Ignite Creation Date:
2025-12-25 @ 2:22 AM
Ignite Modification Date:
2025-12-27 @ 11:44 PM
Study NCT ID:
NCT06762834
Status:
ACTIVE_NOT_RECRUITING
Last Update Posted:
2025-01-08
First Post:
2024-12-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Investigating the Role of Ginger Tea ORAC Value in Hypertension Management
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D006973', 'term': 'Hypertension'}], 'ancestors': [{'id': 'D014652', 'term': 'Vascular Diseases'}, {'id': 'D002318', 'term': 'Cardiovascular Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'HEALTH_SERVICES_RESEARCH', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ACTUAL', 'count': 50}}, 'statusModule': {'overallStatus': 'ACTIVE_NOT_RECRUITING', 'startDateStruct': {'date': '2024-03-01', 'type': 'ACTUAL'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2025-01', 'completionDateStruct': {'date': '2025-03-01', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2025-01-06', 'studyFirstSubmitDate': '2024-12-17', 'studyFirstSubmitQcDate': '2025-01-06', 'lastUpdatePostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2025-01-08', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2024-10-01', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Systolic Blood Pressure (SBP)', 'timeFrame': '12 Months', 'description': 'Measure changes in SBP before and after the intervention with ginger tea over a defined period.'}, {'measure': 'Total ORAC Value', 'timeFrame': '12 Months', 'description': 'Measure the total Oxygen Radical Absorbance Capacity (ORAC) value of ginger tea consumed by participants to evaluate its antioxidant capacity and potential correlation with blood pressure changes.'}, {'measure': 'Diastolic Blood Pressure (DBP)', 'timeFrame': '12 months', 'description': 'Measure changes in DBP before and after the intervention with ginger tea over a defined period.'}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'conditions': ['Hypertension']}, 'descriptionModule': {'briefSummary': 'The purpose of this study is to evaluate the antihypertensive effects of ginger tea. By examining its impact on blood pressure levels, this research aims to determine whether ginger tea can be an effective, natural adjunct to conventional hypertension treatments.', 'detailedDescription': 'This investigation will provide insights into its potential role in reducing the burden of hypertension and improving cardiovascular health'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '30 Years', 'healthyVolunteers': True, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Adults aged 30-65 years\n* Diagnosed with stage 1 or stage 2 hypertension\n* Not currently taking antihypertensive medication\n* Willing to provide informed consent and adhere to study protocols.\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding women\n* Participants on antioxidant supplements or other herbal teas.'}, 'identificationModule': {'nctId': 'NCT06762834', 'briefTitle': 'Investigating the Role of Ginger Tea ORAC Value in Hypertension Management', 'organization': {'class': 'OTHER', 'fullName': 'Superior University'}, 'officialTitle': 'Investigating the Role of Ginger Tea ORAC Value in Hypertension Management', 'orgStudyIdInfo': {'id': 'MSAHS/Batch-Spring23/023'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'Ginger Tea', 'interventionNames': ['Combination Product: Ginger tea']}, {'type': 'ACTIVE_COMPARATOR', 'label': 'Self Administered Tea', 'interventionNames': ['Combination Product: self administred Ginger tea']}], 'interventions': [{'name': 'Ginger tea', 'type': 'COMBINATION_PRODUCT', 'description': 'determine the optimal dosage of ginger tea that produces significant blood pressure reduction without adverse effects.', 'armGroupLabels': ['Ginger Tea']}, {'name': 'self administred Ginger tea', 'type': 'COMBINATION_PRODUCT', 'description': 'To identify consumption and its correlation with blood pressure outcomes using a self- reported diary and periodic clinical assessments.', 'armGroupLabels': ['Self Administered Tea']}]}, 'contactsLocationsModule': {'locations': [{'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Azra Naheed Medical College, Superior University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}, {'city': 'Lahore', 'state': 'Punjab Province', 'country': 'Pakistan', 'facility': 'Chaudary Muhammad Akram Teaching Hospital, Azra Naheed Medical College, Superior University', 'geoPoint': {'lat': 31.558, 'lon': 74.35071}}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Superior University', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'Principal Investigator', 'investigatorFullName': 'Muhammad Naveed Babur', 'investigatorAffiliation': 'Superior University'}}}}