Efficacy of INTOFINE-JOINT SUPPORT DIETARY SUPPLEMENT on Bone and Joint Health

The Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) is a 24-item questionnaire that measures knee pain, stiffness, and difficulty with daily activities. Scores range from 0 (no symptoms) to 96 (severe symptoms). The primary endpoint is the change in total score from baseline to the end of the study, to assess overall improvement in knee function.

Knee pain is measured using a 10-point Visual Analog Scale (VAS), where 0 = no pain and 10 = worst possible pain. Participants rate their pain at rest and during daily activities (e.g., walking, climbing stairs). Changes in these scores from baseline are tracked over the intervention period.

The test is conducted in a 20-30 meter flat corridor, with the ambient temperature maintained at 20-25℃ and relative humidity at 40%-60%. Upon instruction, the subject walks continuously for 6 minutes at the maximum tolerable speed. The tester gives a time reminder every minute. If the subject feels significant discomfort, they may rest or terminate the test at any time, and relevant information shall be documented. Once the timing ends, the final position of the subject is recorded, and the total walking distance is calculated.

Reporting method:Change from baseline to Day 28 and Day 56, presented as the mean distance, mean change from baseline, and percentage improvement at each time point.

At the end of the study, participants rate their overall knee symptom improvement using a 5-point scale (1 = much worse, 5 = much better). This self-reported measure captures how participants perceive the effect of the intervention on their daily lives.

1.Test Requirements: Subjects complete 3 consecutive stand-sit movements at a uniform speed without external assistance from handrails, walls or other supports.

2.Evaluation Criteria：

• Excellent: All 3 movements are standard with upright trunk, no body sway or knee pain, and no auxiliary support required.
• Good: All 3 movements are basically standard with occasional slight self-adjustable sway, no knee pain, and no auxiliary support required.
• Pass: Slight knee soreness or obvious body sway occurs during movements, or 1-2 movements require knee support by hands to complete.
• Fail: Unable to complete movements independently, requiring external assistance; or presenting with collapsing sitting posture and obvious lower limb weakness during standing up.

3.Reporting method: Change in sit-to-stand test score from baseline and percentage improvement at each time point.

Subjects complete a stair-climbing test on a 30-step staircase (16 cm per step). Performance is scored on a 4-point scale based on knee pain, stability, and functional ability to assess improvements in joint function and mobility.

Reporting method:Change in sit-to-stand test score from baseline to Day 56, presented as the mean change and percentage improvement from baseline.

Test items: hip external rotation, hip internal rotation, knee flexion and extension Reporting method: Change in hip external rotation, hip internal rotation, knee flexion and extension range of motion (degrees) from baseline to test day, presented as the mean change and percentage improvement from baseline.

Test items:Alanine Aminotransferase (ALT), Aspartate Aminotransferase (AST), Gamma-Glutamyl Transferase（GGT） Reporting method: Changes in each parameter at baseline and Day 56, as well as the proportion of subjects with values exceeding the upper limit of normal range

Test items: Urea (UREA), Creatinine (Cr), Uric Acid (UA) Reporting method: Changes of each parameter at baseline and Day 56, and the proportion of subjects with values exceeding the upper limit of normal range.