Ignite Creation Date:
2025-12-24 @ 9:14 PM
Ignite Modification Date:
2025-12-25 @ 7:03 PM
Study NCT ID:
NCT06136104
Status:
COMPLETED
Last Update Posted:
2024-05-08
First Post:
2023-10-27
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D065446', 'term': 'Premenstrual Dysphoric Disorder'}, {'id': 'D011293', 'term': 'Premenstrual Syndrome'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D003866', 'term': 'Depressive Disorder'}, {'id': 'D019964', 'term': 'Mood Disorders'}, {'id': 'D001523', 'term': 'Mental Disorders'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'TRIPLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR', 'OUTCOMES_ASSESSOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 100}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-08-30', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2023-11', 'completionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-05-07', 'studyFirstSubmitDate': '2023-10-27', 'studyFirstSubmitQcDate': '2023-11-15', 'lastUpdatePostDateStruct': {'date': '2024-05-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-11-18', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2023-12-20', 'type': 'ACTUAL'}}, 'outcomesModule': {'otherOutcomes': [{'measure': 'Other miscellaneous changes noticed during menstrual bleeding', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey free response prompt'}], 'primaryOutcomes': [{'measure': 'Menstrual Cramping and/or Back Pain', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Mood Regulation', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 mood scale'}, {'measure': 'Bloating', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Menstrual Bleeding Volume', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 scale of flow volume'}, {'measure': 'Menstrual Bleeding Duration', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey recording start and end day of menstrual bleeding'}], 'secondaryOutcomes': [{'measure': 'Fatigue', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 scale of fatigue experienced'}, {'measure': 'Acne', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Difficulty Concentrating', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Overeating/Food Cravings', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Insomnia', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Hypersomnia', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey 1-10 severity scale'}, {'measure': 'Period symptom interference with school/work efficiency/productivity', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey four-point Likert scale'}, {'measure': 'Period symptom interference with social life activities', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey four-point Likert scale'}, {'measure': 'Period symptom interference with physical activity (sports, gym, or daily performance)', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey four-point Likert scale'}, {'measure': 'Any positive or negative mood changes noticed during period', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey free response prompt'}, {'measure': 'Any positive or negative mood changes noticed during other weeks of the menstrual cycle not bleeding', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey free response prompt'}, {'measure': 'Non-steroidal anti-inflammatory drug use for acute symptoms during menstrual bleeding', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey free response prompt'}, {'measure': 'Number of pads/tampons/other products used during menstrual bleeding', 'timeFrame': '120 days', 'description': 'Measured through post-menstrual bleeding electronic survey free response prompt'}]}, 'oversightModule': {'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['PMS (Premenstrual syndrome)', 'PMDD (Premenstrual dysphoric disorder)', 'Period Symptoms', 'Menstrual Cycle', 'Menstrual Cramping', 'Menstrual Bleeding'], 'conditions': ['Healthy', 'Premenstrual Dysphoric Disorder', 'Premenstrual Syndrome']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to assess Mixhers HERTIME supplements efficacy in alleviating menstrual cycle symptoms.', 'detailedDescription': 'All participants, after providing written informed consent, will drink a daily self-administered powder-mix supplement in water of either placebo or Mixhers HERTIME for 120 consecutive days. Surveys will be administered electronically to each participant in the first month to assess baseline menstrual cycle symptoms. In addition, before starting the supplement, participants will take the electronic survey "The Premenstrual Symptoms Screening Tool". During the first month of taking the supplement, participants will take an allergy and constitutional symptom survey electronically to assess for any adverse reactions to the product. Each month for four months, participants will complete an electronic survey assessing menstrual cycle symptoms after a menstrual cycle is completed.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '45 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Must be biologically female, must have a regular menstrual cycle (defined as a menstrual bleed every 23-35 days), must be a student, staff, or faculty member at Midwestern University Glendale, Arizona campus\n\nExclusion Criteria:\n\n* not pregnant or planning to become pregnant, must not be on anticoagulants, must not have allergies to lemon or stevia'}, 'identificationModule': {'nctId': 'NCT06136104', 'briefTitle': 'The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms', 'organization': {'class': 'OTHER', 'fullName': 'Midwestern University'}, 'officialTitle': 'The Effects of Mixhers HERTIME Supplements on Menstrual Symptoms', 'orgStudyIdInfo': {'id': '23007'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Mixhers HERTIME', 'description': '1 daily powder stick packet (3.0-3.3 g) of Mixhers HERTIME herbal supplement mixed into water', 'interventionNames': ['Dietary Supplement: Mixhers HERTIME']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo', 'description': '1 daily powder stick packet (3 g) of a matching placebo powder supplement mixed into water', 'interventionNames': ['Dietary Supplement: Placebo']}], 'interventions': [{'name': 'Mixhers HERTIME', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily self-administered powder supplement packet mixed into water.', 'armGroupLabels': ['Mixhers HERTIME']}, {'name': 'Placebo', 'type': 'DIETARY_SUPPLEMENT', 'description': 'A daily self-administered powder placebo supplement packet mixed into water.', 'armGroupLabels': ['Placebo']}]}, 'contactsLocationsModule': {'locations': [{'zip': '85308', 'city': 'Glendale', 'state': 'Arizona', 'country': 'United States', 'facility': 'Midwestern University', 'geoPoint': {'lat': 33.53865, 'lon': -112.18599}}], 'overallOfficials': [{'name': 'Farshad Agahi, MD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Midwestern University- Glendale, AZ'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Midwestern University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}