Ignite Creation Date:
2025-12-24 @ 9:27 PM
Ignite Modification Date:
2025-12-25 @ 7:12 PM
Study NCT ID:
NCT06158932
Status:
COMPLETED
Last Update Posted:
2024-04-03
First Post:
2023-11-28
Is NOT Gene Therapy:
False
Has Adverse Events:
False
Brief Title:
A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D011085', 'term': 'Polycystic Ovary Syndrome'}], 'ancestors': [{'id': 'D010048', 'term': 'Ovarian Cysts'}, {'id': 'D003560', 'term': 'Cysts'}, {'id': 'D009369', 'term': 'Neoplasms'}, {'id': 'D010049', 'term': 'Ovarian Diseases'}, {'id': 'D000291', 'term': 'Adnexal Diseases'}, {'id': 'D005831', 'term': 'Genital Diseases, Female'}, {'id': 'D052776', 'term': 'Female Urogenital Diseases'}, {'id': 'D005261', 'term': 'Female Urogenital Diseases and Pregnancy Complications'}, {'id': 'D000091642', 'term': 'Urogenital Diseases'}, {'id': 'D000091662', 'term': 'Genital Diseases'}, {'id': 'D006058', 'term': 'Gonadal Disorders'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D005492', 'term': 'Folic Acid'}], 'ancestors': [{'id': 'D011622', 'term': 'Pterins'}, {'id': 'D011621', 'term': 'Pteridines'}, {'id': 'D006574', 'term': 'Heterocyclic Compounds, 2-Ring'}, {'id': 'D000072471', 'term': 'Heterocyclic Compounds, Fused-Ring'}, {'id': 'D006571', 'term': 'Heterocyclic Compounds'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 40}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2023-09-08', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-04', 'completionDateStruct': {'date': '2024-01-06', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-04-01', 'studyFirstSubmitDate': '2023-11-28', 'studyFirstSubmitQcDate': '2023-11-28', 'lastUpdatePostDateStruct': {'date': '2024-04-03', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2023-12-06', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-01-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Changes in menstrual cycle regularity. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires with participants reporting menstrual cycle occurrence and regularity during the trial.'}, {'measure': 'Changes in severity of menstrual cramps. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}, {'measure': 'Changes in hormonal skin issues. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}, {'measure': 'Changes in excessive body hair or facial hair. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}], 'secondaryOutcomes': [{'measure': 'Changes in mood. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}, {'measure': 'Changes in stress. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}, {'measure': 'Changes in food cravings. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}, {'measure': 'Changes in sleep quality. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}, {'measure': 'Changes in energy. [Timeframe: Baseline to Week 12]', 'timeFrame': '12 weeks', 'description': 'Measured via study-specific questionnaires using a 5-point Likert scale. A lower score indicates a more favourable response, with 0=Not noticeable and 4=Severe.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Polycystic Ovary Syndrome', 'Hormone Imbalance']}, 'descriptionModule': {'briefSummary': 'This is a virtual single group study that will last 12 weeks. 40 female participants will take 4 capsules of the Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement per day. Questionnaires will be completed at Baseline, Week 4, Week 8 and Week 12. Participants will also provide a waist circumference measurement at Baseline and Week 12.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '55 Years', 'minimumAge': '18 Years', 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Women aged between 18 - 55\n* BMI less than 35\n* Self-reported symptoms of PCOS like irregular periods, excessive hair growth, weight gain, oily skin, or acne\n* Self-reported concerns around irregular menstrual cycles and ovulation, mood swings, stress, irritability, and low energy\n* Self-reported concerns with hormonal skin issues\n* Has access to a tape measure for waist measurement\n* Generally healthy - don't live with any uncontrolled chronic disease\n\nExclusion Criteria:\n\n* Anyone with pre-existing chronic conditions that would prevent participants from adhering to the protocol, including oncological and psychiatric disorders\n* Anyone with known severe allergic reactions\n* Anyone who is pregnant or breastfeeding\n* Unwilling to follow the study protocol"}, 'identificationModule': {'nctId': 'NCT06158932', 'briefTitle': 'A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance', 'organization': {'class': 'OTHER', 'fullName': 'Optify'}, 'officialTitle': 'A Single Group Study to Evaluate the Effects of a Myo-Inositol and D-Chiro Inositol Supplement on Symptoms Associated With Polycystic Ovary Syndrome and Hormone Imbalance', 'orgStudyIdInfo': {'id': '20366'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Myo Inositol and D-Chiro Inositol Supplement', 'description': 'Participants must take 4 capsules per day, with water. The product should be taken with the last meal of the day.', 'interventionNames': ['Dietary Supplement: Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement']}], 'interventions': [{'name': 'Optify Myo Inositol and D-Chiro Inositol Plus Folate and Vitamin D supplement', 'type': 'DIETARY_SUPPLEMENT', 'description': 'This product contains Myo-Inositol, D-Chiro-Inositol, Folate and Vitamin D.', 'armGroupLabels': ['Myo Inositol and D-Chiro Inositol Supplement']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Optify', 'class': 'OTHER'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}