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KMID : 1161420200230091006
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Journal of Medicinal Food
2020 Volume.23 No. 9 p.1006 ~ p.1013
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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
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Panda Sanjib Kumar
Nirvanashetty Somashekara
Parachur Vivek A.
Mohanty Nilima
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Abstract
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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.
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KEYWORD
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herbal treatment options, IELT, OLNP-05, PEP, premature ejaculation
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