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

Description

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

Conditions

Abdominal Pain, GI Disorders, Digestion

Study Overview

Study Details

Study overview

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

Radicle GI Health™ 24: A Randomized, Double-Blind, Placebo-Controlled, Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Gastrointestinal (GI) Health and Related Health Outcomes

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

Condition
Abdominal Pain
Intervention / Treatment

-

Contacts and Locations

Del Mar

Radicle Science, Inc, Del Mar, California, United States, 92014

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

For general information about clinical research, read Learn About Studies.

Eligibility Criteria

  • * Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities. Assigned sex at birth will determine sex-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 fewer stomach 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
  • * 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 per day)
  • * Unable to read and understand English
  • * Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.
  • * Reports a diagnosis of cardiac dysfunction, liver or kidney disease that presents a known contraindication and/or a significant safety risk with any of the study product ingredients. NYHA (New York Heart Association) Class Ill or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure
  • * Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients. Anticoagulants, antihypertensives, anxiolytics, antidepressants, chemotherapy, immunotherapy, sedative hypnotics, seizure medications, medications that warn against grapefruit consumption, corticosteroids at doses greater than 5 mg per day, diabetic medications, oral anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection, antipsychotics, MAOls (monoamine oxidase inhibitors), or thyroid products
  • * Reports current use of the primary ingredient(s) and/or similar product(s) to the active study product(s) that may limit the effects of the study product
  • * Lack of reliable daily access to the internet

Ages Eligible for Study

21 Years to 105 Years

Sexes Eligible for Study

ALL

Accepts Healthy Volunteers

Yes

Collaborators and Investigators

Radicle Science,

Emily K. Pauli, PharmD, PRINCIPAL_INVESTIGATOR, Radicle Science, Inc

Study Record Dates

2025-12