Qazvin University of Medical Sciences Iran (Islamic Republic of) RA was diagnosed according to the revised 2010 American College of Rheumatology (ACR) criteria no limit no limit Both Patients with cardiovascular disease Patients with respiratory diseases Patients with renal disease Patients with liver disease Patients under sex hormone therapy Use supplements before the intervention Changing the treatment of RA patients Allergy to nettle Patients with other inflammatory diseases Other Intervention group 1: Magnolia evening primrose 400 mg capsule Intervention group 2: Nettle capsule Nettle capsule 400 mg Control group: placebo 500 mg capsule for three months three times a day Barij Essential Oil Company DAS28 (Disease Activity Score) The DAS28 is a measure of disease activity in rheumatoid arthritis (RA). DAS stands for 'disease activity score', and the number 28 refers to the 28 joints that are examined in this assessment. Timepoint: Disease Activity Score 28 is measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: The Disease Activity Score 28 is most easily calculated using a programmed calculator or a computer. Online and downloadable calculators are freely available at http://www.das-score.nl. DAS28 (Disease Activity Score) The DAS28 is a measure of disease activity in rheumatoid arthritis (RA). DAS stands for 'disease activity score', and the number 28 refers to the 28 joints that are examined in this assessment. Timepoint: Disease Activity Score 28 is measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: The Disease Activity Score 28 is most easily calculated using a programmed calculator or a computer. Online and downloadable calculators are freely available at http://www.das-score.nl. Visual Analogue Scale (VAS) The visual analog scale is a validated, subjective measure for acute and chronic pain. Timepoint: Visual Analogue Scale is measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: Visual Analogue Scale scores are recorded by making a handwritten mark on a 10-cm line that represents a continuum between “no pain” and “worst pain.”. IL-17 cytokine has an important role in protective immunity. IL-17 plays a critical role in the parthenogenesis of various autoimmune inflammatory diseases such as rheumatoid arthritis. Timepoint: IL-17 cytokine measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: Inflammatory cytokine IL-17 is measured by enzyme-linked immunosorbent assay (ELISA) technique. Total Antioxidant Capacity (TAC) Assay measures the total antioxidant capacity of biomolecules from a variety of samples like a human serum. Timepoint: Total antioxidant capacity measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: Total antioxidant capacity is measured by enzyme-linked immunosorbent assay (ELISA) technique. Anti-cyclic citrullinated autoantibodies are produced by the immune system that is directed against cyclic citrullinated peptides (CCP). This test detects and measures anti-CCP antibodies in the blood. Citrulline is naturally produced in the body as part of the metabolism of the amino acid arginine. Timepoint: Anti-cyclic citrirullinated peptide measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: Anti-cyclic citrirullinated peptide is measured by enzyme-linked immunosorbent assay (ELISA) technique. C Reactive protein (CRP) is an acute-phase protein of hepatic origin that increases following interleukin-6 secretion by macrophages and T cells. Timepoint: Reactive protein C measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: The CRP latex agglutination assay is a qualitative and semi-quantitative test. The latex particles used in the CRP latex agglutination test are coated with anti-human CRP that agglutinate upon mixing with patient serum containing CRP. Rheumatoid factor (RF) is the autoantibody that was first found in rheumatoid arthritis. It is defined as an antibody against the Fc portion of IgG and different RFs can recognize different parts of the IgG-Fc. RF and IgG join to form immune complexes that contribute to the disease process. Timepoint: Rheumatoid Factor measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: Agglutination tests: One test method mixes blood with latex beads that are covered with human antibodies. If RF is present, the latex beads clump together (agglutinate). This method is best used as a first-time screening test for rheumatoid arthritis. Erythrocyte sedimentation rate (ESR) is a test that indirectly measures the degree of inflammation present in the body. The test actually measures the rate of fall (sedimentation) of erythrocytes in a sample of blood that has been placed into a tall, thin, vertical tube. Timepoint: Erythrocyte sedimentation rate measured at the beginning of the study (before the start of the intervention) and at the end of the study (3 months after the start of herbal medicine, nettle or evening primrose, and placebo). Method of measurement: Western Green is a method for estimating the sedimentation rate of red blood cells in whole blood by mixing venous blood with an aqueous solution of sodium citrate and allowing the mixture to stand in an upright standard pipet and, after one hour, reading the millimeters the cells have descended. Metabolic Diseases Research Center, Qazvin University of Medical Sciences, Qazvin, Iran. Approved 2017-03-19 Ethics Subcommittee on Biomedical Research Bahonar Blvd. Qazvin Qazvin Iran (Islamic Republic of)