Immune Support

Clinical trials for immune-supporting natural products

Over 90% of females report experiencing a combination of symptoms before or during their period. Products capable of reducing or eliminating these symptoms deliver improved quality of life, enhanced productivity, and higher quality emotional health, resulting in a substantial market for natural supplements. With more and more consumers expecting scientific substantiation for marketing promises made, clinical trials on PMS products are now a must.

Findings from a clinical trial unlock numerous new avenues for marketing, brand integrity, and even stability. These findings allow you to legally and ethically make marketing claims that your product improves menstrual health. They also supply the documentation required for FDA and FTC compliance.

ENDPOINTS FOR PMS RELIEVING STUDIES

PMS measurement has a rocky history. There is no lab test to quantify the severity of this natural process, and early attempts at psychometrics focused primarily on measuring ways in which other people were bothered by a menstruating woman's symptoms. To substantiate a PMS alleviating claim, you need endpoints that accurately and directly measure the target of your claim. Nutraceuticals Research Institute helps you achieve this with our proprietary Franklin Health Menstrual Symptom Scale (FH-MSS).

The FH-MSS was developed for women by female scientists and is the first tool of its kind to not only be created with the natural products industry in mind, but to represent a comprehensive and holistic view of PMS-related symptoms. This comprehensive symptom measurement is capable of capturing improvements to PMS regardless of which specific symptoms your product targets. It concentrates on the wide range of areas in which menstrual health can be improved and focuses on real world outcomes that matter to your consumers.

A natural products PMS trial at Nutraceuticals Research Institute will typically focus on 5 - 6 primary endpoints. Each product has unique needs, so your trial's specific endpoints will be determined through collaboration between your marketing goals and our research team, ensuring that they match your product's greatest effects. Our most commonly used endpoints include:

Menstrual Pain

Our pain scale was created for women by women and captures the unique ways in which women experience pain. This scale measures not only pain severity but also duration and frequency.

Cognition

For many women, PMS means brain fog. Poor concentration, struggling to remember things, and difficulty coming to decisions are all within the cognition realm of PMS symptoms.

Bloating

Gastrointestinal symptoms such as bloating, indigestion, gas, and other digestive complaints are common PMS symptoms and are targets of PMS-alleviating natural products.

Stress & Tension

The tension or stress subdomain refers to the extent to which a participant's demands exceed their ability to cope as a result of PMS.

Perspective

Perceived immune status indicates how well the participant believes their immune system is functioning.

Quality of Life

Documenting incidence, prevalence, and duration of dermal symptoms confirms that product provides skin-focused immune support.

Menstruation pad with red as blood drops all over the red background, women critical days, gynecological menstruation cycle.

High Angle View Of Young African Woman With Stomach Ache Lying On Sofa

Pattern with white menstrual cotton pads and tampons isolated on red background. Feminine hygiene products

Sport and life achievements and success concept. Rear view sporty girl raising arms towards beautiful glowing sunshine.

PMS CLINICAL TRIALS

Evaluating PMS-improving products can be complicated. Nutraceuticals Research Institute's extensive experience.

Working with Nutraceuticals Research Institute for a high-quality clinical trial with a PMS-related outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:

modulates mood changes associated with the menstrual cycle
reduces temporary water weight gain associated with the premenstrual cycle
alleviates menstrual cycle-induced cramps
for relief from edema and bloating associated with PMS
diminishes the effects of PMS

PMS is typically selected as a primary endpoint for a nutraceutical study. It can be enhanced by the addition of closely related secondary or tertiary endpoints such as mood, stress, or sleep, all of which are known to be influenced by PMS-related factors.

Most PMS trials last a minimum of 3 full menstrual cycles, which is typically 90-100 days. This allows ample time for baseline menstrual symptom data collection prior to capturing the effects of your product.

Questions about PMS Support Trials

Is the NRI PMS Scale validated?

We love talking about our proprietary suite of psychometric measurement instruments!

These tools were developed to far exceed recommendations in the FDA's guidance on the use of Patient Reported Outcome Measures (PROMs) for the substantiation of labeling claims. The scale contains a combination of subjective and objective data which are aggregated to produce total scores on each of the PMS-related subdomains.

Each of our measures are validated and norm-referenced in a population of healthy adult females. Our development priorities include elimination of floor or ceiling effects in this priority population as well as ensuring that each domain has highly precise sensitivity to change.

Our PMS scale was developed and pilot tested with focus groups and qualitative research to ensure face and content validity. They were then tested for psychometric properties using confirmatory factor analysis and item response. Internal reliability was determined via Cronbach's alpha.

Our PMS subscales have Cronbach's alpha scores ranging from .82 to .90, which is an ideal range for both exceeding minimum standards for internal reliability while avoiding redundancy and participant burden.

Confirmatory factor analysis confirmed that each subscale measures a single latent factor, with each subscale contributing to the broad latent factor of PMS symptoms. Factor loadings were all below 0.5, SRMRs were below 0.8, and coefficient of determinations were above 0.8.

In item response theory testing using graded response modeling, each item in the final version of the scale was found to be highly discriminating with IRT discrimination (trait) parameters all above 1.5 and over 50% of item trait parameters above 2.0. Difficulty parameters and test information curves identified that the test is most reliable within +/- 1.5 standard deviations of the mean.

Practically speaking, this means that the test is calibrated to identify PMS symptoms among an average American female adult population and is capable of identifying changes that go both above and below the norm. This ensures that our measures capture the totality of your product's effects on each subdomain of PMS.

How long does a PMS support trial take?

We create each and every trial around your product's key benefits. The intervention period is going to be the driving factor in the trial's total duration.

As a general rule, plan on 6-8 weeks from contract execution to the first participant's start date. This time is for protocol development and obtention of ethical authorizations/registrations. This is the most important timeframe of the entire study as it lays the groundwork for a trial that meets our high standards of quality and is capable of staying on the target timeline.

Following the first participant's start date, we typically recommend adding 2 months to the total intervention period for us to hand-select each participant in your study among our nationwide community of participants. This means that a 1-week intervention would require approximately 9 weeks for this phase, whereas a 3-month intervention would require approximately 5 months.

After all data are collected, our team audits each dataset to ensure accuracy. We then clean the data, construct the outcome variables from the data collected, and begin statistical analysis. This phase takes 4-6 weeks on average. More complex studies with multiple outcomes can take several months.

Once outcomes are confirmed, we immediately provide you a quick review of the findings. Our team then spends another 2-4 weeks creating a long-form technical report that goes into precise details of the entire study, a submission-ready scientific manuscript for publication of the findings, and a full color lookbook which contains the technical report contents as well as attention catching graphs and charts. This ensures that everyone on your team, from legal to scientific to marketing, has access to the findings in the form that best meets their needs.