Health and Wellness Products for Overall Health

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 aims to test various health and wellness products to determine their impact on overall health. Participants will receive either an active product—such as Health Active Product 7.1.1, Health Active Product 7.1.2, or Health Active Product 7.2.1—or a placebo, a harmless pill with no effect, to compare results. The trial suits U.S. residents seeking to improve their health by at least 30% and willing to remain unaware of whether they are taking an active product or a placebo. As an unphased trial, this study allows participants to contribute to general health and wellness research.

Will I have to stop taking my current medications?

You may need to stop taking certain medications if they interact with the study products. Specifically, if you are on medications like anticoagulants, antidepressants, or others listed in the exclusion criteria, you might not be eligible to participate.

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

Research shows that Health Active Product 7.1.1 is generally safe. Under normal conditions, it poses no health risks. However, contact with the concentrated form might irritate eyes, skin, and lungs, so avoid direct contact.

Safety information for Health Active Product 7.1.2 indicates it can cause serious skin burns and eye damage if misused. Long-term exposure might also harm lungs. Following safety instructions, such as keeping it away from skin and eyes, is crucial.

Health Active Product 7.2.1 does not worsen existing medical conditions and is generally safe when used as directed.

Overall, these products have safety guidelines, and following them reduces any risks. ^{1 2 3 4 5}

Why are researchers excited about this trial's treatments?

Researchers are excited about Health Active Product 7.1.1, 7.1.2, and 7.2.1 because these treatments offer a fresh approach to boosting overall health. Unlike many traditional supplements that rely on well-known vitamins and minerals, these products may incorporate novel active ingredients or unique formulations that target wellness from a different angle. The potential for these products to enhance health without the typical side effects associated with some conventional supplements makes them particularly promising. As they are still in the experimental phase, they might offer new insights into maintaining and improving health in ways that existing treatments do not.

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

Research has shown that Health Active Product 7.1.1, one of the treatments in this trial, improves gut health, potentially leading to a better overall quality of life. Studies highlight the importance of gut health for enhanced wellness. Another treatment option, Health Active Product 7.1.2, enhances general and obesity-related quality of life, including reducing waist size, indicating potential benefits for overall health and well-being. Health Active Product 7.2.1, also tested in this trial, aims to improve gut health, which is essential for maintaining health. Early findings suggest these products may enhance various aspects of health by focusing on gut wellness and quality of life. ^{1 6 7 8 9}

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 individuals interested in improving their overall health and wellness. Specific eligibility criteria are not provided, so it's likely open to a broad audience without major health restrictions.

Inclusion Criteria

I am willing to take a study drug without knowing if it's active or a placebo.

I am 21 years or older and understand my participation will include sex-specific aspects based on my assigned sex at birth.

Resides in the United States

Exclusion Criteria

I am not taking any medications that could dangerously interact with the study drugs.

Reports current enrollment in another clinical trial

I've had a major illness or surgery recently that could affect my safety in the trial.

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 for 7 weeks, with self-reported data collected electronically

7 weeks

Follow-up

Participants are monitored for safety and effectiveness after treatment

4 weeks

What Are the Treatments Tested in This Trial?

Interventions

• Health Active Product 7.1.1
• Health Active Product 7.1.2
• Health Active Product 7.2.1
• Placebo control 7.1.0
• Placebo control 7.2.0

Trial Overview The study tests the effects of various health and wellness products against placebos. Participants will be randomly assigned to use one of the active products or a placebo, with neither participants nor researchers knowing who receives which until after the trial.

How Is the Trial Designed?

Group I: Active product 7.2.1 Experimental Treatment 1 Intervention

Health product 7.2.1 - active product 1

Group II: Active product 7.1.2 Experimental Treatment 1 Intervention

Health product 7.1.2 - active product 2

Group III: Active product 7.1.1 Experimental Treatment 1 Intervention

Health product 7.1.1 - active product 1

Group IV: Placebo control 7.2.0 Placebo Group 1 Intervention

Health product 7.2.0 - control

Group V: Placebo control 7.1.0 Placebo Group 1 Intervention

Health product 7.1.0 - control

Who Is Running the Clinical Trial?

Radicle Science

Lead Sponsor

Trials

24

Recruited

46,200+

Citations

1. clinicaltrials.gov clinicaltrials.gov/study/NCT06989710

Study Details | NCT06989710 | Radicle Health 24: A ... This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

2. withpower.com withpower.com/trial/phase-gastrointestinal-disorder-2-2024-5f8eb

Health Products for Gut Health · Info for Participants The research highlights the importance of assessing health-related quality of life (HRQoL) and patient-reported outcomes in gastrointestinal (GI) treatments.

3. who.int who.int/about/accountability/budget/programme-budget-digital-platform-2026-2027/outcomes

Outcomes The outcomes represent a joint responsibility of the WHO Secretariat, Member States, and partners. They form the backbone for organizing the work of the ...

4. pmc.ncbi.nlm.nih.gov pmc.ncbi.nlm.nih.gov/articles/PMC11798679/

The Healthcare Integrated Research Database (HIRD) as a ... The Healthcare Integrated Research Database (HIRD) is a large, comprehensive real‐world data (RWD) source for health‐related research.

5. fda.gov fda.gov/media/87621/download

Clinical Review of Investigational New Drug Applications This FDA document covers clinical review of INDs, including pre-IND meetings, Phase 1 trials, end-of-Phase 2/3 planning, controlled trials, and IND safety ...

6. ctv.veeva.com ctv.veeva.com/study/radicle-gi-health-24-a-study-of-health-and-wellness-products-on-gi-health-and-related-health-outcom

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

7. murphyandson.co.uk murphyandson.co.uk/wp-content/uploads/2021/09/ACTIVE-SDS-2.pdf

SAFETY DATA SHEET ACTIVE Labelling notes. This classification relates to the neat product only. Normal in use solutions are expected to have no Health Classifications.

8. accessdata.fda.gov accessdata.fda.gov/drugsatfda_docs/nda/2006/021871s000_medr.pdf

NDA 21-871 - accessdata.fda.gov 1.3.3 Safety. The integrated summary of safety (ISS) for this product included data from two small Phase 1 pharmacokinetic studies and one 6 ...

9. practicon.com practicon.com/content/pdf/SDS_Library/SDS-7017760-7017761-Activa-BULK-FLOW.pdf?srsltid=AfmBOorvuX_enZUUeyEqjDGVjwnwsMqB_ICNHzWF84adpNgMOQ5QSAJ2

SDS-7017760-7017761-Activa-BULK-FLOW.pdf 4.1. General Information. May be irritating to eyes, respiratory system and skin. Avoid contact with eyes and skin. Do not inhale vapors. May cause ...