Health and Wellness Products for Overall Health
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.12345Why 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.16789
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
Exclusion Criteria
Timeline for a Trial Participant
Screening
Participants are screened for eligibility to participate in the trial
Treatment
Participants receive the study product or placebo for 7 weeks, with self-reported data collected electronically
Follow-up
Participants are monitored for safety and effectiveness after treatment
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?
5
Treatment groups
Experimental Treatment
Placebo Group
Health product 7.2.1 - active product 1
Health product 7.1.2 - active product 2
Health product 7.1.1 - active product 1
Health product 7.2.0 - control
Health product 7.1.0 - control
Find a Clinic Near You
Who Is Running the Clinical Trial?
Radicle Science
Lead Sponsor
Citations
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.
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.
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 ...
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.
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-outcomRadicle 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.
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.
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 ...
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 ...
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