Clinical Pharmacology: Advances and Applications (May 2021)
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
Shefali Thanawala,1 Rajat Shah,1 Venkateswarlu Somepalli,2 KrishnaRaju Venkata Alluri,2 Prabakaran Desomayanandam,3 Arun Bhuvanendran3 1Inventia Healthcare Ltd., Mumbai, Maharashtra, India; 2Laila Nutraceuticals, Vijayawada, Andhra Pradesh, India; 3In vitro Research Solutions (iVRS) Pvt Ltd, Bengaluru, Karnataka, IndiaCorrespondence: Shefali ThanawalaInventia Healthcare Ltd., Mumbai, Maharashtra, IndiaTel +91 9324210054Email [email protected]: 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 80-m 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.Keywords: biomarkers, chronic pain, curcuminoids, knee joint, turmeric, visual analog scale
