一项评估两种不同剂量MyCondro™对躯体活动能力和关节健康有效性的去中心化临床研究

Participants in this arm will receive a 300 mg daily dose of the supplement, administered as two capsules every morning after breakfast for a 12-week period

This is a non-animal Chondroitin sulfate formulation.

Participants in this arm will receive a 600 mg daily dose of the supplement, administered as two capsules every morning after breakfast for a 12-week period

This is a non-animal Chondroitin sulfate formulation.

To evaluate the effectiveness of two different doses of MyCondro on mobility, activity, and joint health by measuring the change in total WOMAC scores from baseline to the end of the study within each dose group

This outcome evaluates the product's effect on overall joint health and mobility. Efficacy is measured by tracking the change from baseline in both the Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC)-assessing pain, stiffness, and physical function-and the TLKS (Tegner Lysholm Knee Scoring Scale). Data will be collected at 1 month, 2 months, and the end of the study to compare improvements within and between the two dose groups.

This objective specifically assesses the product's impact on acute and chronic pain levels during different physical states. Utilizing a daily numeric rating scale (NRS), the investigators will track the change from baseline in average weekly knee pain scores-both at rest and in motion-comparing the outcomes between the two dosage groups.

This measure captures the participant's personal perception of their symptom relief and overall disease activity. It calculates the change from baseline in the average PGADA (Patient Global Assessment of Disease Activity) score at 1 month, 2 months, and the end of the study to determine if either dose group experiences a more noticeable subjective improvement.

This objective examines the broader, holistic impact of the study product on a participant's daily living and well-being. By comparing baseline Short Form 36 (SF-36) health survey scores to those collected at the study's conclusion, the study investigators can analyze changes in general quality of life between the two doses.

This objective investigates the physiological effects of the study product on underlying inflammation. The study investigators will measure the change from baseline in high-sensitivity C-reactive protein (hs-CRP) levels at the end of the study to evaluate and compare the biochemical impact of the two different doses.

This outcome tracks the ongoing need for supplementary pain relief during the trial. It evaluates the frequency of standard rescue medication use (paracetamol/acetaminophen and oral NSAIDs) during the product use period. This metric tracks the ongoing need for supplementary pain relief, and differences in usage between the dose groups via a daily diary.

This critical measure ensures the study product is safe for consumer use at both the 300mg and 600mg dosages. The study team will track and assess the number, frequency, and severity of all adverse events (AEs), serious adverse events (SAEs), and any trial withdrawals caused by AEs throughout the duration of the product use period.

This outcome evaluates the study product's impact on real-world, daily physical activity. By utilizing a health tracking wearable device, study investigators will continuously measure the change from baseline in objective activity levels for each dose group. This allows for a direct comparison of actual physical movement and exertion between the two doses throughout the study period.

This objective focuses on gathering actionable insights to optimize future decentralized, consumer-driven clinical trials. The study team will evaluate the results of a participant satisfaction survey to assess the overall study experience, specifically focusing on the usability, design, and effectiveness of the app-based data collection tools used during the trial.