Knee osteoarthritis. Unilateral primary osteoarthritis, unspecified knee
Conditions
Interventions
Intervention 1: Intervention group: Participants used one sachet of Naturagen® 4 Joint product daily for 8 weeks. Intervention 2: Control group: Participants used a placebo product with the same appea
Sponsors
Ondokuz Mayis University
Eligibility
Sex/Gender
All
Age
35 Years to 65 Years
Inclusion criteria
Inclusion criteria: Diagnosed with unilateral or bilateral Kellgren and Lawrence radiographic grade 2 or 3 knee OA for more than 3 months Non-vegetarian Willing to participate in all scheduled visits and tests
Exclusion criteria
Exclusion criteria: Kellgren and Lawrence diagnosed with radiographic grade 1 or 4 knee OA Any history of trauma, fracture or surgery on the index joint Evidence or history of clinically significant hematologic, renal, endocrine, pulmonary, gastrointestinal, cardiovascular, hepatic, neurologic diseases or malignancies within the last 5 years History of hypersensitivity to the rescue medication or any of the products used in the study Active viral or bacterial infection according to clinical examination Expected knee arthroscopy or arthroplasty or life-threatening pathology Received intra-articular injections or corticosteroids in the target knee joint (the most painful knee at screening) within the last 6 months Patients with intolerance to protein-based foods or supplements, pregnant or breastfeeding women and those with alcohol dependence
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Pain Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Western Ontario and McMaster Universities Osteoarthrtis Index (WOMAC), Visual Analogue Scale (VAS).;Quality of Life Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Knee Injury and Osteoarthritis Outcome Score Physical Function Short Form (KOOS-PS), Oxford Knee Score (OKS), Tampa Scale for Kinesiophobia (TSK), Short Form Health Survey (SF-12), Foot Function Index (FFI).;Balance Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Berg Balance Scale (BBS).;Functional Performance Assessment. Timepoint: Pre-intervention and after 8 weeks of intervention. Method of measurement: Timed Up and Go (TUG), 6-Minute Walking Test (6MWT), The Five Repetition Sit to Stand Test (5STS), Stair-Climbing Test (SCT). | — |
Countries
Turkey
Contacts
Public ContactAli Kerim Yilmaz
Ondokuz Mayis University
Outcome results
None listed