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Dietary Supplement
Wellness Products for Anxiety
N/A
Waitlist Available
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
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 will test the effects of health and wellness products on anxiety and overall health in a fair and unbiased way.
Who is the study for?
Adults over 21 in the US who want to reduce anxiety and can improve their health by at least 20%. Must be willing to take an unknown product (active or placebo) and have internet access. Excludes those with major recent illnesses, heavy drinkers, certain chronic diseases, pregnant/breastfeeding women, other trial participants, and those on conflicting medications.
What is being tested?
The study is testing a 'Calm Active Study Product' against a placebo to see if it helps with anxiety. Participants won't know which one they're taking. It's randomized (assigned by chance) and double-blind (neither researchers nor participants know who's getting what).
What are the potential side effects?
Since this is a wellness product study focusing on reducing anxiety, specific side effects are not listed but typically could include digestive discomfort, headaches or drowsiness depending on the ingredients of the active product.
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 real or a placebo.
Exclusion Criteria
You may be eligible for the trial if you check “No” for criteria below:Select...
I have serious heart, liver, or kidney conditions 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 feelings of anxiety
Secondary study objectives
Change in mood (emotional distress)
Change in sleep
Change in stress
+4 moreOther study objectives
Change in blood concentration of at-home (direct-to-consumer) specimen assay (1)
Change in blood concentration of at-home (direct-to-consumer) specimen assay (10)
Change in blood concentration of at-home (direct-to-consumer) specimen assay (11)
+20 moreTrial Design
2Treatment groups
Experimental Treatment
Placebo Group
Group I: Active Product 1.1Experimental Treatment1 Intervention
Calm Product Form 1 - active product 1
Group II: Placebo Control 1Placebo Group1 Intervention
Calm Product Form 1 - control
Treatment
First Studied
Drug Approval Stage
How many patients have taken this drug
Calm Active Study Product 1.1 Usage
2023
N/A
~3860
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Who is running the clinical trial?
Radicle ScienceLead Sponsor
21 Previous Clinical Trials
44,049 Total Patients Enrolled
5 Trials studying Anxiety
10,908 Patients Enrolled for Anxiety
Emily K. Pauli, PharmDPrincipal InvestigatorRadicle Science, Inc
17 Previous Clinical Trials
36,522 Total Patients Enrolled
3 Trials studying Anxiety
6,558 Patients Enrolled for Anxiety
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