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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05589935
Other study ID # RADX-22D05
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date November 22, 2022
Est. completion date May 24, 2023

Study information

Verified date November 2023
Source Radicle Science
Contact n/a
Is FDA regulated No
Health authority
Study type Interventional

Clinical Trial Summary

A randomized, blinded, placebo-controlled study assessing the impact of health and wellness products on pain and other health outcomes


Description:

This is a randomized, blinded, placebo-controlled study conducted with up to 300 adult participants per study arm, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for less pain, (2) indicate an interest in taking a health and wellness product to potentially help relieve their pain, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study. Participants with known liver or kidney disease, heavy drinkers, and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking certain medications will be excluded. Self-reported data are collected electronically from eligible participants over 5 weeks. Participant reports of health indicators will be collected during baseline, throughout the active period of study product use, and in a final survey. All study assessments will be electronic; there are no in-person visits or assessments for this real-world evidence study


Recruitment information / eligibility

Status Completed
Enrollment 457
Est. completion date May 24, 2023
Est. primary completion date December 23, 2022
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 105 Years
Eligibility Inclusion Criteria: - Adults, 21 years of age and older at the time of electronic consent, inclusive of all ethnicities, races, genders and/or gender identities - Resides in the United States - Endorses pain as a primary issue (desire for less pain) - Selects their desire for less pain and/or reduce reliance on medications as a reason for their interest in taking a health and wellness product - Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study Exclusion Criteria: - Reports being pregnant, trying to become pregnant, or breastfeeding - Unable to provide a valid physical shipping address - Reports a diagnosis of liver or kidney disease - Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) - Unable to read and understand English - Lack of reliable daily access to the internet - Reports taking anticoagulants, any medication that warns against grapefruit consumption, corticosteroids at doses greater than 5 mgs per day, or MAOIs - Reports current or recent (within 3 months) use of chemotherapy, immunotherapy, or oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection

Study Design


Related Conditions & MeSH terms


Intervention

Dietary Supplement:
Relief Study Product Usage
Participants instructed to use study product daily as directed for a period of 4 weeks

Locations

Country Name City State
United States Radicle Science, Inc Del Mar California

Sponsors (1)

Lead Sponsor Collaborator
Radicle Science

Country where clinical trial is conducted

United States, 

Outcome

Type Measure Description Time frame Safety issue
Other Change in energy (fatigue) Mean difference in fatigue score as assessed by PROMIS Fatigue 4A [scale 4-20; with higher scores corresponding to greater fatigue] 4 weeks
Other Change in cognitive function Mean difference in cognitive function score as assessed by PROMIS Cognitive Function 4A [scale 4-20; with higher scores corresponding to greater cognitive function] 4 weeks
Other Change in emotional distress Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A [scale 4-20; with higher scores corresponding to greater levels of emotional distress] 4 weeks
Other Change in sexual interest Mean difference in sexual interest as assessed by PROMIS Sexual Interest 2.0 [scale 2-10; with higher scores corresponding to greater interest in sexual activity] 4 weeks
Primary Change in pain interference Mean difference in pain interference score as assessed by Patient Reported Outcome Measurement System (PROMIS) Pain Interference 6A [scale 6-30; with higher scores corresponding to greater pain interference] 4 weeks
Secondary Change in neuropathic pain Mean difference in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A [scale 5-25; with higher scores corresponding to greater neuropathic pain] 4 weeks
Secondary Change in nociceptive pain Mean difference in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A [scale 5-25; with higher scores corresponding to greater nociceptive pain] 4 weeks
Secondary Change in pain intensity Mean difference in pain intensity score as assessed by PROMIS Pain Intensity 1A [scale 1-10; with 0 being 'No pain' and 10 being 'The worst imaginable pain'] 4 weeks
Secondary Change in feelings of anxiety Mean difference in anxiety score as assessed by PROMIS Anxiety 4A [scale 4-20; with higher scores corresponding to more severe anxiety] 4 weeks
Secondary Change in sleep disturbance Mean difference in sleep disturbance score as assessed by PROMIS Sleep Disturbance Form 4A [scale 4-20; with higher scores corresponding to more severe sleep disturbance] 4 weeks
Secondary Minimal clinically important difference (MCID) in pain interference Likelihood of experiencing MCID in pain interference score as assessed by PROMIS Pain Interference 6A 4 weeks
Secondary Minimal clinically important difference (MCID) in neuropathic pain Likelihood of experiencing MCID in neuropathic pain score as assessed by PROMIS Neuropathic Pain 5A 4 weeks
Secondary Minimal clinically important difference (MCID) in nociceptive pain Likelihood of experiencing MCID in nociceptive pain score as assessed by PROMIS Nociceptive Pain 5A 4 weeks
Secondary Minimal clinically important difference (MCID) in pain intensity Likelihood of experiencing MCID in pain intensity score as assessed by PROMIS Pain Intensity 1A 4 weeks
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