Studying Daily Mobithron Advance Tablets for Adults Over 50 With Knee Osteoarthritis to Slow Disease Progression and Assess Safety
Led by Universiti Sains Malaysia · Updated on 2026-06-12
84
Participants Needed
1
Research Sites
43 weeks
Total Duration
AI-Summary
What this Trial Is About
Researchers are studying the long-term effects of Mobithron Advance, an oral drug containing undenatured type II collagen, on knee osteoarthritis OA in adults over 50 years old. The trial aims to find out if this drug can slow the progression of OA with Kellgren-Lawrence grade 1 to 3 and to evaluate its safety and long-term impact compared to a placebo. The study is conducted as an early phase 1, single-group trial at the Orthopaedic Clinic of Hospital Universiti Sains Malaysia.
Participants will take one Mobithron Advance tablet daily for 12 months. They will undergo assessments including MRI scans at the start, 6 months, and 12 months to measure cartilage thickness in the knee. Pain will be monitored monthly using the Visual Analogue Scale VAS, and physical function will be evaluated with the WOMAC index during follow-up visits at 3, 6, and 12 months. Safety monitoring will include tests of kidney function and recording any adverse events.
During the study, participants will have baseline assessments before starting treatment, with follow-up clinic visits every 3 months to assess outcomes and monitor safety. Data collected will cover demographics, clinical results, and imaging findings. Researchers will analyze changes in cartilage thickness, pain levels, physical function, and kidney health over the one-year period to understand how Mobithron Advance affects OA progression and safety.
CONDITIONS
Brief Title
Long-Term Effects of Mobithron Advance on Knee Osteoarthritis Aims to Investigate the Effects of Mobithron Advance on OA Progression
Research Team
M
Mohamad Anas Alfian Bin Sufri Dr., Medicine and Surgery
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Males and female patients above 50 years old at the time of recruitment.
Patients with one or both knee osteoarthritis according to clinical and radiological criteria of the American College of Rheumatology (ACR).
Kellgren Lawrence grade 1 to 3 osteoarthritis.
You will not qualify if you...
Secondary arthritis such as rheumatoid arthritis or psoriatic arthritis.
History of joint surgery.
Steroid injection treatment within the last 3 months.
Hyaluronic acid injection treatment within the last 6 months.
Contraindications to Mobithron Advance, including known allergies or severe liver or kidney disease.
Planned knee surgery during the study period.
Use of pharmacological osteoarthritis treatments other than rescue analgesics, such as glucosamine, chondroitin, or oral steroids.
Your Study Journey
Screening
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
1 visit (in-person)
Treatment
Duration - 12 months
Participants take one Mobithron Advance oral tablet daily for 12 months to study its effects on knee osteoarthritis.
Clinic visits at baseline, 3 months, 6 months, and 12 months
Follow-up
Duration - 12 months (concurrent with treatment)
Participants undergo assessments including MRI scans to measure cartilage thickness, pain scores, physical function tests, and safety monitoring throughout and at the end of treatment.
Monthly pain assessments and scheduled clinic visits
How is the study designed?
Study Type
INTERVENTIONAL
Masking
NONE
Allocation
NA
Model
SINGLE_GROUP
Primary Purpose
TREATMENT
Number of Arms
1
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Published Research Related To This Trial
Effect of a natural extract of chicken combs with a high content of hyaluronic acid (Hyal-Joint) on pain relief and quality of life in subjects with knee osteoarthritis: a pilot randomized double-blind placebo-controlled trial.