Ignite Creation Date:
2025-12-24 @ 5:35 PM
Ignite Modification Date:
2025-12-27 @ 8:17 AM
Study NCT ID:
NCT06939868
Status:
NOT_YET_RECRUITING
Last Update Posted:
2025-04-23
First Post:
2025-04-11
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D019584', 'term': 'Hot Flashes'}], 'ancestors': [{'id': 'D012816', 'term': 'Signs and Symptoms'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 44}}, 'statusModule': {'overallStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2025-05-01', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-04', 'completionDateStruct': {'date': '2025-09-30', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-04-18', 'studyFirstSubmitDate': '2025-04-11', 'studyFirstSubmitQcDate': '2025-04-18', 'lastUpdatePostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-04-23', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2025-08-30', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Composite hot flash score: Frequency × Severity', 'timeFrame': '30 days', 'description': 'Frequency: Total number of hot flashes experienced that day. Hot Flash Severity: Rating of hot flashes on a 7-point severity scale (0 = none, 1 = very mild, 2 = mild, 3 = mild/moderate, 4 = moderate, 5 = severe, 6 = very severe)'}], 'secondaryOutcomes': [{'measure': 'Menopause Rating Scale', 'timeFrame': '30 days', 'description': 'Validated self-administered questionnaire consisting of 11 items that assesses menopausal symptoms. Each item is rated on a 5-point Likert scale from 0 (not present) to 4 (very severe), yielding a total score range of 0 to 44, with higher scores indicating more severe symptoms. The Menopause Rating Scale is divided into three domains: somatic (hot flashes, heart discomfort, sleep problems, joint and muscular discomfort), psychological (depressive mood, irritability, anxiety, physical and mental exhaustion), and urogenital (sexual problems, bladder problems, vaginal dryness). This scale has been widely used in clinical research to quantify menopausal symptom burden and its impact on quality of life.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['menopause', 'hot flashes', 'supplement'], 'conditions': ['D008593']}, 'descriptionModule': {'briefSummary': 'The goal of this clinical trial is to learn if a daily nutritional supplement can reduce hot flashes and other menopausal symptoms in postmenopausal women.\n\nThe main questions this study aims to answer are:\n\nDoes the supplement reduce the number and severity of daily hot flashes?\n\nDoes it improve other common menopausal symptoms?\n\nResearchers will compare the supplement to a placebo (a look-alike capsule with no active ingredients) to see if it helps manage symptoms during menopause.\n\nParticipants will:\n\nTake either the supplement or a placebo daily for 30 days\n\nTrack their hot flashes each day using a short online survey\n\nComplete a symptom questionnaire at the beginning and end of the study\n\nThis study is for women ages 40-60 who have been postmenopausal for at least one year and currently experience bothersome hot flashes.', 'detailedDescription': 'Purpose:\n\nTo evaluate the effectiveness of a nutritional supplement in reducing hot flash severity/frequency and menopausal symptoms in postmenopausal women.\n\nDesign:\n\nRandomized, double-blind, placebo-controlled, two-arm, parallel-group trial over 30 days.\n\nParticipants:\n\nWomen aged 40-60 who are postmenopausal (≥1 year without menses) and report bothersome hot flashes (Menopause Rating Scale score ≥14, and hot flash severity of 3 or 4).\n\nExclusion Criteria:\n\nCurrent hormone therapy or medications affecting hot flashes; significant comorbidities.\n\nIntervention:\n\nGroup 1: Placebo\n\nGroup 2: Supplement\n\nAssessments:\n\nDaily self-reports of hot flash frequency/severity\n\nMenopausal symptom assessments at baseline (Day 0) and post-intervention (Day 30)\n\nOutcomes:\n\nPrimary: Hot flash severity and frequency\n\nSecondary: Overall menopausal symptoms'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '60 Years', 'minimumAge': '40 Years', 'genderBased': True, 'genderDescription': 'Female', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adult women aged 40-60 years.\n* Menopause Rating Scale score: (a) GE 14 and (b) score of 3 or 4 (severe to very severe) for hot flashes (Blumel et al., 2018).\n\nExclusion Criteria:\n\n* Current use of hormone therapy or other medications known to affect hot flashes.\n* Significant comorbidities that may interfere with study participation.'}, 'identificationModule': {'nctId': 'NCT06939868', 'briefTitle': 'Effect of a Cepham Supplement on Hot Flashes and Menopausal Symptoms in Postmenopausal Women', 'organization': {'class': 'OTHER', 'fullName': 'Jacksonville University'}, 'officialTitle': "Effectiveness of 'Cepham Supplement' on Hot Flash Severity/Frequency and Menopausal Symptoms in Postmenopausal Women: A Randomized Double-Blind Placebo-Controlled Trial", 'orgStudyIdInfo': {'id': 'SterlingIRB2025'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'ACTIVE_COMPARATOR', 'label': 'Supplement Group', 'interventionNames': ['Dietary Supplement: Shatavari Root Extract, oral capsule']}, {'type': 'PLACEBO_COMPARATOR', 'label': 'Placebo Group: Sugar pill', 'interventionNames': ['Dietary Supplement: Shatavari Root Extract, oral capsule']}], 'interventions': [{'name': 'Shatavari Root Extract, oral capsule', 'type': 'DIETARY_SUPPLEMENT', 'description': "This intervention consists of a proprietary, standardized extract of Asparagus racemosus (Shatavari), formulated specifically for women's health and cognitive support. The supplement is provided in oral capsule form and standardized to a specific concentration of shatavarin IV, the primary active compound. Participants will take one capsule daily for 30 days.\n\nThis formulation, known as SheVari4™, is patent-pending and manufactured by Cepham, designed to address vasomotor symptoms (hot flashes) and other menopausal concerns. It is distinct from other Shatavari supplements in its standardization and use in a placebo-controlled, double-blind trial targeting postmenopausal women.", 'armGroupLabels': ['Placebo Group: Sugar pill', 'Supplement Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '32211', 'city': 'Jacksonville', 'state': 'Florida', 'country': 'United States', 'contacts': [{'name': 'Heather A Hausenblas, PhD', 'role': 'CONTACT', 'email': 'hhausen@ju.edu', 'phone': '904-891-9746'}, {'name': 'Stephanie L Hooper, MPH', 'role': 'CONTACT', 'email': 's.hooper@unf.edu', 'phone': '908-868-8740'}], 'facility': 'Jacksonville University', 'geoPoint': {'lat': 30.33218, 'lon': -81.65565}}], 'centralContacts': [{'name': 'Heather A Hausenblas, PhD', 'role': 'CONTACT', 'email': 'hhausen@ju.edu', 'phone': '904-891-9746'}, {'name': 'Stephanie L Hooper, MPH', 'role': 'CONTACT', 'email': 's.hooper@unf.edu', 'phone': '908-868-8740'}], 'overallOfficials': [{'name': 'Heather A Hausenblas, PhD', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Jacksonville University'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Jacksonville University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}