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IRCT20151028024760N5 IRCT 2022-11-09 Mashhad University of Medical Sciences Evaluation of the effects of supplementation extract prepared from Capparis spinosa on clinical manifestations in patients with refractory rheumatoid arthritis. Evaluation of the effects of supplementation extract prepared from Capparis spinosa on clinical manifestations, para-clinical and immunological factors in patients with refractory rheumatoid arthritis. 2023-06-22 anticipated 30 Complete https://irct.ir/trial/66571 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: Thirty patients with rheumatoid arthritis who are refractory to standard therapies will be enrolled in this study. The patients will be randomized into three groups (10 patients in each group), group A (Capparis spinosa), group B (Placebo) and group C (Conventional therapy) based on a table of random numbers. Randomization will be performed by block randomization, using online random number generator (Sealed Envelope) https://www.sealedenvelope.com/simple-randomiser/v1/lists. An independent researcher will perform randomization in blocks using an online random number generator. The pharmacist will fill pill containers with each medication (Capparis spinosa or placebo) and will place them into sequentially numbered sealed envelopes in the order determined by randomization. The tools and materials needed to make the placebo will be exactly the same as the medicine except that only the active ingredient is removed from the placebo, Blinding description: In this study the patients will be unaware of the group which they have been allocated in. Drugs have no label thus patients will not be aware of the type of treatment they receive. In addition, the outcome assessor and data analyser will not be aware of the type of intervention. 2-3 Rheumatoid arthritis. Intervention 1: Intervention group: Refractory rheumatoid arthritis (RA) patients will be treated by extract prepared from Capparis spinosa (600 mg daily for three months) that will be produced at Pharmacological research center of medicinal plants, school of Medicine, Mashhad university of medical sciences, mashhad, Iran. Intervention 2: Control group: Refractory RA patients will be treated by placebo. Intervention 3: Control group: Refractory RA patients will be treated by conventional therapy. Undecided - It is not yet known if there will be a plan to make this available Justification or reason for indecision in sharing IPD is There is no further information.
public DR. Mojgan Mohammadi
BuAli Research Institute, BuAli Square, Ferdowsi Sq
Mashhad Iran (Islamic Republic of) 9196773117 +98 51 3711 2611 Mohammadimzh@mums.ac.ir Mashhad University of Medical Sciences scientific Dr. Mojgan Mohammadi
BuAli Research Institute, BuAli Square, Ferdowsi Sq
Mashhad Iran (Islamic Republic of) 9196773117 +98 51 3711 2611 Mohammadimzh@mums.ac.ir Mashhad University of Medical Sciences Iran (Islamic Republic of) Resistant rheumatoid arthritis (RA) patients to non-biological disease-modifying anti-rheumatic drugs (DMARDs) Treated RA patients by non-biological drugs Treated RA patients by Prednisolone, Hydroxychloroquine, Sulfasalazine and Methotrexate Refractory RA patients with no other Rheumatic disorders and inflammatory diseases 35 years 60 years Both Non-resistant RA patients to non-biological disease-modifying anti-rheumatic drugs (DMARDs) M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Placebo N/A Intervention group: Refractory rheumatoid arthritis (RA) patients will be treated by extract prepared from Capparis spinosa (600 mg daily for three months) that will be produced at Pharmacological research center of medicinal plants, school of Medicine, Mashhad university of medical sciences, mashhad, Iran. Control group: Refractory RA patients will be treated by placebo. Control group: Refractory RA patients will be treated by conventional therapy. Disease activity score 28-joint count-erythrocyte sedimentation rate (DAS28-ESR). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Clinical and laboratory findings. Visual analog scale (VAS) to assess the level of joint pain. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The amount of pain that a patient feels. Rheumatoid factor (RF). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Latex agglutination test. C-reactive protein (CRP). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Latex agglutination test. Anti-cyclic citrullinated peptide (anti-CCP). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Enzyme-linked immunosorbent assay (ELISA) test. Erythrocyte sedimentation rate (ESR). Timepoint: Before intervention and after 3 months follow up. Method of measurement: Erythrocyte sedimentation rate in millimeters. Regulatory T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. Th17 cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. CD4+ T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. CD8+ T cells. Timepoint: Before intervention and after 3 months follow up. Method of measurement: Frequency of desired cells using flow cytometry technique. FOXP3 transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR). T-bet transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR). ROR-gamma T transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR). GATA3 transcription factor. Timepoint: Before intervention and after 3 months follow up. Method of measurement: The copy number of desired gene using reverse transcription polymerase chain reaction (RT-PCR). Interferon gamma. Timepoint: Before intervention and after 3 months follow up. Method of measurement: pg/ml using enzyme-linked immunosorbent assay (ELISA). Transforming Growth Factor-β. Timepoint: Before intervention and after 3 months follow up. Method of measurement: pg/ml using enzyme-linked immunosorbent assay (ELISA). Tumor necrosis factor-α. Timepoint: Before intervention and after 3 months follow up. Method of measurement: pg/ml using enzyme-linked immunosorbent assay (ELISA). Interleukin-4. Timepoint: Before intervention and after 3 months follow up. Method of measurement: pg/ml using enzyme-linked immunosorbent assay (ELISA). Interleukin-10. Timepoint: Before intervention and after 3 months follow up. Method of measurement: pg/ml using enzyme-linked immunosorbent assay (ELISA). Interleukin-17A. Timepoint: Before intervention and after 3 months follow up. Method of measurement: pg/ml using enzyme-linked immunosorbent assay (ELISA). Mashhad University of Medical Sciences Approved 2022-04-26 Ethics committee of Mashhad University of Medical Sciences Qoreishi Bulding, Daneshgah St Mashhad Razavi Khorasan Iran (Islamic Republic of)