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

NCT07323745 | Not Yet Recruiting Early Phase 1

• 1 other identifier: mobithron grant
• Study Type: interventional
• Target: 84
• Locations: 1 country
• Sites: 1

Brief Summary

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

Conditions

Osteoarthritis (OA) of the Knee

Keywords

Mobithron Advance

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (1)

• assessment of pain score in knee osteoarthritic patient

  1 year

Other Outcomes (1)

• functional assessment of patient with osteoarthritic knee included in this study

  1 year

Study Arms (1)

Mobithron Advance Arm

EXPERIMENTAL

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

Interventions

Type 2 collagen DRUG

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.

Also known as: Mobithron Advance

Mobithron Advance Arm

Eligibility Criteria

• Age: 50 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• BREGO Life Sciences Sdn Bhd: collaborator
• Universiti Sains Malaysia: lead

Study Sites (1)

Hospital Univerisiti Sains Malaysia (HUSM)

Kota Bharu, Kelantan, 16150, Malaysia

Location

Related Publications (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.

  PMID: 24153020 BACKGROUND

• 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.

  PMID: 18208600 BACKGROUND

• 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.

  PMID: 19847319 BACKGROUND

Related Links

• Related Info

MeSH Terms

Conditions

Osteoarthritis

Condition Hierarchy (Ancestors)

Arthritis; Joint Diseases; Musculoskeletal Diseases; Rheumatic Diseases

Central Study Contacts

Mohamad Anas Alfian Bin Sufri Dr., Medicine and Surgery

CONTACT

+60192993482; anas.alfian92@gmail.com

Study Design

• Study Type: interventional
• Phase: early phase 1
• Allocation: NA
• Masking: NONE
• Purpose: TREATMENT
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Professor

Model Details: This Mobithron study uses a prospective, single-arm interventional clinical trial model, where all patients will receive Mobithron Advance daily for 12 months. This design allows you to follow participants forward in time and directly assess the effects of the intervention on knee osteoarthritis outcomes, including cartilage preservation, pain reduction, functional improvement, and safety. The single-arm approach is suitable for an early-stage study of a novel therapeutic, focusing on generating essential safety and efficacy data before progressing to randomised controlled trials. By including patients across Kellgren-Lawrence grades 1-3, the study also explores how disease severity influences treatment response.

Study Record Dates

• First Submitted: December 7, 2025
• First Posted: January 7, 2026
• Study Start: December 30, 2025
• Primary Completion (Estimated): December 31, 2026
• Study Completion (Estimated): October 31, 2027
• Last Updated: January 7, 2026

Record last verified: 2025-12

Locations

MY (1)