Wellness Products for Stress

Overseen By Study Manager

Age: 18+

Sex: Any

Trial Phase: Academic

Sponsor: Radicle Science

Must not be taking: Anticoagulants, Antidepressants, Antipsychotics, others

Disqualifiers: Pregnancy, Heavy drinking, Major illness, others

Compensation: Varies

Number of Visits: Unknown

Duration: 6 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to evaluate how different health and wellness products might reduce stress and improve related health outcomes. Participants will receive either a relaxation product or a placebo (a harmless, inactive substance) to compare effects. Those who often feel stressed and wish to explore new management methods may be suitable, provided they do not have serious health issues or take certain medications. Participants must reside in the U.S. and be willing to try a treatment without knowing if it is active or a placebo. As an unphased trial, this study offers a unique opportunity to explore innovative stress management solutions.

Will I have to stop taking my current medications?

The trial requires that you stop taking certain medications that could interact with the study products. These include blood thinners, blood pressure medications, anxiety and depression medications, and others. If you're on any of these, you might need to stop them to participate.

Is there any evidence suggesting that this trial's treatments are likely to be safe?

Research shows that relaxation techniques are generally safe and easy to manage. For Relaxation Active Study Product 1.1, studies have found that methods like meditation and yoga effectively manage stress without major side effects. These techniques help calm the mind and body, which most people find manageable.

For Relaxation Product Form 2, a study indicated that relaxation methods for stress relief are safe and usually do not cause serious problems. These methods often include breathing exercises and meditation, which are gentle on the body.

Research on Relaxation Product Form 3 also confirms its safety. Evaluations of relaxation techniques used in this product have not shown significant negative effects. These methods aim to relieve stress in a non-invasive way.

Finally, studies support Relaxation Product Form 4, highlighting its safe use for stress management. These studies, which examine various relaxation methods, suggest they are generally safe and effectively reduce stress. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about these relaxation products because they offer a fresh approach to managing stress. Unlike traditional stress treatments that often rely on medications or therapy, these products use active ingredients specifically designed to promote relaxation through potentially novel mechanisms. Additionally, the variety of formulations being tested might provide more personalized options for individuals, catering to different needs and preferences. This innovative approach could lead to faster and more effective stress relief compared to existing methods.

What evidence suggests that this trial's treatments could be effective for stress?

Research shows that stress management and relaxation techniques effectively reduce stress. Studies have found that these methods lower cortisol levels, a hormone that rises during stress. They also help reduce blood pressure and improve emotional well-being. In this trial, participants will receive various relaxation products, such as Relaxation Active Study Product 1.1 and Forms 2, 3, and 4, based on these techniques. This suggests they might offer similar benefits. Specifically, digital relaxation tools, like breathing exercises, have reduced stress over time. This evidence suggests that these relaxation products may effectively manage stress. ^{6 7 8 9 10}

Who Is on the Research Team?

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science Inc.

Are You a Good Fit for This Trial?

This trial is for adults over 21 in the U.S. who want to reduce stress and can improve their health by at least 20%. Participants must be willing to take an unknown product (active or placebo) and have internet access. Excluded are those with major recent illnesses, heavy drinkers, pregnant women, people with certain heart, liver or kidney diseases, or those on medications that interact with the study products.

Inclusion Criteria

I want to reduce my stress levels.

Has the opportunity for at least 20% improvement in their primary health outcome

Resides in the United States

Exclusion Criteria

I've had a major illness or surgery in the last 3 months that could affect my safety.

Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day)

Unable to read and understand English

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

1-2 weeks

Baseline

Collection of baseline self-reported data electronically

1 week

Treatment

Participants receive the study product or placebo for stress reduction

6 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

1 week

What Are the Treatments Tested in This Trial?

Interventions

• Placebo Control Form 1
• Relaxation Active Study Product 1.1

Trial Overview

The study compares a relaxation active product against a placebo to see if it reduces stress and improves related health outcomes. It's randomized (participants are put into groups by chance), double-blind (neither researchers nor participants know who gets what treatment), and placebo-controlled.

How Is the Trial Designed?

Group I: Active Product 4.2 Experimental Treatment 1 Intervention

Relaxation Product Form 4 - active product 2

Group II: Active Product 4.1 Experimental Treatment 1 Intervention

Relaxation Product Form 4 - active product 1

Group III: Active Product 3.1 Experimental Treatment 1 Intervention

Relaxation Product Form 3 - active product 1

Group IV: Active Product 2.1 Experimental Treatment 1 Intervention

Relaxation Product Form 2 - active product 1

Group V: Active Product 1.1 Experimental Treatment 1 Intervention

Relaxation Product Form 1 - active product 1

Group VI: Placebo Control 2 Placebo Group 1 Intervention

Relaxation Product Form 2 - control

Group VII: Placebo Control 1 Placebo Group 1 Intervention

Relaxation Product Form 1 - control

Group VIII: Placebo Control 3 Placebo Group 1 Intervention

Relaxation Product Form 3 - control

Group IX: Placebo Control 4 Placebo Group 1 Intervention

Relaxation Product Form 4 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Published Research Related to This Trial

The placebo effect can significantly relieve pain and improve affective disorders, indicating that inert medications can have real therapeutic benefits for patients.

Despite its potential, the placebo effect is often underutilized in clinical practice and inadequately assessed in clinical trials, highlighting the need for greater recognition and understanding of its mechanisms and impact.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

A guide to the pharmacology of placebos. Gowdey, CW.[2022]

A systematic review of 234 randomized placebo trials involving 10,525 patients found that placebo interventions generally do not have clinically important effects across various health conditions, with a pooled effect size indicating minimal benefit.

However, placebo interventions showed some influence on patient-reported outcomes, particularly for pain and nausea, although the effects varied widely and were often difficult to separate from reporting biases.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. Hróbjartsson, A., Gøtzsche, PC.[2022]

In a randomized trial with 20 individuals with spinal cord injury, high-frequency repetitive transcranial magnetic stimulation (rTMS) showed significant improvements in lower limb muscle strength, particularly in total leg and knee flexor/extensor strength, compared to sham stimulation.

While rTMS improved the lower extremity motor score (LEMS) at discharge, it did not significantly enhance gait function, suggesting that rTMS may aid muscle strength recovery but has a limited effect on gait performance in the short term.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Effects of repetitive transcranial magnetic stimulation on recovery in lower limb muscle strength and gait function following spinal cord injury: a randomized controlled trial. Krogh, S., Aagaard, P., Jønsson, AB., et al.[2022]

The study systematically analyzed placebo effects from randomized, placebo-controlled trials, revealing that while placebos can influence clinical symptoms, they do not affect laboratory values like blood glucose in diabetics.

Placebo side effects were found to be similar to those of active treatments, highlighting the importance of careful placebo use in clinical research to ensure patient safety and informed consent.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

Placebo treatment is effective differently in different diseases--but is it also harmless? A brief synopsis. Weihrauch, TR.[2019]

A new checklist called TIDieR-Placebo has been developed to improve the reporting of placebo or sham interventions in clinical trials, ensuring that researchers clearly describe these components alongside active treatments.

The checklist was created through expert consultation and aims to enhance the transparency of trial results, which is crucial for accurately assessing the benefits and harms of active interventions.

NCBI (Pubmed)

pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. Howick, J., Webster, RK., Rees, JL., et al.[2020]

Citations

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pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC12164322/

Effectiveness of stress management and relaxation ...

To assess whether relaxation and stress management techniques are useful in reducing blood pressure in individuals with hypertension and prehypertension.

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sciencedirect.com

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Effectiveness of stress management interventions to ...

Meta-analytic evidence suggests stress management interventions are effective in changing cortisol levels in healthy adults.

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frontiersin.org

frontiersin.org/journals/psychology/articles/10.3389/fpsyg.2024.1347336/full

Exploring the sustained impact of the Mindfulness-Based ...

The MBSR program appears to be most effective in reducing stress levels shortly after completion. Participants reported immediate benefits in ...

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pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40519356/

Effectiveness of stress management and relaxation ...

The results of the study indicated that relaxation and stress management techniques might have beneficial short term effects on blood pressure for people with ...

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researchgate.net

researchgate.net/publication/375334731_Effectiveness_of_stress_management_interventions_to_change_cortisol_levels_a_systematic_review_and_meta-analysis

(PDF) Effectiveness of stress management interventions to ...

A study by Rogerson et al. found that mindfulness and relaxation interventions were most effective in changing cortisol levels (13) . Patients ...

6.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC10175042/

Individual‐level interventions for reducing occupational ...

Individual interventions include focusing on stress (e.g., CBT), away from stress (e.g., yoga), or altering work demands. These may reduce stress up to a year.

7.

pmc.ncbi.nlm.nih.gov

pmc.ncbi.nlm.nih.gov/articles/PMC7349817/

How to Relax in Stressful Situations: A Smart ...

This paper describes emotion regulation in the context of stress management and how yoga and mindfulness can be used for regulating emotions (Section 2).

8.

researchgate.net

researchgate.net/publication/286050974_Stress_relief_The_role_of_exercise_in_stress_management

Stress relief: The role of exercise in stress management

Exercise can be an effective component of a stress management program, and all types of exercise can be beneficial for stress management.

9.

researchgate.net

researchgate.net/publication/260194229_Effectiveness_of_a_Comprehensive_Stress_Management_Program_to_Reduce_Work-Related_Stress_in_a_Medium-Sized_Enterprise

Effectiveness of a Comprehensive Stress Management ...

We concluded that the comprehensive stress management program was effective in reducing work-related stress in a short-term period.

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jamanetwork.com

jamanetwork.com/journals/jamanetworkopen/fullarticle/2796494

Efficacy of Transcendental Meditation to Reduce Stress ...

This randomized clinical trial assesses the efficacy of Transcendental Meditation practice over a 3-month period for the reduction of stress ...