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IRCT20230209057368N1 IRCT 2023-02-20 Immunoregulation Research Center Evaluate the health benefits of the BTMC-1 drug product in rheumatoid arthritis patients Evaluate the health benefits of the BTMC-1 drug product in rheumatoid arthritis patients: a double-blinded randomized clinical trial 2023-02-24 anticipated 40 Complete https://irct.ir/trial/68515 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Treatment, Randomization description: The randomization will be done based on the permutation of random blocks, in such a way that the drug and placebo are specified as, A and B, and the random numbers generated by the RAND function in Excel software are dedicated to the AB and BA blocks (binary block) and finally, based on random numbers, the list of drug and placebo will be assigned for patients, Blinding description: The intervention and the placebo will have the same appearance, and neither the doctor nor the patient will be in the process of taking the intervention or the placebo. 2 Rheumatoid arthritis. 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 chamomile, patients will take two capsules daily with food, the duration of the intervention is 45 days. BTMC-1 medicinal product is edible, this capsule is prepared and produced by Behpad Teb Iranian Company. Intervention 2: Control group: Capsules containing basic ingredients without matricaria chamomile hydroalcoholic extract. Yes - There is a plan to make this available What will be shared: Since it is mentioned that the information remains confidential, it is possible to publish this data file only if it is coded and without inserting the patients' information. When: the data will be accessible by 2025 To whom: The data will be available to people working in scientific and academic centers and institutions Conditions: Individuals will only be allowed to use data to ensure accuracy and verification or to achieve sample size in their studies. Where to obtain: email: natighimahdiyeh@yahoo.com How to obtain: After meeting the mentioned conditions and confirming it by the responsible person, the data will be available within one working week. Comments:
public Mahdiyeh Nateghi
No.1471, Shahed University Research Center Complex, Immunoregulation Research Center, Karghar Shomali St, before Nosrat St
Tehran Iran (Islamic Republic of) 9613478557 +98 21 6636 9225 nateghimahdiyeh@yahoo.com Shahed University scientific Mahdiyeh Nateghi
No.1471, Shahed University Research Center Complex, Immunoregulation Research Center, Karghar Shomali St, before Nosrat St
Tehran Iran (Islamic Republic of) 9613478557 +98 21 6636 9225 nateghimahdiyeh@yahoo.com Shahed University Iran (Islamic Republic of) 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 20 years 65 years Female 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 M05 Seropositive rheumatoid arthritis Treatment - Drugs Treatment - Drugs Intervention group:medicinal product BTMC-1 (capsule prepared from hydroalcoholic extract of Matricaria chamomile), each capsule contains 800 mg of hydroalcoholic extract of Matricaria chamomile, patients will take two capsules daily with food, the duration of the intervention is 45 days. BTMC-1 medicinal product is edible, this capsule is prepared and produced by Behpad Teb Iranian Company. Control group: Capsules containing basic ingredients without matricaria chamomile hydroalcoholic extract 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). 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. Immunoregulation Research Center Approved 2023-01-30 Ethics Committee of Shahed University Shahed University, in front of the Holy Shrine of Imam Khomeini, in the beginning of Tehran-Qom highway ,Tehran Tehran Tehran Iran (Islamic Republic of)