A Randomized Double-Blind Placebo-Control Study to Assess the Efficacy and Safety of OLNP-05 Versus Placebo for the Treatment of Subjects with Premature Ejaculation.

Premature ejaculation (PE) is one of the foremost sex-related health problems among men. The global occurrence ranges from 20% to 30%, according to various studies. PE has a great impact on the men's quality of life, with deleterious effects such as embarrassment, frustration, and feeling of incompetence. Considering the necessity of treatment of PE, this study was planned to compare the efficacy and safety of OLNP-05 versus placebo for treating subjects suffering from PE. In this randomized clinical study, 60 men with PE were enrolled and randomly assigned to receive either OLNP-05 or placebo one capsule twice daily for a period of 8 weeks. Subjects were evaluated during visits on day 1, day 28, and day 56. Mean change from baseline in intravaginal ejaculatory latency time (IELT), improvement in premature ejaculation profile (PEP), and Clinical Global Impression-Improvement scale (CGI-I) were used to assess the efficacy of treatment. P-value <.05 was considered significant. At the end of the treatment, the improvement in IELT score in the OLNP-05 group was remarkably higher than the placebo. Subjects in the OLNP-05 treatment group also reported significantly greater improvement in PEP subscale score. Majority of OLNP-05-treated subjects were found to be in the "much improved" category as per CGI-I assessment. The result confirms the safety and efficacy of OLNP-05, therefore suggesting that OLNP-05 may be a safe and effective intervention for the management of PE. Trial registration: Clinical Trials Registry India (Registration No: CTRI/2017/08/009226, 02/08/2017).

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.

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.