Relaxation 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, Cardiac dysfunction, others

Compensation: Varies

Number of Visits: Unknown

Duration: 7 weeks

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial tests whether certain relaxation products can reduce stress and improve health. Participants will receive one of two different active relaxation products or a placebo (a product with no active ingredients). The trial aims to determine if these products can make life less stressful and healthier. Ideal participants are U.S. residents who believe they could see at least a 30% improvement in their stress levels. As an unphased trial, this study offers participants the chance to contribute to groundbreaking research that could enhance stress management solutions.

Will I have to stop taking my current medications?

The trial requires that you do not take medications that have a known moderate or severe interaction with the study products, such as blood thinners, blood pressure medications, and certain mental health medications. If you are on any of these, you may need to stop them to participate.

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

Research is examining how Relaxation Active Products 1 and 2 might affect stress. Previous studies have shown that some health and wellness products can influence stress levels. However, specific safety information for these products is not yet available.

Without detailed safety data, determining how well people might tolerate these products is challenging. The trial is marked as "Not Applicable" for its phase, indicating that the safety information might be incomplete. Prospective participants should discuss any concerns with the trial organizers to understand possible risks. ^{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 typical stress-relief methods like medication or therapy, these products utilize innovative formulations that may provide a more natural and accessible alternative. Relaxation Active Product 1 and 2 are designed to potentially offer relief without the common side effects associated with conventional treatments. This new approach could be a game-changer for people seeking effective stress management with minimal intervention.

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

This trial will compare Relaxation Active Product 1 and Relaxation Active Product 2 with a placebo control. Studies have shown that relaxation techniques can help reduce stress, anxiety, and depression to some extent. Mindfulness and relaxation methods, like those used in Relaxation Active Product 1, have effectively changed cortisol levels, a hormone related to stress. Research also shows that using relaxation tools for 1-6 weeks can significantly decrease stress symptoms.

For Relaxation Active Product 2, studies indicate that breathing exercises can greatly lower stress levels. Techniques like progressive muscle relaxation, deep breathing, and guided imagery, similar to those in this product, have helped participants feel more relaxed. These methods have effectively managed stress by changing cortisol levels in healthy adults. ^{6 7 8 9 10}

Who Is on the Research Team?

Susan Hewlings

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 feel stressed and believe they can improve their health by at least 30%. Participants must be willing to take a product without knowing if it's active or placebo. All ethnicities, races, and gender identities are welcome.

Inclusion Criteria

I live in the United States.

I am 21 years or older and understand my participation includes sex-specific aspects.

I am open to possibly improving my health by 30% and okay with not knowing if I'm receiving the actual treatment or a placebo.

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive the study product or placebo and report health indicators electronically

7 weeks

All assessments are electronic; no in-person visits

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Relaxation Active Product 1
• Relaxation Active Product 2
• Relaxation Placebo Control

Trial Overview The study is testing two different 'Radicle Relaxation' products against a placebo to see which one better reduces stress and improves related health outcomes. It's randomized and double-blind, meaning neither participants nor researchers know who gets what until the end.

How Is the Trial Designed?

Group I: Active Product 2 Experimental Treatment 1 Intervention

Relaxation Product Form - Active 2

Group II: Active Product 1 Experimental Treatment 1 Intervention

Relaxation Product Form - Active 1

Group III: Placebo Control Placebo Group 1 Intervention

Relaxation Product Form - Control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06378801

Radicle Relaxation 24: A Study of Health and Wellness ... Endorses less stress as a primary desire; Has the opportunity for at least 20% improvement in their primary health outcome; Expresses a willingness to take a ...

2. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC9238062/

Effectiveness of relaxation techniques 'as an active ingredient ... The results of meta-analysis showed that relaxation techniques work across three outcomes (distress, anxiety and depression) yielding small to moderate effect ...

3. sciencedirect.com sciencedirect.com/science/article/pii/S0306453023003931

Effectiveness of stress management interventions to ... Mindfulness and relaxation interventions were most effective at changing cortisol levels. •. Interventions were more effective at changing cortisol awakening ...

4. researchgate.net researchgate.net/publication/396943918_A_Review_of_the_Effectiveness_of_Three_Main_Types_of_Stress-Reduction_Products

(PDF) A Review of the Effectiveness of Three Main Types ... This study aims to examine how different products' effectiveness varies by demographic factors through three selected product categories that ...

5. formative.jmir.org formative.jmir.org/2024/1/e50506

Association of Digital Engagement With Relaxation Tools and ... Results: Analysis revealed a significant decrease in stress symptoms (β=–.25; 95% CI –0.32 to –0.17; P<.001) during the period of 1-6 weeks of ...

6. ctv.veeva.com ctv.veeva.com/study/radicle-relaxation-24_vns-a-study-assessing-the-impact-of-health-and-wellness-products-on-stress-a

Radicle Relaxation™ 24_VNS: A Study Assessing the Impact ... Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with ...

7. meddatax.com meddatax.com/clinical-trials/NCT06378801

Radicle Relaxation 24: A Study of Health and Wellness Products on ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes.

8. ctv.veeva.com ctv.veeva.com/study/radicle-relaxation-24-a-study-of-health-and-wellness-products-on-stress-and-related-health-outcomes

Radicle Relaxation 24: A Study of Health and Wellness ... A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes.

9. sigma.larvol.com sigma.larvol.com/facility.php?FacilityId=199518

Clearview Cancer Institute Trials ... Products on Stress and Related Health Outcomes. Active, not recruiting. N/A. 1702. US. Placebo Control Form 1, Relaxation Active Study Product 1.1, Placebo ...

10. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC8475422/

A Randomized, Triple-Blind, Placebo-Controlled, Crossover ... These data suggest that AlphaWave® l-Theanine reduced stress when moderately stressed but otherwise healthy adults were facing an acute stressor ...