Undenatured Type II Collagen for Knee Osteoarthritis Pain (Three-Arm Trial)

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This randomized, double-blind, three-arm trial compares Nuvicol II, Nuvicol SII, and placebo in adults with knee osteoarthritis and persistent knee pain. Over 4 months, participants will take one capsule daily and undergo regular visits to assess pain, function, biomarkers, and safety. Primary outcome is knee pain on a visual analog scale, with secondary measures including KOOS, WOMAC, muscle function, analgesic use, and cartilage degradation biomarkers. Safety labs and adverse events are monitored throughout the study. The trial is conducted at UCAM HiTech in Murcia and is led by Universidad Católica San Antonio de Murcia.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Age over 30 years.
* Subjects diagnosed with osteoarthritis with functional grades I-III according to the modified American College of Rheumatology criteria.
* Persistent knee pain associated with osteoarthritis with a baseline VAS pain assessment score of at least 30 mm.
* Subjects must not have narcotic or steroidal anti-inflammatory drugs or immunosuppressants in their treatment.

Exclusion Criteria:

* Serious or terminal illnesses.
* Allergy or hypersensitivity to any component of the product under study.
* Vegan or vegetarian diet.
* Current use of glucosamine, chondroitin sulfate, collagen, hyaluronic infiltrations, or any supplement indicated for joint health.
* Chronic inflammatory diseases affecting the musculoskeletal system, including rheumatoid arthritis, gout, pseudogout, Paget disease, or chronic pain syndrome.
* Body mass index above 32 kg/m2.
* Participation in any other research during the last 3 months.
* Pregnant, planning pregnancy during the study, lactating, or breastfeeding.
* Biological childbearing potential without continuous effective contraception as determined by the investigator.
* Inability to understand the research study.

Where it's running

• UCAM HiTech - Unidad de Estudios Clínicos
  Murcia, Murcia, Spain Recruiting

Study contacts

• Principal investigator: Javier Marhuenda, PhD — Universidad Católica San Antonio de Murcia
• Study coordinator: Javier Marhuenda, PhD
• Email: jmarhuenda@ucam.edu
• Phone: +34 618

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.