Ignite Creation Date:
2025-12-26 @ 10:36 AM
Ignite Modification Date:
2025-12-29 @ 2:12 PM
Study NCT ID:
NCT07219628
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-10-22
First Post:
2025-09-22
Is Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Radicle Calm RDH: A Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D001008', 'term': 'Anxiety Disorders'}], 'ancestors': [{'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR'], 'maskingDescription': "The investigator is blinded to the participants' assigned study products. Participants are blinded to the study product they received."}, 'primaryPurpose': 'OTHER', 'interventionModel': 'PARALLEL', 'interventionModelDescription': 'Participants will be stratified based on their assigned sex at birth and health outcome score during enrollment, then randomized to one of the study arms. Each participant will have an equal chance of being assigned to any study arm.'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 550}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2025-09-23', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-09', 'completionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-10-20', 'studyFirstSubmitDate': '2025-09-22', 'studyFirstSubmitQcDate': '2025-10-20', 'lastUpdatePostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2025-10-22', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2026-09-23', 'type': 'ESTIMATED'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Minimal clinically important difference (MCID) in feelings of stress', 'timeFrame': '7 weeks', 'description': 'Minimal clinically important difference (MCID) in feelings of stress: Likelihood of experiencing minimal clinically important difference in feelings of stress as assessed by Perceived Stress Scale (PSS-4) (scale 0-16; where lower scores correspond to less stress)'}, {'measure': 'Minimal clinically important difference (MCID) in sleep', 'timeFrame': '7 weeks', 'description': 'Minimal clinically important difference (MCID) in sleep: Likelihood of experiencing minimal clinically important difference in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)'}, {'measure': 'Minimal clinically important difference (MCID) in mood (emotional distress-depression)', 'timeFrame': '7 weeks', 'description': 'Minimal clinically important difference (MCID) in mood (emotional distress-depression): Likelihood of experiencing minimal clinically important difference in mood score as assessed by PROMIS Emotional Distress- Depression 4A (scale 4-20; with higher scores corresponding to greater levels of emotional distress)'}, {'measure': 'Minimal clinically important difference (MCID) in feelings of anxiety', 'timeFrame': '7 weeks', 'description': 'Minimal clinically important difference (MCID) in feelings of anxiety: Likelihood of experiencing minimal clinically important difference in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to greater feelings of anxiety)'}], 'primaryOutcomes': [{'measure': 'Change in feelings of anxiety', 'timeFrame': '7 weeks', 'description': 'Change in feelings of anxiety: Difference between rates of change over time in feelings of anxiety score as assessed by PROMIS Anxiety 8A (scale 8-40; with higher scores corresponding to more severe anxiety)'}], 'secondaryOutcomes': [{'measure': 'Change in feelings of stress', 'timeFrame': '7 weeks', 'description': 'Change in feelings of stress: Difference between rates of change over time in feelings of stress score as assessed Perceived Stress Scale 4 (PSS-4) (scale 0-16; where lower scores correspond to less stress)'}, {'measure': 'Change in sleep', 'timeFrame': '7 weeks', 'description': 'Change in sleep: Difference in rates of change over time in sleep score as assessed by PROMIS Sleep Disturbance 8A (scale 8-40; where higher scores correspond to higher levels of sleep disturbance)'}, {'measure': 'Change in mood (emotional distress-depression)', 'timeFrame': '7 weeks', 'description': 'Change in mood (emotional distress-depression): Difference in rates of change over time in emotional distress score as assessed by PROMIS Emotional Distress- Depression 8A (scale 8-40; with higher scores corresponding to greater levels of emotional distress)'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Anxiety']}, 'referencesModule': {'seeAlsoLinks': [{'url': 'https://www.radiclescience.com', 'label': 'Related Info'}]}, 'descriptionModule': {'briefSummary': 'A randomized, double-blind, placebo-controlled direct-to-consumer study assessing the impact of health and wellness products on feelings of anxiety and related health outcomes.', 'detailedDescription': 'This is a randomized, double-blind, placebo-controlled study conducted with adult participants, residing in the United States.\n\nEligible participants will (1) have the opportunity for meaningful improvement (at least 30%) in their primary health outcome and (2) express acceptance in taking a product and not knowing its formulation until the end of the study.\n\nParticipants 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.\n\nSelf-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.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '105 Years', 'minimumAge': '21 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Participants must meet all the following criteria:\n\n* Adults, at least 21 years of age at the time of electronic consent, inclusive of all ethnicities, races, and gender identities.\n\n * Assigned sex at birth will determine sex-specific recruitment and surveys (male vs female) employed, when needed.\n* Resides in the United States.\n* Has the opportunity for at least 30% improvement in their primary health outcome.\n* Expresses a willingness to take a study product and not know the product identity (active or placebo) until the end of the study.\n\nIndividuals who report any of the following during screening will be excluded from participation:\n\n* Report being pregnant, trying to become pregnant, or breastfeeding.\n* Unable to provide a valid US shipping address and mobile phone number\n* Reports current enrollment in another clinical trial.\n* Reports being a heavy drinker (defined as drinking 3 or more alcoholic beverages per day).\n* Unable to read and understand English.\n* Reports a current and/or recent (up to 3 months ago) major illness and/or surgery that poses a known, significant safety risk.\n* 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.\n\n * NYHA Class III or IV congestive heart failure, atrial fibrillation, uncontrolled arrhythmias, cirrhosis, end-stage liver disease, stage 3b or 4 chronic kidney disease, or kidney failure.\n* Reports taking medications that have a well-established moderate or severe interaction, posing a substantial safety risk with any of the study product ingredients.\n\n * 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, MAOIs, or thyroid products.\n* 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 products.\n* Lack of reliable daily access to the internet.'}, 'identificationModule': {'nctId': 'NCT07219628', 'briefTitle': 'Radicle Calm RDH: A Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes', 'organization': {'class': 'INDUSTRY', 'fullName': 'Radicle Science'}, 'officialTitle': 'Radicle Calm RDH: A Randomized, Double-Blind, Placebo-Controlled Direct-to-Consumer Study Assessing the Impact of Health and Wellness Products on Feelings of Anxiety and Related Health Outcomes', 'orgStudyIdInfo': {'id': 'RADX_P_2402_RDH'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Control', 'description': 'Calm Product Placebo Control', 'interventionNames': ['Dietary Supplement: Calm Product Placebo Control']}, {'type': 'EXPERIMENTAL', 'label': 'Active Product 1', 'description': 'Calm Active Product 1', 'interventionNames': ['Dietary Supplement: Calm Active Product 1']}], 'interventions': [{'name': 'Calm Product Placebo Control', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their Calm Product Placebo Control as directed for a period of 6 weeks.', 'armGroupLabels': ['Placebo Control']}, {'name': 'Calm Active Product 1', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Participants will use their Calm Active Product 1 as directed for a period of 6 weeks.', 'armGroupLabels': ['Active Product 1']}]}, 'contactsLocationsModule': {'locations': [{'zip': '92014', 'city': 'Del Mar', 'state': 'California', 'country': 'United States', 'facility': 'Radicle Science Inc.', 'geoPoint': {'lat': 32.95949, 'lon': -117.26531}}], 'overallOfficials': [{'name': 'Susan Hewlings', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Radicle Science'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Data will not be shared with researchers outside of Radicle Collaborators on this study.'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Radicle Science', 'class': 'INDUSTRY'}, 'responsibleParty': {'type': 'SPONSOR'}}}}