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

1702 Participants Needed

Trial Summary

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.

What data supports the effectiveness of the treatment Wellness Products for Stress?

The research suggests that placebos can relieve symptoms like pain and affective disorders (emotional conditions) by influencing patients' perceptions, which might indicate potential benefits for stress relief as well. ^{1 2 3 4 5}

Is the treatment generally safe for humans?

The safety of placebo or sham treatments, which are often used as controls in clinical trials, is generally considered low risk, especially for noninvasive treatments like oral medications. However, sham procedures can sometimes involve discomfort or risk, particularly in trials involving devices or invasive procedures. ^{1 6 7 8 9}

How does the placebo control treatment for stress differ from other treatments?

This placebo control treatment is unique because it involves an open-label placebo (a placebo given with full knowledge that it is a placebo), which has shown promise in reducing stress and improving well-being without the need for deception, unlike traditional placebos. ^{10 11 12 13 14}

What is the purpose of this trial?

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on stress and related health outcomes

Research Team

Emily K. Pauli, PharmD

Principal Investigator

Radicle Science, Inc

Eligibility Criteria

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

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

Treatment Details

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.

Participant Groups

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+

Findings from Research

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]

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]

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]

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]

References

1. United States pubmed.ncbi.nlm.nih.gov

TIDieR-Placebo: A guide and checklist for reporting placebo and sham controls. [2020]

2. Canada pubmed.ncbi.nlm.nih.gov

A guide to the pharmacology of placebos. [2022]

3. England pubmed.ncbi.nlm.nih.gov

Placebo interventions for all clinical conditions. [2022]

4. Germany pubmed.ncbi.nlm.nih.gov

[The placebo effect in medicine]. [2016]

5. United States pubmed.ncbi.nlm.nih.gov

Therapeutic effects of short-term monochromatic infrared energy therapy on patients with knee osteoarthritis: a double-blind, randomized, placebo-controlled study. [2022]

6. United States pubmed.ncbi.nlm.nih.gov

Sham procedure versus usual care as the control in clinical trials of devices: which is better? [2007]

7. England pubmed.ncbi.nlm.nih.gov

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

8. Scotland pubmed.ncbi.nlm.nih.gov

Credibility of a comparative sham control intervention for Craniosacral Therapy in patients with chronic neck pain. [2015]

9. Netherlands pubmed.ncbi.nlm.nih.gov

The use of natural products for sleep: A common practice? [2018]

10. United States pubmed.ncbi.nlm.nih.gov

Influence of a Suggestive Placebo Intervention on Psychobiological Responses to Social Stress: A Randomized Controlled Trial. [2015]

11. Germany pubmed.ncbi.nlm.nih.gov

[Appearances are not deceptive: clinical evidence and new research approaches to open-label placebo]. [2020]

12. Switzerland pubmed.ncbi.nlm.nih.gov

Open-Label Placebo Interventions With Drinking Water and Their Influence on Perceived Physical and Mental Well-Being. [2021]

13. England pubmed.ncbi.nlm.nih.gov

Developing and validating a sham cupping device. [2019]

14. England 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. [2022]