Ignite Creation Date:
2025-12-24 @ 6:41 PM
Ignite Modification Date:
2026-01-01 @ 2:33 PM
Study NCT ID:
NCT05145257
Status:
COMPLETED
Last Update Posted:
2025-01-01
First Post:
2021-11-23
Is Gene Therapy:
True
Has Adverse Events:
True
Brief Title:
Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms
Sponsor:
Organization:
Raw JSON
{'hasResults': True, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D004412', 'term': 'Dysmenorrhea'}], 'ancestors': [{'id': 'D008599', 'term': 'Menstruation Disturbances'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D017699', 'term': 'Pelvic Pain'}, {'id': 'D010146', 'term': 'Pain'}, {'id': 'D009461', 'term': 'Neurologic Manifestations'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}}, 'resultsSection': {'moreInfoModule': {'pointOfContact': {'email': 'hello@citruslabs.com', 'phone': '4242450284', 'title': 'Patrick Renner', 'organization': 'Citruslabs'}, 'certainAgreement': {'piSponsorEmployee': False, 'restrictiveAgreement': False}}, 'adverseEventsModule': {'timeFrame': 'Adverse event data were collected for the duration of the trial. Each participant was monitored for the 3 months they took part in the trial.', 'description': "All participants were monitored for any untoward or unfavorable medical occurrence in a participant, including any abnormal sign (for example, abnormal physical exam or laboratory finding), symptom, or disease, temporally associated with the participant's participation in the research, whether or not considered related to the participant's participation in the research.", 'eventGroups': [{'id': 'EG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance', 'otherNumAtRisk': 68, 'deathsNumAtRisk': 68, 'otherNumAffected': 7, 'seriousNumAtRisk': 68, 'deathsNumAffected': 0, 'seriousNumAffected': 0}], 'otherEvents': [{'term': 'Stomach upset', 'notes': 'One participant withdrew from the trial due to stomach upset.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Gastrointestinal disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Headache', 'notes': 'One participant withdraw from the trial due to headaches.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'General disorders', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'Personal Issue', 'notes': 'One participant withdrew from the trial due to a personal issue unrelated to the product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 1, 'numAffected': 1}], 'organSystem': 'Social circumstances', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}, {'term': 'No response', 'notes': 'Four participants withdrew from the trial as they reported nil effect or response from the product.', 'stats': [{'groupId': 'EG000', 'numAtRisk': 68, 'numEvents': 4, 'numAffected': 4}], 'organSystem': 'Product Issues', 'assessmentType': 'NON_SYSTEMATIC_ASSESSMENT'}], 'frequencyThreshold': '0'}, 'outcomeMeasuresModule': {'outcomeMeasures': [{'type': 'PRIMARY', 'title': 'Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.41', 'spread': '1.10', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.48', 'spread': '1.18', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '3.12', 'spread': '1.14', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.72', 'spread': '1.09', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '5.00', 'spread': '0.92', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.95', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.24', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '3.02', 'spread': '1.30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'PRIMARY', 'title': 'Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '2.05', 'spread': '0.16', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '1.32', 'spread': '0.06', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '1.07', 'spread': '0.13', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '0.86', 'spread': '0.03', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome.', 'unitOfMeasure': 'NSAID tablets per day', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction in Mood Swings. [Time Frame: Baseline to Week 12]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.59', 'spread': '1.01', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.36', 'spread': '1.19', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '3.15', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.75', 'spread': '1.41', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.36', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.59', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '3.15', 'spread': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.84', 'spread': '1.37', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in anxiety and depression. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.74', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.02', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.51', 'spread': '1.35', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.33', 'spread': '1.31', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in acne flare ups. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Headaches. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.08', 'spread': '1.32', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.92', 'spread': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.64', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.49', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in headaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Backaches. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.15', 'spread': '1.33', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.05', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.62', 'spread': '1.28', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.38', 'spread': '1.48', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in backaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Body Aches. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.67', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.44', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.28', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.08', 'spread': '1.18', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in body aches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Bloating. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.21', 'spread': '1.22', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.21', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.87', 'spread': '1.29', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.51', 'spread': '1.36', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in bloating. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.97', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.05', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.74', 'spread': '1.25', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.26', 'spread': '1.29', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in gastrointestinal issues. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.46', 'spread': '1.52', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.31', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.16', 'spread': '1.05', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '1.90', 'spread': '1.10', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in joint or muscle pain. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '4.69', 'spread': '0.96', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.62', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '3.26', 'spread': '1.39', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.93', 'spread': '1.30', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in tiredness and fatigue. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.49', 'spread': '1.51', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.66', 'spread': '1.40', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.31', 'spread': '1.27', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.08', 'spread': '1.27', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.30', 'spread': '1.41', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '2.62', 'spread': '1.38', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.20', 'spread': '1.30', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '1.93', 'spread': '1.18', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in breast tenderness. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}, {'type': 'SECONDARY', 'title': 'Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]', 'denoms': [{'units': 'Participants', 'counts': [{'value': '61', 'groupId': 'OG000'}]}], 'groups': [{'id': 'OG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'classes': [{'title': 'Baseline', 'categories': [{'measurements': [{'value': '3.98', 'spread': '1.20', 'groupId': 'OG000'}]}]}, {'title': 'Month 1', 'categories': [{'measurements': [{'value': '3.03', 'spread': '1.31', 'groupId': 'OG000'}]}]}, {'title': 'Month 2', 'categories': [{'measurements': [{'value': '2.31', 'spread': '1.21', 'groupId': 'OG000'}]}]}, {'title': 'Month 3', 'categories': [{'measurements': [{'value': '2.16', 'spread': '1.13', 'groupId': 'OG000'}]}]}], 'analyses': [{'pValue': '<0.001', 'groupIds': ['OG000'], 'pValueComment': 'Baseline versus endline comparison.', 'statisticalMethod': 'ANOVA', 'nonInferiorityType': 'OTHER'}], 'paramType': 'MEAN', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in appetite and food cravings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.', 'unitOfMeasure': 'score on a scale', 'dispersionType': 'Standard Deviation', 'reportingStatus': 'POSTED'}]}, 'participantFlowModule': {'groups': [{'id': 'FG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'periods': [{'title': 'Overall Study', 'milestones': [{'type': 'STARTED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '68'}]}, {'type': 'COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '61'}]}, {'type': 'NOT COMPLETED', 'achievements': [{'groupId': 'FG000', 'numSubjects': '7'}]}]}], 'recruitmentDetails': 'Main recruitment took place between 1/5/2022 - 1/10/2022 when 65 participants were recruited. A further 3 participants were recruited on 01/26/2022.'}, 'baselineCharacteristicsModule': {'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'groups': [{'id': 'BG000', 'title': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement\n\nElix Cycle Balance: Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance'}], 'measures': [{'title': 'Age, Continuous', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '31', 'spread': '5.07', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'years', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Sex: Female, Male', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'title': 'Female', 'measurements': [{'value': '68', 'groupId': 'BG000'}]}, {'title': 'Male', 'measurements': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants'}, {'title': 'Race and Ethnicity Not Collected', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '0', 'groupId': 'BG000'}]}]}], 'paramType': 'COUNT_OF_PARTICIPANTS', 'unitOfMeasure': 'Participants', 'populationDescription': 'Race and Ethnicity were not collected from any participant.'}, {'title': 'Survey-based assessment (0-5 scale) of menstrual symptoms', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '4.07', 'spread': '0.49', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'unitOfMeasure': 'units on a scale', 'dispersionType': 'STANDARD_DEVIATION'}, {'title': 'Use of over-the-counter NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms.', 'classes': [{'denoms': [{'units': 'Participants', 'counts': [{'value': '68', 'groupId': 'BG000'}]}], 'categories': [{'measurements': [{'value': '2.17', 'spread': '0.16', 'groupId': 'BG000'}]}]}], 'paramType': 'MEAN', 'description': 'Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome.', 'unitOfMeasure': 'Number of painkillers taken per day', 'dispersionType': 'STANDARD_DEVIATION'}]}}, 'documentSection': {'largeDocumentModule': {'largeDocs': [{'date': '2021-11-09', 'size': 374928, 'label': 'Study Protocol and Statistical Analysis Plan', 'hasIcf': False, 'hasSap': True, 'filename': 'Prot_SAP_000.pdf', 'typeAbbrev': 'Prot_SAP', 'uploadDate': '2024-10-07T12:13', 'hasProtocol': True}, {'date': '2021-10-28', 'size': 243212, 'label': 'Informed Consent Form', 'hasIcf': True, 'hasSap': False, 'filename': 'ICF_001.pdf', 'typeAbbrev': 'ICF', 'uploadDate': '2024-10-07T12:15', 'hasProtocol': False}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE', 'maskingDescription': 'Open-label observational single-group'}, 'primaryPurpose': 'OTHER', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 68}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2022-01-05', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2024-12', 'completionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2024-12-10', 'studyFirstSubmitDate': '2021-11-23', 'resultsFirstSubmitDate': '2024-10-07', 'studyFirstSubmitQcDate': '2021-11-23', 'lastUpdatePostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'resultsFirstSubmitQcDate': '2024-12-10', 'studyFirstPostDateStruct': {'date': '2021-12-06', 'type': 'ACTUAL'}, 'resultsFirstPostDateStruct': {'date': '2025-01-01', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-05-31', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Relief From Premenstrual Cramps [Time Frame: Baseline to 3 Months]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in premenstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Menstrual Cramps During the Period [Time Frame: Baseline to 3 Months]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in menstrual cramps. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Reduction in Usage of OTC NSAIDS in the Treatment of Primary Dysmenorrhea Symptoms. [Time Frame: Baseline to 3 Months]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment to assess the change in the number of over-the-counter NSAIDS used from baseline to 12 weeks. Participants were presented with the following options: 1 a day, 2 a day, 3 a day, 4+ a day. A lower score indicates a better outcome.'}], 'secondaryOutcomes': [{'measure': 'Reduction in Mood Swings. [Time Frame: Baseline to Week 12]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Feelings of Anxiety and Depression. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in anxiety and depression. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Acne Flare-ups. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in acne flare ups. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Headaches. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in headaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Backaches. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in backaches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Body Aches. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in body aches. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Bloating. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in bloating. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Gastrointestinal Issues. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in gastrointestinal issues. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Joint or Muscle Pain. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in joint or muscle pain. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Tiredness or Fatigue. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in tiredness and fatigue. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Reduction in Weight Gain Due to Fluid Retention. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in menstrual symptoms, fatigue, and mood swings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Relief From Breast Tenderness. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in breast tenderness. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}, {'measure': 'Changes in Appetite and Food Cravings. [Time Frame: Baseline to Month 3]', 'timeFrame': 'Baseline, Month 1, Month 2, Month 3', 'description': 'Survey-based assessment (0-5 scale) of changes in appetite and food cravings. On the scale, 0 = "No symptoms" and 5 = "Severe It interferes with my daily life, and I cancel activities". Lower scores indicate a favourable outcome.'}]}, 'oversightModule': {'oversightHasDmc': False, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['PMS', 'Menstrual Pain']}, 'descriptionModule': {'briefSummary': 'This is an open-label observational single-group clinical trial to study the efficacy of a commercially available dietary supplement and its effect on common PMS and menstrual symptoms.\n\nIt is hypothesized that the dietary supplement marketed as "Elix Cycle Balance" will improve subjective wellbeing in trial participants by alleviating common symptoms of PMS and menstrual symptoms, such as cramps, bloating, and mood swings.\n\nA total of 65 participants will be recruited for the trial following screening, with the expectation that at least 50 participants will complete the trial. The trial will be fully remote, a technology platform will be utilized to screen, enroll and capture study data of the participants. The total intervention study period will be 3 months.'}, 'eligibilityModule': {'sex': 'FEMALE', 'stdAges': ['ADULT'], 'maximumAge': '36 Years', 'minimumAge': '18 Years', 'genderBased': True, 'healthyVolunteers': True, 'eligibilityCriteria': "Inclusion Criteria:\n\n* Female aged 18-36\n* Self-reported moderate to severe discomfort during menstruation, related to pelvic cramps, bloating, mood swings, or fatigue\n* May experience regular or irregular menstrual cycle\n* May be on birth control\n* Must know or can estimate the date of the next cycle/period\n* May find blood clots in menstrual blood\n* Must be in good health (doesn't report any medical conditions asked in the screening questionnaire)\n* Following a stable, consistent diet regimen\n* Follow a stable, consistent exercise regimen and are willing, for the duration of the study, to not decrease or increase the amount of exercise in their regimen\n* Agree to refrain from any lifestyle changes that may affect their menstrual cycle for the duration of the study (for example, getting on or off hormonal birth control, reducing the amount of exercise)\n* Follow a stable consistent regimen when using any other interventions, such as massage, chiropractic medicine, or acupuncture; agree not to increase or decrease the number of their other interventions\n* Willingness to adhere to the dietary supplement regimen\n* Willingness to refrain from any other dietary supplements targeting the menstrual cycle during the study period\n* Is able to communicate in English\n* Is willing and able to share feedback via the used technology portal\n* Must provide written informed consent (ICF)\n\nExclusion Criteria:\n\n* Don't experience a menstrual cycle\n* Can't estimate the onset of their next menstrual cycle\n* Don't experience menstrual cramping\n* Follow an extreme diet intervention\n* Experienced severe weight loss in the past 3 months prior to study participation\n* Usage of any medication or herbal remedies/supplements which can affect the menstrual cycle\n* If currently taking allowed supplements, the dosage needs to remain the same throughout the entirety of the study\n* Food intolerances/allergies that require an EpiPen\n* Known allergic reaction to any of the test product ingredients\n* Currently pregnant, want to become pregnant for the duration of the study, or who are breastfeeding\n* Previous users of Elix Cycle Balance\n* Having more than 3 alcoholic drinks a day\n* Have been diagnosed with the following conditions: PCOS, Endometriosis, PMDD, Adenomyosis, Hashimoto's, anorexia, bulimia, orthorexia, binge eating, any other eating disorder\n* Smokers\n* Not been on a stable dose of birth control for the past 6 months"}, 'identificationModule': {'nctId': 'NCT05145257', 'briefTitle': "Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms", 'organization': {'class': 'INDUSTRY', 'fullName': 'Zenchi, Inc.'}, 'officialTitle': "Study to Evaluate the Efficacy of Elix's Cycle Balance and Its Impact on PMS and Menstrual Symptoms", 'orgStudyIdInfo': {'id': '20239Elix'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'OTHER', 'label': 'Elix Cycle Balance', 'description': 'Elix Cycle Balance supplement', 'interventionNames': ['Dietary Supplement: Elix Cycle Balance']}], 'interventions': [{'name': 'Elix Cycle Balance', 'type': 'DIETARY_SUPPLEMENT', 'description': 'Each day in the morning and at night in the week prior to the menstruation, the participants will take 6 full droppers of Elix Cycle Balance', 'armGroupLabels': ['Elix Cycle Balance']}]}, 'contactsLocationsModule': {'locations': [{'zip': '90404', 'city': 'Santa Monica', 'state': 'California', 'country': 'United States', 'facility': 'Citruslabs', 'geoPoint': {'lat': 34.01949, 'lon': -118.49138}}], 'overallOfficials': [{'name': 'Susanne Mitschke, MSc', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'Citruslabs'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'UNDECIDED'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Zenchi, Inc.', 'class': 'INDUSTRY'}, 'collaborators': [{'name': 'Citruslabs', 'class': 'INDUSTRY'}], 'responsibleParty': {'type': 'SPONSOR'}}}}