Background Curene® is a bioavailable formulation of turmeric  Curcucma longa extract comprising naturally derived curcuminoids formulated with proprietary Aquasome® technology. Curcuminoids were found to have anti-inflammatory properties by inhibiting Cyclooxygenase-2 (COX-2) and 5-lipoxygenase (5-LOX) enzyme and hence have potential application in the treatment of Osteoarthritis (OA). To evaluate the safety and efficacy of Curene® a randomized, double blind, placebo controlled, parallel-group study was conducted in subjects with knee OA. Significant improvements in clinical endpoints were observed during the trial along with excellent safety profile. Methods Fifty (50) subjects aged between 40 and 75 years who were suffering from unilateral or bilateral OA of the knee for greater than 3 months according to American College of Rheumatology (ACR) criteria were enrolled. They were randomized into two treatment groups; one group received Curene® 500 mg once daily and the other group received placebo. Efficacy was evaluated using change from baseline in Visual Analogue Scale (VAS) and Western Ontario and McMaster Universities Osteoarthritis Index (WOMAC) score. Biochemical and hematological parameters including urine analysis were performed to evaluate the safety of Curene® in OA patients. Result Forty-six (46) subjects completed the study. The reduction from baseline in total WOMAC score (also subscale scores) and VAS score resulted in statistically significant difference when compared to placebo. It was also found to be safe and well tolerated as there was no incidence of treatment related AEs. Conclusion Curene® results in statistically significant and clinically meaningful reduction in pain, stiffness, and improvement in physical functioning in subjects suffering from knee OA. Curene® also demonstrates excellent safety profile during the study. Trial Registration This trial is registered with Clinical Trial Registry, India, CTRI/2017/07/009044, registered on 14th July 2017, http://ctri.nic.in/Clinicaltrials/showallp.php?mid1=19264&EncHid=&userName=ocius%20life%20sciences.

No abstract

Background: Curcumin, a major active component of turmeric, which is one of the most studied botanicals for its numerous health benefits and higher safety profile. In spite of its potent clinical health benefits, its applications are circumscribed due to its poor bioavailability. The current study was carried out to compare the oral bioavailbility of newly developed bioavailable curcumin formulation Curene® with Curcumin formulation containing turmeric volatile oil (CP-01) and Standard Curcuminoids 95% in healthy human volunteers.Methods: In this current open-label, randomized, three treatments, single oral dose, single period, parallel, comparative pharmacokinetics study, 12 healthy male volunteers participated. The test product Curene® (T), reference products CP-01(Reference treatment-R1) and Standard Curcuminoids 95% (Reference treatment-R2) were orally administrated as a single dose of 3 grams per subject. Plasma samples were withdrawn from each subject at predetermined timepoints and samples were analyzed by LC-MS/MS. Results: Based on the pharmacokinetics data, the relative bioavailability (Free Curcumin; AUC0-t) of Curene® was found to be ~112.7 times more when compared to the standard Curcuminoids (R2).Conclusion: The oral bioavailability of Curene® was found to be significantly higher compared to CP-01and Standard Curcuminoids (95%) furthermore, it was also found to be safe in healthy human subjects under the study conditions.