Long-Term Effects of Mobithron Advance on Knee Osteoarthritis Aims to Investigate the Effects of Mobithron Advance on OA Progression

Trial statusRecruiting
Trial phaseEarly Phase 1
Trial typeInterventional
Biological sexAll
Age50+
SponsorUniversiti Sains Malaysia

About this trial

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

Eligibility criteria

Qualifiers

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

Disqualifiers

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).

Trial design

Treatments tested in this trial

  • Type 2 collagen

Treatment groups

84 Participants
are divided into 1 treatment group

Sponsors and collaborators

Universiti Sains Malaysia

Lead sponsor

BREGO Life Sciences Sdn Bhd

Collaborator