Efficacy and safety investigation of LIMAN technology based curcumin formulation on knee osteoarthritis: a randomized double-blind placebo-controlled trial

Introduction

Knee osteoarthritis is the most common and extensively studied form of osteoarthritis, with varying prevalence reported across studies. Although the presentation of knee osteoarthritis can differ among individuals, it typically manifests as joint pain, stiffness, and restricted mobility, often accompanied by muscle weakness and balance issues. The present clinical study aimed to evaluate the safety and efficacy of Maxicuma®, a highly bioavailable form of curcumin, made from ethanolic extract of turmeric, at two different doses in reducing the symptoms and improving the functional status in individuals with knee osteoarthritis.

Methods

A total of 180 subjects with knee osteoarthritis as per NICE criteria were recruited into the study and severity of either Grade II or Grade III was assessed by radiographic analysis as per Kellgren-Lawrence (KL) scale. Participants received a daily single dose of either placebo, Maxicuma 100 or Maxicuam 250 per day for 90 days. Efficacy was assessed using WOMAC (Western Ontario and McMaster Universities Arthritis Index), VAS (Visual analog scale) and treadmill walk test to understand severity, intensity of pain and physical performance respectively, at day 30, day 45, day 60 and day 90.

Results

The test item was well tolerated with no major adverse events reported. A total of 180 and 174 subjects were considered for intention-to-treat and per-protocol analysis, respectively. Both doses of Maxicuma® demonstrated statistical significance (p < 0.05) compared to placebo starting from day 30 across all efficacy measures.

Conclusion

Findings from this clinical study indicate that Maxicuma® 100 mg and 250 mg are effective and well-tolerated supplement options for managing knee osteoarthritis. Both dosages showed potential in improving clinical symptoms and enhancing functional outcomes.