A Randomized, Double Blind, Placebo Controlled, Parallel-Group Study to Evaluate the Safety and Efficacy of Curene® versus Placebo in Reducing Symptoms of Knee OA

Abstract

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.

Therapeutic effects of turmeric or curcumin extract on pain and function for individuals with knee osteoarthritis: a systematic review

“…Of the 10 RCT’s one did not provide gender data. 26 The remaining nine studies included 1237 participants, 340 men and 897 women. The mean age across the 10 studies was 56.85±9.19 years.…”

“…Of six studies comparing turmeric to placebo, five documented rescue therapy with NSAIDs or acetaminophen. 26–28 31 32 These five studies tracked the use of rescue therapy throughout their respected studies and reported an overall reduction in the use of rescue therapy in the turmeric group over placebo. Two studies compared turmeric to NSAID therapy for which rescue medication was not used.…”

Clusters of Responders and Predictive Factors for Response to Supplementation With Boswellia, Turmeric, and Red Algae Extracts in Painful Knee Osteoarthritis: A Prospective Observational Study Using an Arsenal of Patient Centred-measures

“…The ability of boswellia (Boswellia serrata) and turmeric (Curcuma longa) extracts (alone or in combination) to relieve patients with KOA has been largely described in the literature [9][10][11][12][13][14][15][16][17][18][19][20]. However, to the best of our knowledge, this is the rst and unique study reporting data where their combination with red algae extracts is used.…”

“…Most studies evaluating treatment effect in KOA usually focused on pain intensity and physical function [9][10][11][12][13][14][15][16][17][18][19][20]. In these studies, pain intensity was commonly assessed using a VAS and physical function using the Western Ontario McMaster Arthritis Index (WOMAC), a self-administered 24-item questionnaire [10,12,13,[15][16][17]20]. The WOMAC assessed activities of daily living, functional mobility, gait, general health and quality of life.…”

“…Traditional medicines using natural derived compounds may offer this safe alternative [3]. Numerous studies, including several randomised clinical trials versus placebo or NSAIDs, have shown that boswellia (Boswellia serrata) and turmeric (Curcuma longa) extracts (alone or in combination) may relieve patients [9][10][11][12][13][14][15][16][17][18][19][20]. Their e cacy was supported by the presence of active ingredients with anti-in ammatory and/or antinociceptive properties such as boswellic acids [21][22][23] or curcumin [3,24,25].…”