Radicle GI Health 24: A Study of Health and Wellness Products on GI Health and Related Health Outcomes

Last updated: February 24, 2025
Sponsor: Radicle Science
Overall Status: Active - Recruiting

Phase

N/A

Condition

Dysmenorrhea (Painful Periods)

Ulcerative Colitis (Pediatric)

Colic

Treatment

Radicle GI Health Placebo Control Form 1

Radicle GI Health Active Study Product 5.1 Usage

Radicle GI Health Placebo Control Form 5

Clinical Study ID

NCT06376695
RADX-P-2407
  • Ages 21-105
  • All Genders
  • Accepts Healthy Volunteers

Study Summary

A randomized, double-blind, placebo-controlled study assessing the impact of health and wellness products on GI health and related health outcomes

Eligibility Criteria

Inclusion

Inclusion Criteria:

  • Adults, at least 21 years of age at the time of electronic consent, inclusive of allethnicities, races, and gender identities. Assigned sex at birth will determinesex-specific recruitment and surveys (male vs female) employed, when needed

  • Resides in the United States

  • Endorses a desire for improved bowel habits, less bloating/indigestion, and/or fewerstomach aches/pains

  • Has the opportunity for at least 20% improvement in their primary health outcome

  • Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study

Exclusion

Exclusion Criteria:

  • Report being pregnant, trying to become pregnant, or breastfeeding

  • Unable to provide a valid US shipping address and mobile phone number

  • Reports current enrollment in another clinical trial

  • Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages perday)

  • Unable to read and understand English

  • Reports a current and/or recent (up to 3 months ago) major illness and/or surgerythat poses a known, significant safety risk.

  • Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents aknown contraindication and/or a significant safety risk with any of the studyproduct ingredients. NYHA (New York Heart Association) Class Ill or IV congestiveheart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stageliver disease, stage 3b or 4 chronic kidney disease, or kidney failure

  • Reports taking medications that have a well-established moderate or severeinteraction, posing a substantial safety risk with any of the study productingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants,chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medicationsthat warn against grapefruit consumption, corticosteroids at doses greater than 5 mgper day, diabetic medications, oral anti-infectives (antibiotics, antifungals,antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidaseinhibitors), or thyroid products

  • Reports current use of the primary ingredient(s) and/or similar product(s) to theactive study product(s) that may limit the effects of the study product

  • Lack of reliable daily access to the internet

Study Design

Total Participants: 2100
Treatment Group(s): 20
Primary Treatment: Radicle GI Health Placebo Control Form 1
Phase:
Study Start date:
March 19, 2024
Estimated Completion Date:
December 31, 2025

Study Description

This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.

Eligible participants will (1) endorse a desire for improved bowel habits, less bloating/indigestion, and/or fewer stomach aches/pains (2) have the opportunity for meaningful improvement (at least 20%) in their primary health outcome, and (3) express acceptance in taking a product and not knowing its formulation until the end of the study.

Participants that report a known cardiac dysfunction, liver or kidney disease may be excluded. Participants that report a known contraindication or with well-established, significant safety concerns due to illness will be excluded. Heavy drinkers and those who report they are pregnant, trying to become pregnant, or breastfeeding will be excluded. Participants that report taking medications with a known contraindication or with well-established, significant safety concerns will be excluded.

Self-reported data are collected electronically from eligible participants for 7 weeks. Participant reports of health indicators will be collected at 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

    Active - Recruiting

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