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Evaluating the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period

8. juni 2026 opdateret af: University of Malaya

Observational Study to Evaluate the Effectiveness of Mobithron Xtra in Patients With Primary Knee Osteoarthritis Over a 3-month Period

Knee osteoarthritis is a common condition that causes knee pain, stiffness, reduced mobility, and difficulty performing daily activities. Many patients seek non-surgical treatment options to help manage their symptoms and improve their quality of life.

This study aims to evaluate the effectiveness and safety of Mobithron® Xtra, an oral health supplement containing hyaluronic acid, undenatured type II collagen, and Boswellia serrata extract, in adults with primary knee osteoarthritis. Participants will take Mobithron® Xtra once daily for 3 months as part of their routine care.

The study will observe changes in knee pain, stiffness, physical function, treatment satisfaction, and overall perception of improvement using validated patient-reported outcome measures, including the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC), Visual Analogue Scale (VAS), Treatment Satisfaction Questionnaire for Medication (TSQM), and Patient Global Impression of Change (PGIC).

This is a prospective, multicentre observational study involving patients receiving treatment in participating general practitioner clinics throughout Malaysia. No experimental procedures will be performed, and participants will continue to receive standard clinical care. Safety will be monitored throughout the study by documenting any adverse events reported by participants.

The findings from this study may provide valuable real-world evidence regarding the role of Mobithron® Xtra in improving symptoms and quality of life among patients with primary knee osteoarthritis.

Studieoversigt

Status

Ikke rekrutterer endnu

Betingelser

Undersøgelsestype

Observationel

Tilmelding (Anslået)

100

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

  • Navn: Kwong Weng Loh, MBBS, MS Orth, MRCS
  • Telefonnummer: +4407833084270
  • E-mail: melvinloh@um.edu.my

Studiesteder

  • Malaysia
    • Kuala Lumpur
      • Kuala Lumpur, Kuala Lumpur, Malaysia, 50603
        • Faculty of Medicine

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen
  • Ældre voksen

Tager imod sunde frivillige

Ingen

Prøveudtagningsmetode

Ikke-sandsynlighedsprøve

Studiebefolkning

Prospective, multi-centred, observational cohort study, whereby patients fulfilling inclusion and exclusion criteria will be recruited prospectively at general practitioner clinics located throughout Malaysia.

Beskrivelse

Inclusion Criteria:

  • Adults ≥40 years with primary knee osteoarthritis (OA)
  • Radiographic diagnosis of primary knee OA (Grade 2 or 3 on Kellgren-Lawrence scale)
  • Stable physiotherapy regimen for ≥3 months (if applicable).
  • Baseline VAS score ≥ 5
  • No prior surgical intervention for the affected knee

Exclusion Criteria:

  • Secondary OA (such as post-traumatic and inflammatory arthritis)
  • Grade IV Primary OA
  • Patients on analgesia (e.g., paracetamol, NSAIDs)
  • Patients on Mobithron (P/Advance/Xtra) or glucosamine products
  • Recent intra-articular injections within 6 months
  • Recent/planned knee surgery within 3 months
  • Severe comorbidities or cognitive impairment

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

Kohorter og interventioner

Gruppe / kohorte
Mobithron® Xtra

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Effectiveness of Mobithron® Xtra as measured by the WOMAC (Western Ontario and McMaster Universities Osteoarthritis Index)
Tidsramme: From enrolment to the end of treatment at 3 months
The WOMAC is a validated patient-reported outcome measure assessing pain, stiffness, and physical function in individuals with osteoarthritis. The total WOMAC score ranges from 0 to 96 points, with higher scores indicating worse pain, stiffness, and functional impairment (worse outcome) and lower scores indicating better clinical status (better outcome). Effectiveness will be assessed by comparing the change in WOMAC total score from baseline to the end of treatment at 3 months
From enrolment to the end of treatment at 3 months
Effectiveness of Mobithron® Xtra in reducing pain and symptoms of knee OA, as measured by VAS score
Tidsramme: From enrolment to the end of treatment at 3 months
The Visual Analog Scale (VAS) for Pain is a patient-reported measure of pain intensity. Participants rate their pain on a scale ranging from 0 to 10, where 0 represents no pain and 10 represents the worst imaginable pain. Higher scores indicate greater pain severity (worse outcome), while lower scores indicate less pain severity (better outcome). Effectiveness will be assessed by comparing the change in VAS pain scores from baseline to the end of treatment at 3 months.
From enrolment to the end of treatment at 3 months

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Assess treatment satisfaction using Treatment Satisfaction Questionnaire for Medication (TSQM) v1.4
Tidsramme: From enrolment to the end of treatment at 3 months
This section evaluates the effectiveness, side effects, and convenience of the medication taken by the patients, and is evaluated on the likert scale from 1 to 7. A lower score indicates a worse outcome whereas a higher score indicates a better outcome.
From enrolment to the end of treatment at 3 months
Evaluate patients' global impression of change (PGIC)
Tidsramme: From enrolment to the end of treatment at 3 months
The Patient Global Impression of Change (PGIC) is a patient-reported measure that assesses participants' perception of overall change in their condition since starting treatment. Participants rate their overall condition using a 7-point ordinal scale: 1. Very much improved, 2. Much improved, 3. Minimally improved, 4. No change, 5. Minimally worse, 6. Much worse, or 7. Very much worse. Higher levels of improvement indicate a better outcome, while worsening categories indicate a poorer outcome.
From enrolment to the end of treatment at 3 months
Identify progressive trends in range of motion improvement from baseline to Month 3
Tidsramme: From enrolment to the end of treatment at 3 months
Knee range of motion (ROM) will be assessed using a goniometer and recorded in degrees (°). Measurements will be obtained at baseline and at each follow-up visit through Month 3. Effectiveness will be evaluated by assessing the change in ROM over time and identifying progressive trends in knee mobility improvement. Higher ROM values indicate greater joint mobility and a better outcome.
From enrolment to the end of treatment at 3 months
Evaluate the safety profile of Mobithron® Xtra
Tidsramme: From enrolment to the end of treatment at 3 months
Number of participants experiencing treatment-emergent adverse events (TEAEs), serious adverse events (SAEs), and adverse drug reactions (ADRs). The events will be escalated to the research team and recorded in the standardised Adverse Drug Reaction form. All data collected will be monitored continuously throughout the study period.
From enrolment to the end of treatment at 3 months

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Malaya

Samarbejdspartnere

BREGO Life Sciences Sdn Bhd

Publikationer og nyttige links

Den person, der er ansvarlig for at indtaste oplysninger om undersøgelsen, leverer frivilligt disse publikationer. Disse kan handle om alt relateret til undersøgelsen.

Generelle publikationer

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Anslået)

1. juli 2026

Primær færdiggørelse (Anslået)

1. juli 2027

Studieafslutning (Anslået)

1. december 2027

Datoer for studieregistrering

Først indsendt

2. juni 2026

Først indsendt, der opfyldte QC-kriterier

8. juni 2026

Først opslået (Faktiske)

11. juni 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

11. juni 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

8. juni 2026

Sidst verificeret

1. maj 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • 2025924-15624

Plan for individuelle deltagerdata (IPD)

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