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Wellness Products for Fatigue
N/A
Recruiting
Led By Emily K. Pauli, PharmD
Research Sponsored by Radicle Science
Eligibility Criteria Checklist
Specific guidelines that determine who can or cannot participate in a clinical trial Must have
Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study
Be older than 18 years old
Must not have
Unable to provide a valid US shipping address and mobile phone number
Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
Timeline
Screening 3 weeks
Treatment Varies
Follow Up 6 weeks
Summary
This trial is studying the effects of health and wellness products on fatigue and other health outcomes. It is a controlled study where some participants will receive the products and others will receive a placebo. The study is
Who is the study for?
This trial is for adults over 21 in the U.S. who want more energy and can improve their health by at least 20%. They must be willing to take a product without knowing if it's active or placebo. Excluded are those on certain medications, heavy drinkers, with recent major illness/surgery, heart/liver/kidney disease, or pregnant/breastfeeding.
What is being tested?
The study tests two different 'Energy Active' products against a placebo to see which one better reduces fatigue. Participants won't know what they're taking. It's randomized (assigned by chance) and double-blind (neither researchers nor participants know who gets what).
What are the potential side effects?
While specific side effects aren't listed, typical risks may include allergic reactions or gastrointestinal issues due to unknown ingredients in the wellness products being tested.
Eligibility Criteria
Inclusion Criteria
You may be eligible if you check “Yes” for the criteria belowSelect...
I am willing to take a study drug without knowing if it's active or a placebo.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I cannot provide a valid US address and mobile number.
Select...
I do not have severe heart, liver, or kidney disease that could make the study unsafe for me.
Timeline
Screening ~ 3 weeks3 visits
Treatment ~ Varies
Follow Up ~ 6 weeks
Screening ~ 3 weeks
Treatment ~ Varies
Follow Up ~6 weeks
Treatment Details
Study Objectives
Study objectives can provide a clearer picture of what you can expect from a treatment.Primary study objectives
Change in fatigue
Secondary study objectives
Change in cognitive function
Change in sleep
Minimal clinically important difference (MCID) in cognitive function
+2 moreOther study objectives
Change in at-home (direct-to-consumer) specimen assays
Change in mood (emotional distress-depression)
Trial Design
11Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Product 4.3Experimental Treatment1 Intervention
Energy Product Form 4 - active product 3
Group II: Active Product 4.2Experimental Treatment1 Intervention
Energy Product Form 4 - active product 2
Group III: Active Product 4.1Experimental Treatment1 Intervention
Energy Product Form 4 - active product 1
Group IV: Active Product 3.1Experimental Treatment1 Intervention
Energy Product Form 3 - active product 1
Group V: Active Product 2.1Experimental Treatment1 Intervention
Energy Product Form 2 - active product 1
Group VI: Active Product 1.2Experimental Treatment1 Intervention
Energy Product Form 1 - active product 2
Group VII: Active Product 1.1Experimental Treatment1 Intervention
Energy Product Form 1 - active product 1
Group VIII: Placebo Control 2Placebo Group1 Intervention
Energy Product Form 2 - control
Group IX: Placebo Control 4Placebo Group1 Intervention
Energy Product Form 4 - control
Group X: Placebo Control 1Placebo Group1 Intervention
Energy Product Form 1 - control
Group XI: Placebo Control 3Placebo Group1 Intervention
Energy Product Form 3 - control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Energy Active Study Product 1.2 Usage
2023
N/A
~1190
Energy Active Study Product 1.1 Usage
2023
N/A
~1190
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Who is running the clinical trial?
Radicle ScienceLead Sponsor
21 Previous Clinical Trials
42,301 Total Patients Enrolled
Emily K. Pauli, PharmDPrincipal InvestigatorRadicle Science, Inc
17 Previous Clinical Trials
34,774 Total Patients Enrolled