A Multicenter, Randomized, Double-Blind, Placebo-Controlled Trial Assessing Efficacy and Safety of a Novel Low-Dose Turmeric Extract Formulation in Healthy Adults with Chronic Knee Pain

Abstract

Background: Knee pain causes functional limitations, eventually compromising the quality of life. We evaluated the efficacy of our water-dispersible turmeric formulation (60% natural curcuminoids, TurmXTRA 60N ® -WDTE60N), which exhibited better PK profile at low dose (250 mg) than standard turmeric extract, in alleviating symptoms of chronic knee pain. Methods: In this randomized, double-blind, placebo-controlled trial, subjects received either 250 mg WDTE60N capsule (150 mg curcuminoids; n = 53) or appearance-matched placebo capsule (n = 53) once daily for 90 days. Primary endpoint was change in pain score on the visual analogue scale (VAS) after 80-m fast-paced walk test. Results: A total of 96 subjects completed the study. WDTE60N reduced VAS score from baseline (5.4 ± 0.9) to day 90 (3.8 ± 0.8) with greater mean reduction than placebo (−1.5 ± 0.7 vs −0.6 ± 0.8, p < 0.0001; 2.5 times). It also significantly improved the time taken for 80m fast-paced walk test and 9-step stair-climb test; and improved all biomarkers compared to placebo (p > 0.05). Three adverse events occurred but were unrelated to study products. Conclusion: WDTE60N 250 mg administered once daily for 3 months, alleviated knee pain, improved joint function in healthy subjects with chronic knee pain, was well tolerated and safe.

Efficacy and Safety of TurmXTRA® 60N in Delayed-onset Muscle Soreness in Healthy, Recreationally Active Subjects: a Randomized, Double-blind, Placebo-controlled Trial

“…The study also demonstrated improvements in joint performance and mobility without any significant safety concern following WDTE60N administration once daily for 3 months. (17) Thus, the results of the previous and present studies reflect that WDTE60N could have beneficial effects on the entire musculoskeletal system with a single daily dose of one capsule.…”

“…Recently, we assessed efficacy of WDTE60N in alleviating symptoms of chronic knee pain. (17) Results of the randomized study confirmed significantly greater pain reduction among those receiving WDTE60N as compared to those receiving placebo as evident by significant reduction in VAS score (−1.5 ± 0.7 vs -0.6 ± 0.8, p < 0.0001). Further, the results for time taken for 80-m fast-paced walk test and 9-step stair-climb test with WDTE60N intake were also satisfactory.…”

Efficacy and Safety of TurmXTRA® 60N in Delayed Onset Muscle Soreness in Healthy, Recreationally Active Subjects: A Randomized, Double-Blind, Placebo-Controlled Trial

“…e pain-alleviating efficacy of WDTE60N was also demonstrated in the management of chronic knee pain. e study also demonstrated improvements in joint performance and mobility without any significant safety concerns following WDTE60N administration once daily for 3 months [17].…”

“…Findings of this study indicate that water dispersibility of WDTE60N aids in the absorption of active moieties resulting in higher levels of plasma-free curcumin, total curcumin, and total curcuminoids compared to standard turmeric extract of 95% when subjects were administered a ten-fold lower quantity of curcuminoids in WDTE60N. Recently, we assessed the efficacy of WDTE60N in alleviating symptoms of chronic knee pain [17]. Results of the randomized study confirmed significantly greater pain reduction among those receiving WDTE60N compared to those, who received placebo as was evident by a significant reduction in VAS score (−1.5 ± 0.7 vs −0.6 ± 0.8, p < 0.0001).…”

Evaluation of Curcumin, Piperine, and Ferrous Sulphate Combination Potential in the Adjuvant-induced Arthritis Model in Male Wistar Rats

“…[35] Previous studies conducted showed that curcumin is beneficial in improving the mobility and stair-climbing ability of patients suffering from RA. [36] It is proven that piperine improves the bioavailability of curcumin, therefore curcumin and piperine in synergism can help in improving the mobility and stair-climbing ability in RA. [37] The study revealed that the combination group improves the mobility and stair-climbing ability as compared to the disease control group in the AIA model.…”