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

Recruiting · NCT07323745 · Interventional (participants receive a specific treatment) · Lead sponsor: Universiti Sains Malaysia

View the official record on ClinicalTrials.gov →

Osteoarthritis

Interventions studied

Type 2 collagen

What this trial is about

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

Who can take part

Age range

50 Years and older

Sex

All (male and female)

Healthy volunteers

No - a diagnosis or condition is required

Phase

Early Phase 1

Study type

Interventional (participants receive a specific treatment)

Inclusion criteria

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

Exclusion criteria

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).
Patients planning for knee surgery within the research period.
Patients on pharmacological treatment for osteoarthritis, other than rescue analgesic agent, e.g: glucosamine, chondroitin, oral steroid

Where it is running

1 location listed.

Hospital Univerisiti Sains Malaysia (HUSM) - Kota Bharu, Kelantan, Malaysia

Read the full protocol, contacts and eligibility on ClinicalTrials.gov →