Ignite Creation Date:
2025-12-25 @ 12:30 AM
Ignite Modification Date:
2026-01-01 @ 9:11 AM
Study NCT ID:
NCT05407467
Status:
UNKNOWN
Last Update Posted:
2022-06-07
First Post:
2022-05-18
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
KurCoSmart Effects on People With Type 2 DM
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}, {'id': 'D007333', 'term': 'Insulin Resistance'}, {'id': 'D007249', 'term': 'Inflammation'}, {'id': 'D001835', 'term': 'Body Weight'}, {'id': 'D003920', 'term': 'Diabetes Mellitus'}], 'ancestors': [{'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}, {'id': 'D006946', 'term': 'Hyperinsulinism'}, {'id': 'D010335', 'term': 'Pathologic Processes'}, {'id': 'D013568', 'term': 'Pathological Conditions, Signs and Symptoms'}, {'id': 'D012816', 'term': 'Signs and Symptoms'}]}, 'interventionBrowseModule': {'meshes': [{'id': 'D003474', 'term': 'Curcumin'}], 'ancestors': [{'id': 'D036381', 'term': 'Diarylheptanoids'}, {'id': 'D006536', 'term': 'Heptanes'}, {'id': 'D000473', 'term': 'Alkanes'}, {'id': 'D006839', 'term': 'Hydrocarbons, Acyclic'}, {'id': 'D006838', 'term': 'Hydrocarbons'}, {'id': 'D009930', 'term': 'Organic Chemicals'}, {'id': 'D002396', 'term': 'Catechols'}, {'id': 'D010636', 'term': 'Phenols'}, {'id': 'D001555', 'term': 'Benzene Derivatives'}, {'id': 'D006841', 'term': 'Hydrocarbons, Aromatic'}, {'id': 'D006844', 'term': 'Hydrocarbons, Cyclic'}]}}, 'protocolSection': {'designModule': {'phases': ['PHASE1', 'PHASE2'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'DOUBLE', 'whoMasked': ['PARTICIPANT', 'INVESTIGATOR']}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 40}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'NOT_YET_RECRUITING', 'startDateStruct': {'date': '2022-06', 'type': 'ESTIMATED'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2022-06', 'completionDateStruct': {'date': '2022-09', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2022-06-01', 'studyFirstSubmitDate': '2022-05-18', 'studyFirstSubmitQcDate': '2022-06-01', 'lastUpdatePostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'studyFirstPostDateStruct': {'date': '2022-06-07', 'type': 'ACTUAL'}, 'primaryCompletionDateStruct': {'date': '2022-08', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood glucose', 'timeFrame': 'Change of Blood glucose at 1 months', 'description': "Subject's fasting and prandial blood glucose"}, {'measure': 'Inflammation degree', 'timeFrame': 'Change of hs-CRP at 1 Months', 'description': "Subject's high sensitivity C-reactive protein level"}, {'measure': 'insulin resistance', 'timeFrame': 'Change of HOMA IR at 1 Months', 'description': "Subject's HOMA IR"}, {'measure': 'HbA1c', 'timeFrame': 'Change of HbA1C at 1 Months', 'description': "Subject's glycated haemoglobin level"}], 'secondaryOutcomes': [{'measure': 'Body Mass Index', 'timeFrame': 'Change of BMI at 1 Months', 'description': "Subject's height and body weight"}, {'measure': 'Blood Pressure', 'timeFrame': 'Change fof blood prssure at 1 Months', 'description': "Subject's blood pressure"}]}, 'oversightModule': {'oversightHasDmc': True, 'isFdaRegulatedDrug': False, 'isFdaRegulatedDevice': False}, 'conditionsModule': {'keywords': ['curcumin', 'coconut oil', 'diabetes mellitus'], 'conditions': ['Diabetes Mellitus, Type 2', 'Insulin Resistance', 'Inflammation', 'Body Weight']}, 'descriptionModule': {'briefSummary': 'The investigators aim to evaluate the effect of curcumin and virgin coconut oil extract supplementation on people with type 2 DM, including blood glucose, HbA1c levels, inflammation, body weight and insulin resistance evaluation', 'detailedDescription': 'The investigators give Kurcosmart supplementation aside from diabetes standard treatment to evaluate its benefits on people with type 2 DM, considering its effect on controlling fasting and prandial blood glucose, reducing HbA1c level, controlling inflammation degree; and repairing insulin resistance'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'maximumAge': '65 Years', 'minimumAge': '18 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Confirmed Type 2 DM\n* Signing consent form\n\nExclusion Criteria:\n\n* Pregnant or breastfeeding\n* Multiple organ failure\n* History of hypersensitivity reaction to curcumin and virgin coconut oil\n* Cancer, renal insufficiency, hematological disease, acute heart failure, chronic liver disease'}, 'identificationModule': {'nctId': 'NCT05407467', 'briefTitle': 'KurCoSmart Effects on People With Type 2 DM', 'organization': {'class': 'OTHER', 'fullName': 'Universitas Sebelas Maret'}, 'officialTitle': 'KurCoSmart Effects on People With Type 2 DM: a Randomized, Open Trial', 'orgStudyIdInfo': {'id': 'KurCoSmart'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'NO_INTERVENTION', 'label': 'Control Group', 'description': "There is no additional intervention other than subject's standard diabetes treatment"}, {'type': 'EXPERIMENTAL', 'label': 'Interventional Group', 'description': 'This group will received additional supplementation of curcumin and virgin coconut oil aside from their standard treatment', 'interventionNames': ['Dietary Supplement: Curcumin and virgin coconut oil extract (KurCo Smart)']}], 'interventions': [{'name': 'Curcumin and virgin coconut oil extract (KurCo Smart)', 'type': 'DIETARY_SUPPLEMENT', 'description': 'we give 2 tablets of curcumin and virgin coconut oil extract thrice a day for 30 days and evaluate the result', 'armGroupLabels': ['Interventional Group']}]}, 'contactsLocationsModule': {'locations': [{'zip': '57161', 'city': 'Sukoharjo', 'state': 'Central Java', 'country': 'Indonesia', 'contacts': [{'name': 'Desy Puspa Putri, Master', 'role': 'CONTACT', 'email': 'desypuspa@staff.uns.ac.id', 'phone': '+6281283284827'}, {'name': 'Nurhasan Agung Prabowo, Master', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Yulia Sari, Doctor', 'role': 'PRINCIPAL_INVESTIGATOR'}, {'name': 'Desy Puspa Putri, Master', 'role': 'SUB_INVESTIGATOR'}], 'facility': 'UNS Hospital', 'geoPoint': {'lat': -7.73778, 'lon': 110.49861}}], 'centralContacts': [{'name': 'Nurhasan Agung Prabowo, MD', 'role': 'CONTACT', 'email': 'dr.Nurhasan21@staff.uns.ac.id', 'phone': '6282328010430'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO', 'description': 'Individual participant data will be restricted for this study purpose only'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Universitas Sebelas Maret', 'class': 'OTHER'}, 'responsibleParty': {'type': 'PRINCIPAL_INVESTIGATOR', 'investigatorTitle': 'M.D.', 'investigatorFullName': 'Nurhasan Agung Prabowo', 'investigatorAffiliation': 'Universitas Sebelas Maret'}}}}