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IRCT20230202057310N11 IRCT 2024-12-22 Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan Undenatured collagen type 2 supplementation and knee strengthening exercises in knee osteoarthritis Synergistic effect of undenatured collagen type 2 supplementation and knee strengthening exercises in knee osteoarthritis 2025-01-05 anticipated 377 Complete https://irct.ir/trial/80825 interventional Randomization: Randomized, Blinding: Double blinded, Placebo: Not used, Assignment: Parallel, Purpose: Treatment, Randomization description: This randomization will be done by computer-generated numbers to ensure fairness. Medications will be given in numbered white boxes, each with a unique medication number. The treatment codes will be kept by the principal investigator, Blinding description: Statistical analyser and outcome assessor will be kept blind so that the result obtained will be without biasness. 1 Knee osteroarthritis. Intervention 1: Intervention group: Will receive 40 mg/day of undenatured collagen type II supplementation. Intervention 2: Intervention group: Will be given a standardized knee-strengthening exercise program [specify duration and frequency, e.g., three times per week for 45 minutes].The knee-strengthening exercise program focused on improving muscle strength, joint stability, and functional mobility. It included:• Warm-up: [e.g., 5 minutes of light cycling or walking].• Strengthening exercises: Quadriceps setting, hamstring curls, straight leg raises, and step-ups. Each exercise was performed in sets of 10 repetitions with progressive intensity over the study period.• Cool-down: [specify activities, e.g., 5 minutes of stretching or slow walking].Participants were supervised by trained physiotherapists to ensure adherence and proper technique. Intervention 3: Intervention group: Will recieve UC-II supplementation and participated in the knee-strengthening exercise program. 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 N/A
public Maliha Khalid Khan
Multan
MULTAN Pakistan 66000 +92 333 6120602 malihatareen1997@gmail.com Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan. scientific Imran Ahmad Khan
Old shuja Abad road Multan
Multan Pakistan 66000 +92 333 6120602 imran.ahmad@mnsuam.edu.pk Muhammad Nawaz Sharif University of Agriculture Multan Pakistan Adults aged between 35–65 years. Diagnosed with mild-to-moderate knee osteoarthritis based on: Radiographic confirmation (Kellgren-Lawrence grade :1–3). Experiencing knee pain for at least 3 months Able to perform physical activity and follow an exercise regimen Willing to take undenatured collagen type II supplementation as prescribed Not taking any other osteoarthritis-related medications or willing to maintain a washout period of at least 2 weeks prior to enrollment Provided written informed consent to participate in the study. 35 years 65 years Both 1. Diagnosed with severe knee osteoarthritis (Kellgren-Lawrence grade 4). History of knee surgery or any intra-articular injections (e.g., corticosteroids, hyaluronic acid) in the past 6 months. Currently using immunosuppressive therapy or corticosteroids Pregnancy, breastfeeding, or planning to become pregnant during the study Presence of serious systemic diseases Known allergy or intolerance to collagen supplements or any ingredients in the intervention product Presence of other types of arthritis such as rheumatoid arthritis, gout, or infectious arthritis. M19.0 Primary osteoarthritis of other joints Treatment - Drugs Rehabilitation Other Intervention group: Will receive 40 mg/day of undenatured collagen type II supplementation. Intervention group: Will be given a standardized knee-strengthening exercise program [specify duration and frequency, e.g., three times per week for 45 minutes].The knee-strengthening exercise program focused on improving muscle strength, joint stability, and functional mobility. It included:• Warm-up: [e.g., 5 minutes of light cycling or walking].• Strengthening exercises: Quadriceps setting, hamstring curls, straight leg raises, and step-ups. Each exercise was performed in sets of 10 repetitions with progressive intensity over the study period.• Cool-down: [specify activities, e.g., 5 minutes of stretching or slow walking].Participants were supervised by trained physiotherapists to ensure adherence and proper technique. Intervention group: Will recieve UC-II supplementation and participated in the knee-strengthening exercise program. Osteophytes. Timepoint: 12 weeks. Method of measurement: Knee Xray. Pain, stiffness and ADLs. Timepoint: 12 weeks. Method of measurement: NPRS and WOMAC Scale. Knee ROM. Timepoint: 12 weeks. Method of measurement: Goniometry. Knee injury outcome. Timepoint: 12 weeks. Method of measurement: Knee injury outcome score (KOOS). Quality of life. Timepoint: 12 weeks. Method of measurement: SF-36. Muhammad Institute of Medical and Allied Sciences, Multan, Pakistan Approved 2024-11-21 The Institutional Ethical Committee of Muhammad Institute of Medical and Allied Sciences Bosan Road Multan Punjab Pakistan