You've got a product that enhances immune function, but today's consumers are burned out on the same old marketing campaigns and promises. They want proof. A clinical trial provides the evidence your brand needs to build consumer trust and keep the world healthier.
ENDPOINTS FOR IMMUNE HEALTH STUDIES
Finding the balance between making supplement claims such as "supports the immune system" and forbidden drug claims such as "prevents COVID-19" is easier said than done when it comes to clinical trials for natural products. To fully and accurately capture the benefits of natural immune support, you need the expertise of epidemiologists, the knowledge of aromatherapists, dietitians, or herbalists, and the proficiency of a clinical trialist.
Because of this complexity, many firms opt instead for treatment-focused trials, testing products on people who are already sick. This approach, however, can cause the FDA to reclassify your immune supporting product as a pharmaceutical, resulting in substantial costs both financially and opportunity.
So how do you prove that your aromatherapy blend, herbal supplement, or nutraceutical provides immune support for healthy people? Nutraceuticals Research Institute helps you meet this challenge with our proprietary Franklin Health Immune Status Scale (FHISS).
The FHISS is the first tool of its kind developed exclusively for the natural products industry to measure immune support in healthy individuals. This comprehensive measurement captures the accurate effects of immune support by focusing on a holistic understanding of the immune system as a whole. This tool enables our research team to document your product's effects on prevention, wellbeing, and susceptibility to disease in accordance with the regulatory guidelines for natural supplements.
A natural products immune support trial at Nutraceuticals Research Institute focuses on 6 primary endpoints, though your trial's endpoints will be hand-selected by our research team to match your product's greatest effects. Our standard immune health endpoints include:
Respiratory Symptoms
Documenting incidence, prevalence, and duration of respiratory symptoms confirms that product provides respiratory-focused immune support.
GI Symptoms
Documenting incidence, prevalence, and duration of GI symptoms confirms that product provides gastrointestinal-focused immune support.
Nonspecific Symptoms
Capturing general symptoms such as fever, muscle pain, or fatigue provides a clear overview of how well your product keeps people healthy.
Daily Function
Daily function scores indicate how well each participant is able to accomplish routine tasks thanks to a strong immune system.
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.
Questions about Immune Support Trials
YOU KNOW YOUR PRODUCT WORKS; WE'LL HELP YOU PROVE IT.
Schedule a free, no-obligation meeting with a scientist today to learn more about how Nutraceuticals Research Institute can help your product become "clinically proven."