Clinical trials for immune-supporting natural products
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? Franklin Health Research 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 Franklin Health 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:
Capturing general symptoms such as fever, muscle pain, or fatigue provides a clear overview of how well your product keeps people healthy.
Daily function scores indicate how well each participant is able to accomplish routine tasks thanks to a strong immune system.
Perceived immune status indicates how well the participant believes their immune system is functioning.
Documenting incidence, prevalence, and duration of respiratory symptoms confirms that product provides respiratory-focused immune support.
Documenting incidence, prevalence, and duration of GI symptoms confirms that product provides gastrointestinal-focused immune support.
Quality of Life
Documenting incidence, prevalence, and duration of dermal symptoms confirms that product provides skin-focused immune support.
Immune Health Clinical Trials
Capturing benefits to immune health involves monitoring health status on a daily basis for an extended period of time. Our team is specialized at this high level of participant monitoring to capture each and every symptom, leading to a larger effect size for your product.
Working with Franklin for a high quality clinical trial with a immune-supportive outcome is a worthwhile investment as these studies have the potential to substantiate claims such as:
- supports the immune system
- improves immune health
- protects immune health
- boosts healthy immune function
- delivers immune support
Immune health is typically selected as a primary endpoint for a nutraceutical study. Studies evaluating immune support can also be enhanced by adding outcomes such as sleep and stress.
Questions About Immune-Support Trials
You know your product supports immune health; we'll help you prove it.
Schedule a free, no-obligation meeting with a scientist today to learn more about how Franklin can help your product become "clinically proven."