Radicle Health1: A Study of Health and Wellness Formulations and Their Effects on Overall Health

Depression Clinical Trial

Official title:

Radicle™ Health1: A Randomized, Blinded, Placebo-controlled Study of Health and Wellness Formulations and Their Effects on Overall Health

Clinical Trial Details — Status: Completed

Administrative data

• NCT number: NCT05783232
• Other study ID #: RADX-22D07
• Status: Completed
• Phase: N/A
• 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
• 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

Related Conditions & MeSH terms

• Anxiety
• Depression
• Pain
• Sleep

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

External Links

•   Radicle Science, Inc