Safety and Efficacy of Moderately-High Dose Turmacin® (Turmerosaccharide >10% w/w) Supplementation on Joint Discomfort in Healthy Adults - A Pilot Proof-of-Concept Single Arm Study.

Turmeric is well-known for its analgesic, anti-inflammatory and anti-arthritic properties but 69.4% of the turmeric rhizome contains Turmerosaccharides whose clinical benefit is still unexplored. Turmacin®/NR-INF-02 is an aqueous extract of Turmeric containing Turmerosaccharides (>10%w/w) with negligible curcuminoids. Previous study with low dose Turmacin® confirmed its safety and efficacy in alleviating induced knee pain in healthy volunteers. Hence, this study aimed to assess the safety and explore the efficacy of moderately high dose Turmacin®. It was an open-label, single-arm interventional trial conducted from August 2018 - January 2019 in a tertiary care teaching hospital. Turmacin® was administered for seven days to 15 healthy volunteers as four capsules of 500 mg each in the morning with food. The stair mill at a speed of 60 steps per minute was used to induce knee pain and Visual Analogue Scale (VAS) was used to measure the pain intensity. Assessments were performed at baseline, Days 5 and 7. One participant reported dyspepsia of mild grade that resolved on its own. When compared to baseline, time to initial discomfort significantly increased on Day-5 (Mean Difference [MD] = 30s, p  = 0.016) and Day-7 (MD = 32s, p  = 0.007). Whereas the maximum VAS score decreased with time and on Day-7 and it was significantly low when compared with baseline (MD = -0.93, p  = 0.008). In summary, Turmacin® supplements given at a dose of 2 g/day was safe and tolerable. Similar to the previous study with low dose Turmacin®, there was a significant increase in pain threshold and decrease in the maximum pain score post intervention.