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Clinical Trial Details — Status: Completed

Administrative data

NCT number NCT05783232
Other study ID # RADX-22D07
Secondary ID
Status Completed
Phase N/A
First received
Last updated
Start date March 21, 2023
Est. completion date October 27, 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 of health and wellness product formulations and their effects on overall health


Description:

This is a randomized, blinded, placebo-controlled study conducted with adult participants, age 21 and older and residing in the United States. Eligible participants will (1) endorse a desire for better health during screening; (2) indicate an interest in taking a health and wellness product to potentially help improve their health, 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 will be 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 1494
Est. completion date October 27, 2023
Est. primary completion date June 9, 2023
Accepts healthy volunteers Accepts Healthy Volunteers
Gender All
Age group 21 Years to 105 Years
Eligibility Inclusion Criteria: - 21 years of age and older - Resides in the United States - Endorses: a desire for better sleep and/or focus, less pain, less feelings of stress, depression, and/or anxiety, and/or more energy (less fatigue) - Expresses a willingness to take a study product that may contain cannabinoids (or placebo) and not know the product identity 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 and mobile phone number - Reports a diagnosis of liver or kidney disease - Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day) - Reports current enrollment in a clinical trial - The QOL score greater than 5 during enrollment - Unable to read and understand English - Lack of reliable daily access to the internet - Reports taking any medication that warns against grapefruit consumption - 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:
Placebo Control Form 1 Capsules
Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.1 Capsules
Participants will use their Radicle Health Active Study Product 1.1 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.2 Capsules
Participants will use their Radicle Health Active Study Product 1.2 Capsules as directed for a period of 4 weeks.
Health Active Study Product 1.3 Capsules
Participants will use their Radicle Health Active Study Product 1.3 Capsules 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
Primary Change in overall health-related quality of life Mean difference in overall health score as assessed by Patient Reported Outcome Measurement System (PROMIS) 29+2 Profile (PROPr; scale 70-120; with higher scores corresponding to greater overall health across 7 health domains: physical function, ability to participate in social roles and activities, cognitive function, anxiety, depression, fatigue, sleep disturbance, pain interference and pain intensity) 4 weeks
Secondary Change in physical function Mean difference in physical function score as assessed by PROMIS PROPr items related to physical function (scale 4-20; with higher scores corresponding to greater physical function) 4 weeks
Secondary Change in feelings of anxiety Mean difference in feelings of anxiety score as assessed by PROMIS PROPr items related to anxiety (scale 4-20; with higher scores corresponding to more severe feelings of anxiety) 4 weeks
Secondary Change in feelings of depression Mean difference in feelings of depression score as assessed by PROMIS PROPr items related to depression (scale 4-20; with higher scores corresponding to more severe feelings of depression) 4 weeks
Secondary Change in fatigue Mean difference in fatigue score as assessed by PROMIS PROPr questions related to fatigue (scale 4-20; with higher scores corresponding to more severe fatigue) 4 weeks
Secondary Change in sleep disturbance Mean difference in sleep disturbance score as assessed by PROMIS PROPr items related to sleep disturbance (scale 4-20; with higher scores corresponding to greater sleep disturbance) 4 weeks
Secondary Change in socialization ability Mean difference in socialization ability score as assessed by PROMIS PROPr items related to (scale 4-20; with higher scores corresponding to greater ability to participate in social roles and activities) 4 weeks
Secondary Change in pain Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain) 4 weeks
Secondary Change in cognitive function Mean difference in cognitive function score as assessed by PROMIS PROPr items related to cognitive function (scale 2-10; with higher scores corresponding to greater cognitive function) 4 weeks
Secondary Change in libido Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; where higher scores correspond to greater interest in sexual activities) 4 weeks
Secondary Minimal clinical importance difference (MCID) in overall health-related quality of life Likelihood of achieving a MCID in overall health-related quality of life, as measured by PROMIS PROPr (scale 70-120; with higher scores corresponding to greater overall health-related quality of life) 4 weeks
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