Rheumatoid arthritis. Seropositive rheumatoid arthritis
Conditions
Interventions
Intervention 1: Intervention group:medicinal product BTMC-1 (capsule prepared from hydroalcoholic extract of Matricaria chamomile), each capsule contains 800 mg of hydroalcoholic extract of Matricaria
Sponsors
Immunoregulation Research Center
Eligibility
Sex/Gender
Female
Age
20 Years to 65 Years
Inclusion criteria
Inclusion criteria: Informed consent of the patient to participate in the study and sampling Confirmation the criteria of rheumatoid arthritis disease by the attending physician and laboratory findings patients who have active rheumatoid arthritis (2.6<DAS28<5.1) Patients should have fixed treatment 3 weeks before the intervention and during the intervention The duration of the disease in patients should be less than 5 years Consume the methotrexate as the main treatment
Exclusion criteria
Exclusion criteria: Lack of consent to continue participating in the study Having another disease that requires active medical care Consumption of any vitamins, minerals and food supplements 3 months before the intervention and during the intervention (except vitamin D which is consumed by all patients) Patients who have DAS28 higher than 5.1 Pregnancy and lactation Patients who are relatives in order to avoid statistical bias Irregular consumption of intervention Excessive consumption of fruit and natural fruit juices during the intervention
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The amount of pro-inflammatory cytokines( interleukin 6,1,TNF-alpha). Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: Sandwich ELISA (ELISA Kit, R&D System Company).;The amount of rheumatoid factor autoantibody. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: Turbidometry with Hitachi 912 device.;The amount of Anti-cyclic citrullinated peptide (anti-CCP) antibody. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: ELISA (ELISA Kit, R&D System Company).;Erythrocyte sedimentation rate. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: Westergren-Katz tube.;C-reactive protein. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: Hitachi autoanalyzer.;White blood cells count. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: hematologic autoanalyzer(sysmex). | — |
Secondary
| Measure | Time frame |
|---|---|
| The amount of pain. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: Visual Analogue Scale.;Severity of the disease. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: disease activity questionnaire 28 (DAS28).;The duration of morning joints stiffness. Timepoint: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. Method of measurement: Patient self-report in minutes.;Evaluation of the disability. Timepoint: health assessment questionnaire - disability index(HAQ-DI). Method of measurement: At the beginning of the study and 45 days after the intervention (pharmaceutical product BTMC-1) consumption. | — |
Countries
Iran (Islamic Republic of)
Contacts
Public ContactMahdiyeh Nateghi
Shahed University
Outcome results
None listed