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IRCT20120415009472N29 IRCT 2025-03-15 Iran University of Medical Sciences The effect of bromelain and curcumin on rheumatoid arthritis The effect of Bromelain supplementation alone and in combination with Curcumin on disease symptoms and severity, inflammatory markers and oxidative stress in patients with Rheumatoid Arthritis 2025-04-21 anticipated 75 Complete https://irct.ir/trial/82106 interventional Randomization: Randomized, Blinding: Triple blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: In this study, samples will be selected based on availability, and randomization will be performed for group allocation. For randomization, a random list for three groups, each with a sample size of 25 participants, was generated using web-based software. The letters A, B, and C will be assigned to the numbers 1 to 3 using random number generation. The numbers 1 to 3 correspond to the three groups: Group 1 (Bromelain), Group 2 (Bromelain + Curcumin), and Group 3 (Placebo). Based on the order of patient visits, the type of intervention, represented by letters A, B, and C, will be assigned to each patient according to the sequential list generated by the random number software. Patient selection will initially be based on their visits, making it a convenience sample, but drug allocation will be randomized, Blinding description: This study is a triple-blind, placebo-controlled randomized clinical trial, meaning that the patient, the researcher, and the analysts performing the statistical analyses will remain unaware of the type of intervention until the analysis is completed. The pharmacist will attach labels A, B, and C to the medication packages, which will be provided to patients visiting the therapist according to the sequential list generated by the random number program. After the completion of the analysis and the review of the results, the pharmacist will be contacted to disclose the label assignments. This information will then be used in the preparation of the report and the manuscript, particularly in the findings, discussion, and conclusion sections. 3 Rheumatoid arthritis. Intervention 1: Intervention Group 1:A total of 25 participants in this group will receive bromelain, taking two 200 mg bromelain capsules daily (one with breakfast and one with lunch) for 12 weeks. The capsules will be provided by Salamat Parmon Amin (SPAmeda) Company. Intervention 2: Intervention Group 2:A total of 25 participants in this group will receive a combination of bromelain and curcumin, taking two capsules daily, each containing 200 mg of bromelain and 300 mg of curcumin (one with breakfast and one with lunch) for 12 weeks. The capsules will be provided by Salamat Parmon Amin (SPAmeda) Company. Intervention 3: Control Group:A total of 25 participants in this group will receive a placebo, taking two capsules daily containing maltodextrin (identical in appearance, color, smell, and taste to the intervention capsules but with no therapeutic effect), one with breakfast and one with lunch, for 12 weeks. The capsules will be provided by Salamat Parmon Amin (SPAmeda) Company. 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 more information
public Naheed Aryaeian
Nutrition department, school of public health, Hemmat broad way
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4750 aryaeian.n@iums.ac.ir Iran University of Medical Sciences scientific Naheed Aryaeian
Nutrition department, school of public health, Hemmat broad way
Tehran Iran (Islamic Republic of) 1449614535 +98 21 8670 4750 aryaeian.n@iums.ac.ir Iran University of Medical Sciences Iran (Islamic Republic of) Diagnosis of Rheumatoid Arthritis Based on American College of Rheumatology (ACR) Criteria(If there are at least four criteria for six weeks of the criteria 1- Morning dryness for at least one hour in three joints or more 2- Arthritis of three joint areas or more 3- Arthritis of the hand joints 4- Symmetric arthritis 5- Rheumatoid nodules 6- Positive rheumatoid factor 7- Typical radiographic changes in the wrist and hand) The duration of the disease should be at least two years. The patient expresses his / her consent to participate in the study 18 years 65 years Both Taking supplements (omega 3, antioxidants, etc.) in the last two months Having any of the diseases of diabetes, hypertension, thyroid disorder and kidney failure and Liver dysfunction Changes in the amount of medication taken in the past month Pregnancy and lactation Taking contraceptives People who are allergic to pineapple, carrots, and fennel. People who take anticoagulant medications. Substance abuse M05 Rheumatoid arthritis with rheumatoid factor Treatment - Drugs Treatment - Drugs Placebo Intervention Group 1:A total of 25 participants in this group will receive bromelain, taking two 200 mg bromelain capsules daily (one with breakfast and one with lunch) for 12 weeks. The capsules will be provided by Salamat Parmon Amin (SPAmeda) Company. Intervention Group 2:A total of 25 participants in this group will receive a combination of bromelain and curcumin, taking two capsules daily, each containing 200 mg of bromelain and 300 mg of curcumin (one with breakfast and one with lunch) for 12 weeks. The capsules will be provided by Salamat Parmon Amin (SPAmeda) Company. Control Group:A total of 25 participants in this group will receive a placebo, taking two capsules daily containing maltodextrin (identical in appearance, color, smell, and taste to the intervention capsules but with no therapeutic effect), one with breakfast and one with lunch, for 12 weeks. The capsules will be provided by Salamat Parmon Amin (SPAmeda) Company. Tumour necrosis factor- α (TNF-α). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Total antioxidant capacity (TAC). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Chromatography. Erythrocyte sedimentation rate (ESR). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Westergren method. Malondialdehyde (MDA). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Chromatography. Interferon gamma (IFN-γ). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). Interleukin-17 (IL-17). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Enzyme-linked immunosorbent assay (ELISA). C-reactive protein (CRP). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Immunoturbidometric method. Disease activity score. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Formula DAS28. Illness severity. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Physician global assessment. Pain. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Visual analogue scale. Morning stiffness. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: How long (minutes) it takes for the joint dryness to go away. Number of painful joints. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Doctor's examination. Tender joint counts (TJC). Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Doctor's examination. Swollen joint count. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Doctor's examination. Dosage of drugs. Timepoint: Before the intervention and after the end of the intervention. Method of measurement: Questionnaire. Iran University of Medical Sciences Approved 2025-02-23 Research Ethics Committees of Iran University of Medical Sciences Iran University of Medical Sciences Hemat Highway, Between Sheikh Fazlollah Nouri Highway and Shahid Chamran Highway, Next to Milad Tower, Tehran, Iran Tehran Tehran Iran (Islamic Republic of)