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

Long-Term Effects of Mobithron Advance on Knee Osteoarthritis

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

Study Overview

• Status: Not yet recruiting
• Conditions: Osteoarthritis (OA) of the Knee
• Intervention / Treatment: Drug: Type 2 collagen

Detailed Description

The study will be conducted as a prospective single-arm trial with a one-year follow-up at the Orthopaedic Clinic, Hospital Universiti Sains Malaysia (HUSM), Malaysia. Participants will include adults over 50 years old diagnosed with primary knee osteoarthritis (OA) of Kellgren-Lawrence grade 1 to 3, based on clinical and radiological criteria. A total of 84 patients will be recruited, accounting for a 10% dropout rate, and will receive daily oral Mobithron Advance for 12 months. Pain will be assessed monthly using the Visual Analogue Scale (VAS) and physical function will be evaluated with the WOMAC index at follow-up visits. Cartilage preservation will be measured through MRI scans at baseline, six months, and twelve months, using a cartilage-specific 3D WATSc sequence to monitor central femoral condyle thickness. Safety and tolerability will be assessed by monitoring renal function, including creatinine and eGFR, alongside recording any adverse events. Data will include demographics, clinical outcomes, and radiological findings, and will be analysed using descriptive statistics, paired t-tests or Wilcoxon signed-rank tests, and linear mixed-effects models to evaluate changes over time.

• Study Type: Interventional
• Enrollment (Estimated): 84
• Phase: Early Phase 1

Contacts and Locations

• Study Contact: Name: Mohamad Anas Alfian Bin Sufri Dr., Medicine and Surgery; Phone Number: +60192993482; Email: anas.alfian92@gmail.com

Study Locations

• Malaysia
  • Kelantan
    • Kota Bharu, Kelantan, Malaysia, 16150
      • Hospital Univerisiti Sains Malaysia (HUSM)
      • Contact: Amran A Shokri Prof. Dr, master in orthopedics; Phone Number: +60 12-900 9272; Email: amrankb@usm.my
      • Contact: Mohammad Anas Alfian Bin Sufri Dr., Bachelor of Medicine & Surgery; Phone Number: +60 19-299 3482
      • Sub-Investigator: Muhammad Rajaei Ahmad @ Mohd Zain
      • Sub-Investigator: Fattah Rahiman Ghazali

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Treatment
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Mobithron Advance Arm; Treatment Arm will receive one Mobithron Advance oral tablet daily for 12 months. Outcomes will be assessed include cartilage preservation (MRI), pain (VAS), function (WOMAC), and safety (renal function and adverse events)

Drug: Type 2 collagen; This 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.; Other Names: Mobithron Advance

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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.	1 year

Secondary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Other Outcome Measures

Outcome Measure	Measure Description	Time Frame
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	1 year

Collaborators and Investigators

• Sponsor: Universiti Sains Malaysia
• Collaborators: BREGO Life Sciences Sdn Bhd

Publications and helpful links

General Publications

• Kalman DS, Heimer M, Valdeon A, Schwartz H, Sheldon E. 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. Nutr J. 2008 Jan 21;7:3. doi: 10.1186/1475-2891-7-3.
• Lugo JP, Saiyed ZM, Lau FC, Molina JP, Pakdaman MN, Shamie AN, Udani JK. Undenatured type II collagen (UC-II(R)) for joint support: a randomized, double-blind, placebo-controlled study in healthy volunteers. J Int Soc Sports Nutr. 2013 Oct 24;10(1):48. doi: 10.1186/1550-2783-10-48.
• Crowley DC, Lau FC, Sharma P, Evans M, Guthrie N, Bagchi M, Bagchi D, Dey DK, Raychaudhuri SP. Safety and efficacy of undenatured type II collagen in the treatment of osteoarthritis of the knee: a clinical trial. Int J Med Sci. 2009 Oct 9;6(6):312-21. doi: 10.7150/ijms.6.312.

Helpful Links

• Related Info

Study record dates

Study Major Dates

• Study Start (Estimated): December 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027

Study Registration Dates

• First Submitted: December 7, 2025
• First Submitted That Met QC Criteria: December 31, 2025
• First Posted (Actual): January 7, 2026

Study Record Updates

• Last Update Posted (Actual): January 7, 2026
• Last Update Submitted That Met QC Criteria: December 31, 2025
• Last Verified: December 1, 2025

More Information

Terms related to this study

• Keywords: Mobithron Advance
• Additional Relevant MeSH Terms: Musculoskeletal Diseases; Arthritis; Joint Diseases; Rheumatic Diseases; Osteoarthritis
• Other Study ID Numbers: mobithron grant

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: UNDECIDED
• IPD Plan Description: to protect participant personal data

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No