The goal of this clinical trial is to learn if the Mobithron Advance drug works to treat and slow the progression of osteoarthritis (OA) in patients. It will also learn about the safety and long-term effects of this drug. The main questions it aims to answer are:
* Does long-term administration of Mobithron Advance can modify the progression of knee osteoarthritis with Kellgren-Lawrence grade 1 to 3 in HUSM patients? * Does long term usage of Mobithron Advance has safety profile? Researchers will compare the Mobithron Advance drug to a placebo (a look-alike substance that contains no drug) to see if said drug works to treat OA.
Participants will:
* Undergo pre-study assessment (baseline assessments) during first visit * Take oral Mobithron Advance daily for 1 year * Visit the clinic once at 3 months, 6 months and 12 months intervals from the initial visit for follow up assessments
Males and female patients above 50 years old at the time of recruitment.
OA Diagnosis: Patients with one or both knee osteoarthritis according to clinical and radiological criteria of the American College of Rheumatology (ACR).
OA Grade: Kellgren Lawrence grade 1-3
Secondary arthritis (e.g., rheumatoid arthritis, psoriatic arthritis).
History of joint surgery.
Patients who received steroid injection treatment within the last 3 months or hyaluronic acid injection treatment within the last 6 months.
Contraindications to Mobithron Advance (e.g., known allergies, severe liver or kidney disease).
Single group
Type 2 collagen
DrugThis study's intervention is undenatured type II collagen (UC-II) oral tablets, one daily for 12 months, targeting knee osteoarthritis (KL grade 1-3). It differs from other interventions such as glucosamine, chondroitin, hyaluronic acid, or NSAIDs by working through an oral tolerance mechanism with the potential to preserve cartilage and modify disease progression, rather than providing only short-term symptom relief.
to assess the thickness of cartilage in osteoarthritic knee included in the study at 3 stages. pre treatment, mid treatment and post treatment.
in term of cartilage assessment, MAGNETIC RESONANCE IMAGING (MRI) PROTOCOL is going to be used; in which, Multiplanar reconstruction (MPR) of the 3D WATSc image will be done to determine the location of central medial femoral condyle cartilage, where thickness of the central medial femoral condyle (cMF) cartilage will be measured on sagittal plane at the most central weight bearing surface. with the above outcome measure, the study can look into Mobithron able to preserve and regenerate cartilages in patients, slowing and reversing cartilage losses as well as disease progression.
assessment of pain score in knee osteoarthritic patient
The outcomes is measured using visual analogue score (VAS) for pain intensity assessment at 3 months interval
functional assessment of patient with osteoarthritic knee included in this study
WOMAC osteoarthritis index is going to be used to assess the functionality of the patient with osteoarthritic knee included in the study, assessment is done every 3 months durint the study period
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Universiti Sains Malaysia
Lead sponsor
BREGO Life Sciences Sdn Bhd
Collaborator
