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A Double-Blind, Placebo Controlled Trial, Evaluating the Effects of a Proprietary Blend of Plant Adaptogens on Sexual Satisfaction and Sexual Response in Adult Males

: Introduction : Adaptogens are plant substances that offer resistance of the organism to stressors. The human genome is able to utilize these plant derived substance to increase cellular defense in-vivo. Previous studies which validated adaptogens benefit in athletic training and performance also demonstrated subjective reports of improved male sexual performance. It is the objective of this trial is to isolate and report the human male sexual response to a proprietary blend of adaptogens, androgenic herbs combined and select amino acids (Admax®/Potenter®) and compare it to placebo, over a 14 day period when compared to placebo. Methods : Subjects were randomized into two cohorts to compare study compound (n=42) with placebo (n=21). Exclusion criteria eliminated individuals with organic impotence and organic heart disease as well as those unable to give informed consent or unable to adhere to study protocol. Participants completed the International Index of Erectile Function (IIEF) prior to dosing and instructed to attempt sexual intercourse a minimum of twice per week during the study period. They also were instructed to complete a sexual satisfaction diary, which became part of the source documents upon completion of the trial. Each participant was provided 50 capsules of either study compound or placebo (8 capsules per day with 2 additional capsules). Participants completed the IIEF upon completion of the study as well. Results : 63 healthy adult males (age range 30-58, mean = 42.4, ± 3), were consented and enrolled in a placebo controlled, double blind, study of the male sexual experience and satisfaction in response to a proprietary blend of adaptogens (Admax/Potenter®). All participants completed the trial and submitted both pre & post self assessment utilizing the International Index of Erectile Function (IIEF). Participants on study compound (n=42) improved in all 5 measured parameters, compared to no change in the placebo group (n=21). All data was validated utilizing 2-tailed Student – T. Erectile function improved from 11.5 to 22.7 (p (cid:1) 0.04) compared to placebo (decreased from11.7 to 10.8). Intercourse satisfaction improved from 5.6 to 11.1 (p (cid:1) 0.05) compared to placebo (decreased from 5.5 to 5.2). Orgasmic function improved from 4.6 to 8.7 (p (cid:1) 0.05) compared to placebo (increased from 4.7 to 4.8, not statistically significant). Sexual desire improved from 5.4 to 8.6 (p (cid:1) 0.1) compared to placebo (decreased from 5.3 to 5.2). Overall sexual satisfaction improved from 3.1 to 9.1 (p (cid:1) 0.01) compared to placebo (decreased from 3.3 to 2.9). Discussion : This data demonstrates that the male sexual experience is markedly enhanced with the utilization of this adaptogenic compound (Admax®/Potenter®), when taken 3-6 hours prior to anticipation of sexual intercourse. Subjectively, the data would also indicate that the effect is relatively short acting (lasting 6-24 hours) and moderate onset of action (taken 3-6 hours prior to event). Pharmacokinetic studies were not performed. There were no side effects reported by any of the participants as is consistent with its use in previous clinical trials. All early indications would suggests, that this proprietary blend of adaptogens is an excellent supplement to increase the male sexual experience and can safely be used up to 14 days without demonstrated side effects.


INTRODUCTION
Adaptogens, (also known as phytoadaptogens) are defined as substances of plant origin that are able to increase a nonspecific resistance of the organism to stress factors and thereby promote its adaptation to stressful external conditions [1]. The human body has the ability to convert these plant derived substances to be utilized by our metabolic pathways to act in a similar cellular defense mechanism [2]. Biologically we are constantly under a condition of stress and certain amounts of stressors are not only normal but necessary. In fact, without stress, growth and development would be impaired. However, there are *Address correspondence to this author at the Metabolic and Genetic Research Institute, Largo, Florida, USA; Tel: 614-946-3588; E-mail: ifmresearch@aol.com many situations where stress is greater than the norm and if left unchecked, it can cause illness, injury or death. In everyday language, the term "stress" usually means an adverse reaction to some sort of unpleasant situation or danger. These stressors adversely affect physiologic sexual performance and function as well as psychological processes involved in sexual pleasure. Impairment of blood flow to the sexual organs combined with decreased erectile function negatively impacts the male sexual milieu.
It is postulated that a compound, such as found in adaptogens, that has improved the body's response to stressors as well as improved blood flow [3], will also improve the male sexual response. In previous clinical trials, utilizing the 4 primary adaptogens (Leuzea carthamoides, Rhodiola rosea, Eleutherococcus senticosus & Schizandra chinensis) in the performance of athletes, there were also subjective reports of improved male sexual performance and overall satisfaction with the sexual experience. The effects on sexual performance of Tribulus terrestris extract [4], Lepidium meyenii extract [5] and Eurycoma longifolia extract [6] have been previously studied and reported. In a study with mice, T. terrestris was shown to enhance mounting activity and erection better than testosterone cypionate [4]. The proerectile aphrodisiac properties were concluded to likely be due to the release of nitric oxide [7] from the nerve endings innervating the corpus cavernosum penis. Cormio [8], et al. demonstrated that L-Citrulline supplementation, which stimulates endothelial nitric oxide, can offer short term erectile hardness when compared to placebo. Likewise the role of L-arginine in the production and release of endothelial nitric oxide has been documented in the literature; however, it is only effective in individuals who have diminished nitric oxide due to cardiovascular disease [9]. The primary benefit of Larginine is its conversion in the liver via Cyto-P450-sC3 enzymatic action into Citrulline and nitric oxide [10].

Objective
It is the objective of this trial is to isolate and report the human male sexual response to this proprietary blend of adaptogens, androgenic herbs combined with select amino acids and compare it to placebo, over a 14 day period when compared to placebo.

METHODS
Enrollment in the study required that all subjects were male adults, between the age 30 and 60 and met the following inclusion criteria: • Able to offer informed consent, legally and cognitively Following verification of enrollees and affirmation of medical clearance from their PCP, each participant received either 50 capsules of study compound or placebo, randomized into 2 cohorts. One group of 42 males received active compound and a second group of 21 received placebo. Both participant and research coordinator were blinded during both the randomization and participation phases of the study. Un-blinding occurred only after data was gathered. Participants completed the International Index of Erectile Function (IIEF) [11] [see APPENDIX, RC Rosen, et al.], prior to dosing and instructed to attempt sexual intercourse a minimum of twice per week during the study period. The survey is designed to evaluate 5 key elements of the male sexual experience: 1) Erectile function, 2) Satisfaction with intercourse, 3) Orgasmic Function, 4) Sexual desire and 5) Overall satisfaction with the sexual experience. They also were instructed to complete a sexual satisfaction diary, which became part of the source documents upon completion of the trial. All participants were asked to take 8 capsules, daily for seven days, approximately 3-6 hours prior to sexual activity. Data was collected for a total of 14 days to determine approximate duration of action. Participants completed the IIEF upon completion of the study as well.
All data was collected and the study was closed, at which time the study compounds were un-blinded and statistical analysis of results was initiated.
Note: Although, neither recruited nor excluded, there were no known transgender participants enrolled in the study.

RESULTS & STATISTICAL ANALYSIS
POPULATION: 63 healthy adult males (age range 30-58, mean = 42.4, ± 3), were consented and enrolled in a placebo controlled, double blind, study of the male sexual experience and satisfaction in response to a proprietary blend of adaptogens (Admax/Potenter® [12]). All participants completed the trial and submitted both pre & post self assessment utilizing the International Index of Erectile Function (IIEF). Participants on study compound (n=42) improved in all 5 measured parameters, compared to no change in the placebo group (n=21). All data was validated utilizing 2tailed Student -T. Erectile function improved from 11.5 to 22.7 (p 0.04) compared to placebo (decreased from11.7 to 10.8). Intercourse satisfaction improved from 5.6 to 11.1 (p 0.05) compared to placebo (decreased from 5.5 to 5.2). Orgasmic function improved from 4.6 to 8.7 (p 0.05) compared to placebo (increased from 4.7 to 4.8, not statistically significant). Sexual desire improved from 5.4 to 8.6 (p 0.1) compared to placebo (decreased from 5.3 to 5.2). Overall sexual satisfaction improved from 3.1 to 9.1 (p 0.01) compared to placebo (decreased from 3.3 to 2.9). Table 1 below illustrates these findings.

DISCUSSION
The participants in this scientific assessment where offered a proprietary blend of adaptogens, androgenic herbs and amino acids for the purpose of evaluating the male sexual response. Participants given placebo demonstrated no response in any of the 5 elements of the survey tool. In contrast, the recipients of the study compound had vastly favorable responses. All recipients of the study compound experienced greater ability to obtain and maintain an erection, they were far more capable of achieving orgasm and intercourse was a more satisfying event when compared to their baseline satisfaction ratings. Their overall satisfaction with the sexual experience demonstrated the most remarkable improvement with the relative value score increasing 193.5%.
This data demonstrates that the male sexual experience is markedly enhanced with the utilization of this compound (Admax®/Potenter®), when taken 3-6 hours prior to anticipation of sexual intercourse. Subjectively, the data would also indicate that the effect is relatively short acting, lasting 6-12 hours (mean = 7.5 hrs ± 2.5 hrs.) and moderate onset of action (taken 3-6 hours prior to event). Pharmacokinetic studies were not performed. There were no side effects reported by any of the participants as is consistent with its use in previous clinical trials. All early indications would suggests, that this proprietary blend of adaptogens is