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IRCT20250515065755N1 IRCT 2025-05-29 Zabol University of Medical Sciences Effects of artichoke leaf extract in knee osteoarthritis Effects of artichoke leaf extract supplementation on oxidative stress status, inflammatory markers and clinical symptoms in patients with knee osteoarthritis 2025-07-23 anticipated 46 Complete https://irct.ir/trial/83795 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Used, Assignment: Parallel, Purpose: Supportive, Randomization description: The participants will be randomly assigned to study groups using a block randomization procedure of size 4 and will be stratified by sex, age, and BMI. The Random Allocation Software (RAS) will be used by the study statistician to generate a random sequence, Blinding description: In this study, both participants and the principal investigator will be blinded to the study groups. To ensure that researchers and participants remain unaware of the type of supplement being administered, both the supplement and placebo will be placed in identical containers labeled with the appropriate code by an individual who is not the investigator, following a predetermined coding system. N/A Knee osteoarthritis. Intervention 1: Intervention group: 1800 mg artichoke leaf extract as 4 tablets per day for 12 weeks. Intervention 2: Control group: 1800 mg placebo containing corn starch as 4 tablets per day for 12 weeks. No - There is not a plan to make this available Justification or reason for not sharing IPD is There is no further information.
public Farshad Amirkhizi
Shahid Bagheri Ave., Shahid Rajaee St.
Zabol Iran (Islamic Republic of) 9861615881 +98 54 3223 2190 amirkhizi@zbmu.ac.ir Zabol University of Medical Sciences scientific Farshad Amirkhizi
Shahid Bagheri Av., Shahid Rajaee St.
Zabol Iran (Islamic Republic of) 9861615881 +98 54 3223 2190 amirkhizi@zbmu.ac.ir Zabol University of Medical Sciences Iran (Islamic Republic of) Willingness and ability to collaborate on project aged 40-70 years from both sex Confirmation of bilateral primary knee osteoarthritis Body mass index between 25-35 kg/m2 Consumption of glucoseamine, chondroitin sulfate supplements and acetaminophen as anti-pain drug 40 years 70 years Both Alcohol consumption Smoking Pregnant and lactating women Secondary osteoarthritis Having an active synovitis Having a history of knee injection within 6 months before intervention Neurological disorder that affects movement, muscle control and balance Affected by cardiovascular disease, renal failure, diabetes mellitus, liver dysfunction, cancer; affected by infectious or inflammatory disease or recent surgery Consumption of Furosemide, Probenecid, Anticoagulants, Anticonvulsant drugs, Sulphonamides, Methotrexate, Lithium salts and muscle relaxants currently or within 3 months before intervention Consumption of fish oil supplement or other antioxidant supplements currently or within 3 months before intervention History of allergy to artichoke family plants and their products M17 Osteoarthritis of knee Treatment - Other Placebo Intervention group: 1800 mg artichoke leaf extract as 4 tablets per day for 12 weeks Control group: 1800 mg placebo containing corn starch as 4 tablets per day for 12 weeks Pain. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: WOMAC questionnaire. Joint stiffness. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: WOMAC questionnaire. Disability. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: WOMAC questionnaire. Oxidative markers. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Total antioxidant capacity (TAC) by using spectrophotometry, MDA by using thiobarbituric acid, Total oxidant capacity by using ELISA kit. Inflammatory markers. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Serum levels of TNF-α، IL-1β and IL-6 by using ELISA kits. Anthropometric measurements. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: Weight and Height by using Seca scale and stadiometer respectively, waist circumference by using tape measure, Body mass index (BMI) will be calculated as weight in kilograms divided by the square of height in meters. Energy and macro-nutrients intake. Timepoint: Baseline and 12 weeks after intervention. Method of measurement: 3-day 24 hours food recall. Zabol University of Medical Sciences Approved 2025-03-04 Ethics Committee of Zabol University of Medical Sciences Shahid Bagheri Ave, Shahid Rajaei St Zabol Sistan-va-Balouchestan Iran (Islamic Republic of)