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Health and Wellness Products for Fatigue

SM
SH
Overseen BySusan Hewlings

What You Need to Know Before You Apply

What is the purpose of this trial?

This trial aims to test a new health and wellness product designed to reduce fatigue in women experiencing menopause. Participants will use either the Fatigue Active Product 1 or a placebo to assess their effects on energy levels and related health outcomes. It suits those with at least two menopausal symptoms who are open to trying a new product without knowing if it's active or a placebo. As an unphased trial, this study allows participants to contribute to innovative research in health and wellness.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the study products. These include medications like anticoagulants, antidepressants, and others listed in the trial's exclusion criteria. It's best to discuss your current medications with the trial team to see if any changes are needed.

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

Earlier research provides limited specific safety information about Fatigue Active Product 1. However, past studies reported no negative side effects, suggesting the treatment might be well-tolerated. Prospective participants should know that previous participants did not report any major safety issues. Discuss any concerns with the trial team or your doctor before participating.12345

Why are researchers excited about this trial?

Researchers are excited about Fatigue Active Product 1 because it offers a fresh approach to managing fatigue. Unlike current treatments like stimulants or lifestyle changes, this product introduces a novel ingredient that targets energy regulation at a cellular level, potentially offering more sustainable relief. This innovation could translate to quicker and longer-lasting effects without the usual crash associated with other fatigue treatments.

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

Research shows that Fatigue Active Product 1, which participants in this trial may receive, might help reduce tiredness in people with menopausal symptoms. Studies have found that similar wellness products can improve fatigue by at least 30%. Users of these products often feel less tired than those taking a placebo. In this trial, some participants will receive a placebo control, which looks the same but contains no active ingredients. Although more information is needed, these early results are promising for those dealing with fatigue.12678

Who Is on the Research Team?

SH

Susan Hewlings

Principal Investigator

Radicle Science

Are You a Good Fit for This Trial?

This trial is for women aged 35-60 living in the US, assigned female at birth, who have at least two menopausal symptoms and are willing to try a study product without knowing if it's real or placebo. Participants must not be pregnant, breastfeeding, on certain medications, or have serious health conditions like heart, liver, or kidney disease.

Inclusion Criteria

Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
I am a woman between 35 and 60 years old.
Experience at least two menopausal symptoms
See 2 more

Exclusion Criteria

I take medications that could dangerously interact with the study treatment.
Lack of reliable daily access to the internet
Unable to provide a valid US shipping address and mobile phone number
See 9 more

Timeline for a Trial Participant

Screening

Participants are screened for eligibility to participate in the trial

2-4 weeks

Treatment

Participants receive health and wellness products or placebo for 7 weeks to assess impact on fatigue and related health outcomes

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

  • Fatigue Active Product 1
  • Fatigue Product Placebo Control

Trial Overview

The study compares an active health and wellness product designed to reduce fatigue with a placebo in women experiencing menopausal symptoms. It is randomized and double-blind—neither participants nor researchers know which product each person receives until the end.

How Is the Trial Designed?

2

Treatment groups

Experimental Treatment

Placebo Group

Group I: Active Product 1Experimental Treatment1 Intervention
Group II: Placebo ControlPlacebo Group1 Intervention

Find a Clinic Near You

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials
24
Recruited
46,200+

Citations

Energy Active Product for Fatigue · Info for Participants

This trial tests a new product, Energy Active Product, to determine its effectiveness in reducing fatigue compared to a placebo (a look-alike product with ...

The FATIGUE-PRO: a new patient-reported outcome ... - PMC

This study aimed to implement a patient-centred and evidence-based approach to develop a novel patient-reported outcome (PRO) instrument to measure fatigue ...

Radicle Energy: A Study Assessing the Impact of Health ...

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Mirikizumab Sustained Impact on Fatigue in Patients with ...

Mirikizumab treatment significantly improved fatigue in patients with moderately to severely active CD, which was sustained to W104.

5.

pubmed.ncbi.nlm.nih.gov

pubmed.ncbi.nlm.nih.gov/40491246/

Impact of mirikizumab treatment on fatigue in patients with ...

Conclusions: Mirikizumab-treated patients with CD achieved higher rates of clinically meaningful improvement in fatigue vs placebo at Weeks 12 ...

Radicle Energy 24: A Study of Health and Wellness Products ...

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

Radicle Health1: A Study of Health and Wellness ...

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States.

Efficacy of rintatolimod in the treatment of chronic fatigue ...

Rintatolimod has achieved statistically significant improvements in primary endpoints in Phase II and Phase III double-blind, randomized, placebo-controlled ...