Our core philosophy focuses on quality ahead of quantity when it comes to clinical trials. Our trial design and conduct helps in uncovering the TRUE efficacy and safety of our ingredients.
Numbers speak. But this is not always true when it comes to percentage improvements. If the improvements are tested using wrong scales, ingredient will fail to deliver efficacy despite big numbers.
In the male sexual health category, we come across number of ingredients like fenugreek, tongkatali, etc. that are clinically proven using unrelated scales like AMS and DSIF-SR. All Quality of Life (QoL) scales are validated for specific use. AMS (Aging Male Scale) for example is 17 point scale used to measure the severity of aging-symptoms and their impact on QoL related to androgen deficiency in males. It is not a validated scale and its correlation with testosterone is also controversial. It measures sex, libido, mood, sleep, physical and general well-being. Similarly, DSIF-SR (Derogatis Interview for Sexual Functioning) is 26 point scale, used by some researchers suffers from a low specificity and sensitivity. ENovate’s patented ingredient HeezOn® is clinically proven for its men’s health benefits using the highly valid and validated IIEF (International Index of Erectile Dysfunction) as against other popular ingredients tested using AMS or DSIF-SR. IIEF is 15 point scale used specifically for erectile dysfunction with high degree of sensitivity and specificity. It is a validated scale used in 50+ studies including Viagra. It measures erectile function, orgasm, ejaculatory control, intercourse and sexual satisfaction.
Ethics and conflicts of interest are important GCP considerations of any clinical trial planning and conduct. Ethical use of placebo or active control group in clinical trials is still debated. Placebo-controlled studies are perceived as the “gold standard” for proving efficacy. However, at times giving study volunteers a placebo may be considered unethical.
The two crucial principles in clinical research are to minimize bias and to increase precision. If a study is not designed and conducted with these two principles in mind, no amount of analysis will rectify a situation.
EnXtra® is clinically proven to improve alertness and focus. In the clinical study, alertness was tested using Jin Fan Attention Network Test (ANT) as primary efficacy variable. To increase precision and minimize bias, several finer trial aspects were planned and implemented during the study. Subjects were asked to be on site at consistent time throughout the study, as being late might hamper alertness naturally. To maintain acclimatization, subjects are provided same room during each visit. Similarly same laptops are used for each assessment to avoid confounding related to laptop processor speed. Subjects are advised to maintain dinner habits they had prior to every visit, to minimize effect of food on sleep and morning alertness. Several similar finer aspects of study conduct were implemented to increase the quality of clinical data.
Demonstrating statistically significant superiority over placebo is the goal of every supplement human study. But this can be challenging if one has to recruit only healthy volunteers in a study. Smaller differences versus placebo require larger sample size. ENovate study teams carefully balance between study costs and p values when estimating sample size and are super vigilant about limiting screening failures and dropouts of study participants.
Intention to treat means the data is analysed for all participants enrolled in the study regardless of dropouts and withdrawals. Some trials analyse the data using an on-treatment analysis where patients are only analysed if they received the treatment they were randomised to. An intention to treat analysis preserves the randomisation process. It also takes care of unexpected adverse events (trial participant cannot dropout of the trial analysis if they have an adverse effect of treatment) and is less open to fraud (the trialists cannot exclude any subjects who did not achieve the hoped-for outcome).
Clinical trials must report on their outcomes, irrespective of results. This is part of ENovate ethical trial conduct policy. All ENovate clinical trials are registered on ClinicalTrials.gov to ensure that there is no deviation in protocol and results reported.
In HeezOn® published clinical trial, study reported insignificant decrease in testosterone at the end the 60 days period, despite literature data supports HeezOn® ingredients to boost testosterone. Also in unpublished exploratory clinical study on 9 patients, reported 6.9% increase in Serum testosterone levels. As inferred in the paper, the changes observed in the treatment groups may be a result of the naturally occurring variations in testosterone levels. Many studies have well documented diurnal, seasonal and intra individual variation of testosterone levels in men i.e. in the same subject, the testosterone levels might considerably vary with the different phase of day and also testosterone levels in two different subjects might show different pattern of this change. Brambilla et al. showed that “biological” intra-individual variation in T levels of approximately 10% is observed when samples are collected from the same individual at the same time of the day over several days. Moreover certain food habits and medication might also affect testosterone levels. Factual outcomes are reported in published study.
Although hugely popular, Withania somnifera is often contaminated with related species Withania coagulans. Withania coagulans is also important plant for its property of coagulating milk. To ensure the best male sexual health benefits HeezOn® uses only DNA authenticated roots of Withania somnifera. DNA finger printing of Withania somnifera roots.
Out of several species of Alpinia, three most commonly grown species are Alpinia galanga, Alpinia calcarata and Alpinia officinarum. The roots of Alpinia galanga and Alpinia officinarum are well identified in trade as greater and lesser galangal respectively. But the roots of Alpinia galanga and Alpinia calcarata appear very similar to the untrained eye and hence any adulteration or substitution can go unnoticed. Because of the close similarities between Alpinia calcarata and Alpinia galanga, a macroscopy, microscopy and DNA testing together helped authenticate EnXtra® raw material.
