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

Last updated: November 20, 2023
Sponsor: Radicle Science
Overall Status: Completed

Phase

N/A

Condition

Depression

Pain

Treatment

Health Active Study Product 1.1 Capsules

Placebo Control Form 1 Capsules

Health Active Study Product 1.3 Capsules

Clinical Study ID

NCT05783232
RADX-22D07
  • Ages 21-105
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

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

Eligibility Criteria

Inclusion

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 (orplacebo) and not know the product identity until the end of the study

Exclusion

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 perday)
  • 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, ororal anti-infectives (antibiotics, antifungals, antivirals) to treat an acuteinfection

Study Design

Total Participants: 1494
Treatment Group(s): 4
Primary Treatment: Health Active Study Product 1.1 Capsules
Phase:
Study Start date:
March 21, 2023
Estimated Completion Date:
October 27, 2023

Study 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.

Connect with a study center

  • Radicle Science, Inc

    Del Mar, California 92014
    United States

    Site Not Available

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