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Completed

NCT Number: NCT05783232

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

A randomized, blinded, placebo-controlled study of health and wellness product formulations and their effects on overall health

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Key information

Conditions

Sleep Anxiety Anxiety Disorders Behavior Behavioral Symptoms Depression Mental Disorders Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Signs and Symptoms

Age range

21 year–105 year

Sex eligibility

All sexes

Study type

Interventional

Phase

Not applicable

Primary location

Radicle Science, Inc

Del Mar, California, 92014, United States

About this study

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.

Who can participate

Healthy volunteers accepted: Yes

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Placebo Control Form 1 Capsules

Dietary Supplement

Participants will use their Placebo Control Form 1 Capsules as directed for a period of 4 weeks.

Health Active Study Product 1.1 Capsules

Dietary Supplement

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

Dietary Supplement

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

Dietary Supplement

Participants will use their Radicle Health Active Study Product 1.3 Capsules as directed for a period of 4 weeks.

Primary outcomes

  1. Change in overall health-related quality of life

    Time frame: 4 weeks

    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)

Secondary outcomes

  1. Change in physical function

    Time frame: 4 weeks

    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)

  2. Change in feelings of anxiety

    Time frame: 4 weeks

    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)

  3. Change in feelings of depression

    Time frame: 4 weeks

    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. Change in fatigue

    Time frame: 4 weeks

    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)

  5. Change in sleep disturbance

    Time frame: 4 weeks

    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)

  6. Change in socialization ability

    Time frame: 4 weeks

    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)

  7. Change in pain

    Time frame: 4 weeks

    Mean difference in pain score as assessed by PROMIS PROPr items related to pain (scale 1-15; with higher scores corresponding to greater pain)

  8. Change in cognitive function

    Time frame: 4 weeks

    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)

  9. Change in libido

    Time frame: 4 weeks

    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)

  10. Minimal clinical importance difference (MCID) in overall health-related quality of life

    Time frame: 4 weeks

    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)

Sponsors and collaborators

Lead sponsor

Radicle Science

Industry

Registry information

Official study title

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

Important dates

Study start
2023
Primary completion
2023
Study completion
2023
First posted
Mar 24, 2023
Registry last updated
Nov 22, 2023

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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