xml: <clinical_study>
    <!-- This xml conforms to an XML Schema at:
      https://clinicaltrials.gov/ct2/html/images/info/public.xsd -->
    <required_header>
      <download_date>ClinicalTrials.gov processed this data on September 20, 2023</download_date>
      <link_text>Link to the current ClinicalTrials.gov record.</link_text>
      <url>https://clinicaltrials.gov/ct2/show/NCT06009614</url>
    </required_header>
    <id_info>
      <org_study_id>RADX-2307</org_study_id>
      <nct_id>NCT06009614</nct_id>
    </id_info>
    <brief_title>Radicle GI Health: A Study of Health and Wellness Products on GI Health and Other Health Outcomes</brief_title>
    <official_title>Radicle™ GI Health: A Randomized, Blinded, Placebo-Controlled Direct-to-Consumer Study of Health and Wellness Products on Gastrointestinal (GI) Health and Other Health Outcomes</official_title>
    <sponsors>
      <lead_sponsor>
        <agency>Radicle Science</agency>
        <agency_class>Industry</agency_class>
      </lead_sponsor>
    </sponsors>
    <source>Radicle Science</source>
    <oversight_info>
      <has_dmc>No</has_dmc>
      <is_fda_regulated_drug>No</is_fda_regulated_drug>
      <is_fda_regulated_device>No</is_fda_regulated_device>
    </oversight_info>
    <brief_summary>
      <textblock>
        A randomized, blinded, placebo-controlled study assessing the impact of health and wellness&#xD;
        products on gastrointestinal (GI) health and other health outcomes&#xD;
      </textblock>
    </brief_summary>
    <detailed_description>
      <textblock>
        This is a randomized, blinded, placebo-controlled study conducted with adult participants,&#xD;
        age 21 and older and residing in the United States.&#xD;
  &#xD;
        Eligible participants will (1) endorse a desire for less bloating or indigestion, (2)&#xD;
        indicate an interest in taking a health and wellness product to potentially help their&#xD;
        bloating or indigestion, and (3) express acceptance in taking a product and not knowing its&#xD;
        formulation until the end of the study.&#xD;
  &#xD;
        Participants with known liver or kidney disease, heavy drinkers, and those who report they&#xD;
        are pregnant, trying to become pregnant, or breastfeeding will be excluded. Those taking&#xD;
        certain medications will be excluded.&#xD;
  &#xD;
        Self-reported data are collected electronically from eligible participants over 7 weeks.&#xD;
        Participant reports of health indicators will be collected during baseline, throughout the&#xD;
        active period of study product use, and in a final survey. All study assessments will be&#xD;
        electronic; there are no in-person visits or assessments for this real-world evidence study.&#xD;
      </textblock>
    </detailed_description>
    <overall_status>Recruiting</overall_status>
    <start_date type="Anticipated">September 4, 2023</start_date>
    <completion_date type="Anticipated">February 15, 2024</completion_date>
    <primary_completion_date type="Anticipated">October 16, 2023</primary_completion_date>
    <phase>N/A</phase>
    <study_type>Interventional</study_type>
    <has_expanded_access>No</has_expanded_access>
    <study_design_info>
      <allocation>Randomized</allocation>
      <intervention_model>Parallel Assignment</intervention_model>
      <intervention_model_description>Participants will be stratified based on gender at birth then randomized to one of the study arms</intervention_model_description>
      <primary_purpose>Other</primary_purpose>
      <masking>Single (Participant)</masking>
      <masking_description>Participants will be blinded to the product they receive.</masking_description>
    </study_design_info>
    <primary_outcome>
      <measure>Change in GI (Gastrointestinal) - related Quality of Life (QOL)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)</description>
    </primary_outcome>
    <secondary_outcome>
      <measure>Change in abdominal pain</measure>
      <time_frame>6 weeks</time_frame>
      <description>Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in gas/bloating</measure>
      <time_frame>6 weeks</time_frame>
      <description>Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Change in feelings of anxiety</measure>
      <time_frame>6 weeks</time_frame>
      <description>Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal clinically important difference (MCID) in GI-related QOL</measure>
      <time_frame>6 weeks</time_frame>
      <description>Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal clinically important difference (MCID) in abdominal pain</measure>
      <time_frame>6 weeks</time_frame>
      <description>Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A</description>
    </secondary_outcome>
    <secondary_outcome>
      <measure>Minimal clinically important difference (MCID) in gas/bloating</measure>
      <time_frame>6 weeks</time_frame>
      <description>Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A</description>
    </secondary_outcome>
    <other_outcome>
      <measure>Change in mood (emotional distress-depression)</measure>
      <time_frame>6 weeks</time_frame>
      <description>Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)</description>
    </other_outcome>
    <other_outcome>
      <measure>Change in libido</measure>
      <time_frame>6 weeks</time_frame>
      <description>Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)</description>
    </other_outcome>
    <number_of_arms>2</number_of_arms>
    <enrollment type="Anticipated">800</enrollment>
    <condition>Digestion</condition>
    <condition>Abdominal Pain</condition>
    <condition>GI Disorders</condition>
    <arm_group>
      <arm_group_label>Placebo Control 1</arm_group_label>
      <arm_group_type>Placebo Comparator</arm_group_type>
      <description>GI Health Product Form 1 - control</description>
    </arm_group>
    <arm_group>
      <arm_group_label>Active Product 1.1</arm_group_label>
      <arm_group_type>Experimental</arm_group_type>
      <description>GI Health Product Form 1 - active product 1</description>
    </arm_group>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>Placebo Control Form 1</intervention_name>
      <description>Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.</description>
      <arm_group_label>Placebo Control 1</arm_group_label>
    </intervention>
    <intervention>
      <intervention_type>Dietary Supplement</intervention_type>
      <intervention_name>GI Health Active Study Product 1.1</intervention_name>
      <description>Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.</description>
      <arm_group_label>Active Product 1.1</arm_group_label>
    </intervention>
    <eligibility>
      <criteria>
        <textblock>
          Inclusion Criteria:&#xD;
  &#xD;
            -  Adults, 21 years of age and older at the time of electronic consent, inclusive of all&#xD;
               ethnicities, races, and gender identities&#xD;
  &#xD;
            -  Resides in the United States&#xD;
  &#xD;
            -  Endorses less bloating or indigestion as a primary desire&#xD;
  &#xD;
            -  Has the opportunity for at least 20% improvement in their primary health outcome score&#xD;
  &#xD;
            -  Expresses a willingness to take a study product and not know the product identity&#xD;
               (active or placebo) until the end of the study&#xD;
  &#xD;
          Exclusion Criteria:&#xD;
  &#xD;
            -  Reports being pregnant, trying to become pregnant, or breastfeeding&#xD;
  &#xD;
            -  Unable to provide a valid US shipping address and mobile phone number&#xD;
  &#xD;
            -  The calculated validated health survey (PRO) score during enrollment represents less&#xD;
               than mild severity&#xD;
  &#xD;
            -  Reports a diagnosis of liver or kidney disease&#xD;
  &#xD;
            -  Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per&#xD;
               day)&#xD;
  &#xD;
            -  Unable to read and understand English&#xD;
  &#xD;
            -  Reports current enrollment in another clinical trial&#xD;
  &#xD;
            -  Lack of reliable daily access to the internet&#xD;
  &#xD;
            -  Reports current or recent (within 3 months) use of chemotherapy or immunotherapy&#xD;
  &#xD;
            -  Reports taking medications with a known moderate or severe interaction with any of the&#xD;
               active ingredients studied, or a substantial safety risk: Anticoagulants,&#xD;
               antihypertensives, anti-anxiolytics, antidepressants, medications that warn against&#xD;
               grapefruit consumption, corticosteroids at doses greater than 5 mg per day, oral&#xD;
               anti-infectives (antibiotics, antifungals, antivirals) to treat an acute infection,&#xD;
               antipsychotics, MAOIs (monoamine oxidase inhibitors), or thyroid products&#xD;
  &#xD;
            -  Reports a diagnosis of heart disease when a known contraindication exists for any of&#xD;
               the active ingredients studied: NYHAA (New York Heart Association) Class III or IV&#xD;
               congestive heart failure, Atrial fibrillation, Uncontrolled arrhythmias&#xD;
        </textblock>
      </criteria>
      <gender>All</gender>
      <minimum_age>21 Years</minimum_age>
      <maximum_age>105 Years</maximum_age>
      <healthy_volunteers>Accepts Healthy Volunteers</healthy_volunteers>
    </eligibility>
    <overall_official>
      <last_name>Emily K. Pauli, PharmD</last_name>
      <role>Principal Investigator</role>
      <affiliation>Radicle Science, Inc</affiliation>
    </overall_official>
    <overall_contact>
      <last_name>Study Manager</last_name>
      <phone>760-281-3898</phone>
      <email>studymgmt@radiclescience.com</email>
    </overall_contact>
    <location>
      <facility>
        <name>Radicle Science, Inc</name>
        <address>
          <city>Del Mar</city>
          <state>California</state>
          <zip>92014</zip>
          <country>United States</country>
        </address>
      </facility>
      <status>Recruiting</status>
      <contact>
        <last_name>Study Management</last_name>
        <phone>760-281-3898</phone>
        <email>studymgmt@radiclescience.com</email>
      </contact>
    </location>
    <location_countries>
      <country>United States</country>
    </location_countries>
    <link>
      <url>http://radiclescience.com</url>
      <description>Related Info</description>
    </link>
    <verification_date>August 2023</verification_date>
    <study_first_submitted>August 18, 2023</study_first_submitted>
    <study_first_submitted_qc>August 18, 2023</study_first_submitted_qc>
    <study_first_posted type="Actual">August 24, 2023</study_first_posted>
    <last_update_submitted>August 18, 2023</last_update_submitted>
    <last_update_submitted_qc>August 18, 2023</last_update_submitted_qc>
    <last_update_posted type="Actual">August 24, 2023</last_update_posted>
    <responsible_party>
      <responsible_party_type>Sponsor</responsible_party_type>
    </responsible_party>
    <condition_browse>
      <!-- CAUTION:  The following MeSH terms are assigned with an imperfect algorithm            -->
      <mesh_term>Abdominal Pain</mesh_term>
    </condition_browse>
    <patient_data>
      <sharing_ipd>No</sharing_ipd>
      <ipd_description>Data will not be shared with researchers outside of Radicle Collaborators on this study.</ipd_description>
    </patient_data>
    <!-- Results have not yet been posted for this study                                          -->
  </clinical_study>
  
  
text: download date: ClinicalTrials.gov processed this data on September 20, 2023
  link text: Link to the current ClinicalTrials.gov record.
  url: https://clinicaltrials.gov/ct2/show/NCT06009614
  org study id: RADX-2307
  nct id: NCT06009614
  lead sponsor: 
  has dmc: No
  is fda regulated drug: No
  is fda regulated device: No
  A randomized, blinded, placebo-controlled study assessing the impact of health and wellness
        products on gastrointestinal (GI) health and other health outcomes
  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 less bloating or indigestion, (2)
        indicate an interest in taking a health and wellness product to potentially help their
        bloating or indigestion, 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 are collected electronically from eligible participants over 7 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.
  allocation: Randomized
  intervention model: Parallel Assignment
  intervention model description: Participants will be stratified based on gender at birth then randomized to one of the study arms
  primary purpose: Other
  masking: Single (Participant)
  masking description: Participants will be blinded to the product they receive.
  measure: Change in GI (Gastrointestinal) - related Quality of Life (QOL)
  time frame: 6 weeks
  description: Mean difference in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ) (scale 0%-100%; with higher scores corresponding to worse GI-related QOL)
  measure: Change in abdominal pain
  time frame: 6 weeks
  description: Mean difference in abdominal pain as assessed by Patient Reported Outcome Measurement System (PROMIS) Belly Pain 5A (scale 2-25; with higher scores corresponding to more severe abdominal pain)
  measure: Change in gas/bloating
  time frame: 6 weeks
  description: Mean Difference in Gas/Bloating as assessed by PROMIS GI Gas and Bloating 13A (scale 2-60; with higher scores corresponding to more severe gas/bloating)
  measure: Change in feelings of anxiety
  time frame: 6 weeks
  description: Mean difference in anxiety score as assessed by PROMIS Anxiety 4A (scale 4-20; with higher scores corresponding to more severe anxiety)
  measure: Minimal clinically important difference (MCID) in GI-related QOL
  time frame: 6 weeks
  description: Likelihood of experiencing MCID in GI-related QOL as assessed by Digestion-associated QOL Questionnaire (DGLQ)
  measure: Minimal clinically important difference (MCID) in abdominal pain
  time frame: 6 weeks
  description: Likelihood of experiencing MCID in abdominal pain as assessed by PROMIS Belly Pain 5A
  measure: Minimal clinically important difference (MCID) in gas/bloating
  time frame: 6 weeks
  description: Likelihood of experiencing MCID in gas/bloating PROMIS GI Gas and Bloating 13A
  measure: Change in mood (emotional distress-depression)
  time frame: 6 weeks
  description: Mean difference in emotional distress score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)
  measure: Change in libido
  time frame: 6 weeks
  description: Mean difference in libido score as assessed by PROMIS Sexual Interest 2.0 (scale 2-10; with higher scores corresponding to greater interest in sexual activity)
  arm group label: Placebo Control 1
  arm group type: Placebo Comparator
  description: GI Health Product Form 1 - control
  arm group label: Active Product 1.1
  arm group type: Experimental
  description: GI Health Product Form 1 - active product 1
  intervention type: Dietary Supplement
  intervention name: Placebo Control Form 1
  description: Participants will use their Placebo Control Form 1 as directed for a period of 6 weeks.
  arm group label: Placebo Control 1
  intervention type: Dietary Supplement
  intervention name: GI Health Active Study Product 1.1
  description: Participants will use their Radicle GI Health Active Study Product 1.1 as directed for a period of 6 weeks.
  arm group label: Active Product 1.1
  criteria: 
  gender: All
  minimum age: 21 Years
  maximum age: 105 Years
  healthy volunteers: Accepts Healthy Volunteers
  last name: Emily K. Pauli, PharmD
  role: Principal Investigator
  affiliation: Radicle Science, Inc
  last name: Study Manager
  phone: 760-281-3898
  email: studymgmt@radiclescience.com
  facility: 
  status: Recruiting
  contact: 
  country: United States
  url: http://radiclescience.com
  description: Related Info
  responsible party type: Sponsor
  mesh term: Abdominal Pain
  sharing ipd: No
  ipd description: Data will not be shared with researchers outside of Radicle Collaborators on this study.