With an impact on 20% to 30% of the male population, premature ejaculation is one of men’s top sexual complaints. And given many men’s reluctance to admit sexual problems, the prevalence may be even greater.
A new five-ingredient botanical formula seeks to change that statistic. Fortiquin (OLNP-05), marketed by DolCas Biotech, is a standardized blend of extracts of mucuna seed, fenugreek seed, artichoke leaf, and ashwagandha root, alongside the amino acid L-arginine. DolCas said the product works by nourishing the nervous and hormonal systems as well as fortifying the stress response as it supports healthy sexual endurance and control in men.
“DolCas Biotech describes its concept of formulation as ‘informed by the wisdom of traditional practices such as Ayurveda, Traditional Chinese Medicine’, among other natural healing practices around the world – which have always held in high-esteem multi-botanical versus single ingredient approaches,” explained Shavon Jackson-Michel, ND, Director of Medical & Scientific Affairs for DolCas.
“The individual herbs in Fortiquin exist as extracts – not powders – delivering an enriched profile of the phytochemicals most associated with the herbs’ activity and organ affinity,” added Jackson-Michel.
While natural products are widely regarded for their anecdotal benefits for sexual issues, science-backed studies are often limited in their scope. To gain a better understanding of the issue at hand, researchers compared the efficacy and safety of OLNP-05 versus placebo for treating subjects suffering from premature ejaculation (PE).
The study
In this randomized clinical study, 60 men with PE were enrolled and randomly assigned to receive either OLNP-05 or a placebo capsule twice daily for 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 all used to assess the efficacy of treatment.
Findings
The findings show a 5.1-fold benefit over a placebo in safely supporting healthy sexual endurance and stamina among healthy male subjects over the 8-week course.
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 in the ‘much improved’ category as per the CGI-I assessment.
The authors concluded, “This study found that OLNP-05 is more effective than the placebo in prolongation of IELT, improving in individual parameters of PE score and improvement in CGI. No side effect was reported during the study. Thus, OLNP-05 may be considered as an appropriate alternative natural therapeutic option for the management PE.”
Safety
The comprehensive standardization of the formula includes 1.5% flavonoids and 20% saponins, as well as a patented trademark formulation to ensure consistency. The safety of Fortiquin (OLNP-05) in the clinical study was assessed by physical examination, vital signs, and monitoring for adverse events or changes to lab parameters. According to the study, there were no statistically significant differences in the number of adverse events and no remarkable changes in laboratory parameters, including red and white blood cell assessment, liver and kidney function. All vital signs were unaltered throughout the study.
“The synergistic blend retains an exclusive fingerprint for standardization, protecting the inventiveness of the brand, while at the same time complying with highest quality standards for consistency and traceability,” noted Jackson-Michel.
Source: Journal of Medicinal Food
Vol 23 Issue 9: September 2, 2020 doi.org/10.1089/jmf.2019.4661
“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”
Authors: S. Panda et al.