Ignite Creation Date:
2025-12-25 @ 1:20 AM
Ignite Modification Date:
2026-01-01 @ 6:42 PM
Study NCT ID:
NCT02435693
Status:
COMPLETED
Last Update Posted:
2015-11-04
First Post:
2015-02-07
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Pharmaceutical Care Program for Type 2 Diabetes Mellitus
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003924', 'term': 'Diabetes Mellitus, Type 2'}], 'ancestors': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D044882', 'term': 'Glucose Metabolism Disorders'}, {'id': 'D008659', 'term': 'Metabolic Diseases'}, {'id': 'D009750', 'term': 'Nutritional and Metabolic Diseases'}, {'id': 'D004700', 'term': 'Endocrine System Diseases'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'RANDOMIZED', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'SUPPORTIVE_CARE', 'interventionModel': 'PARALLEL'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 600}}, 'statusModule': {'overallStatus': 'COMPLETED', 'startDateStruct': {'date': '2012-07'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2015-11', 'completionDateStruct': {'date': '2015-11', 'type': 'ACTUAL'}, 'lastUpdateSubmitDate': '2015-11-03', 'studyFirstSubmitDate': '2015-02-07', 'studyFirstSubmitQcDate': '2015-05-05', 'lastUpdatePostDateStruct': {'date': '2015-11-04', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2015-05-06', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2015-06', 'type': 'ACTUAL'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded: Fasting blood glucose measurements recorded (mg/dl).Postprandial bloodglucoseRecorded', 'timeFrame': '24 weeks', 'description': 'Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded Fasting blood glucose measurements recorded (mg/dl).Postprandial blood glucose Recorded fasting blood glucose'}], 'secondaryOutcomes': [{'measure': 'Quality of Life score', 'timeFrame': '24 weeks', 'description': 'Quality of Life score'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['pharmaceutical care'], 'conditions': ['DIABETES MELLITUS, TYPE 2']}, 'descriptionModule': {'briefSummary': "Evaluation of Pharmaceutical Care Program for Type 2 diabetes mellitus in Dhule\n\nObjectives:-\n\n1. To evaluate Pharmaceutical care program in Type2 diabetics.\n2. To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.\n3. To study the prevalence of Type2 diabetics cases in Dhule.\n4. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.\n5. To evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.\n6. To study the impacts of Pharmaceutical care program on glycemic control in patients with Type-2 Diabetes Mellitus.\n7. To study the Drug utilization pattern in Type-2 Diabetes Mellitus in civil hospital Dhule.\n8. To compare the efficiency of Pharmaceutical care program and drug in patients with Type-2 Diabetes Mellitus.\n9. To study the Pharmaco-economic evaluation in Type-2 Diabetes Mellitus patient's.\n10. To increase the patient compliance and positive attitude of patients towards the diabetes disease by counseling.", 'detailedDescription': 'To evaluate the impacts of Pharmaceutical care on quality of life (QOL) in patient with Type-2 Diabetes Mellitus.\n\nTo study the prevalence of Type2 diabetics cases in Dhule. To study the Assessment of different type of adverse drug reactions (ADRs). In Type2 diabetics.\n\nTo evaluate the Drug Drug intereaction in Type-2 Diabetes Mellitus.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['ADULT', 'OLDER_ADULT'], 'minimumAge': '35 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:Inclusion Criteria:\n\n* Patients with type 2 diabetes mellitus of either\n* Patients with HbA1c more than 7% and\n* Patients with blood sugar level more than 140 mg / dl\n\nExclusion Criteria:\n\n* Patient with end stage kidney disease.\n* Patient with heart failure.\n* Patient with chronic Diabetes problem and orthopedic problem'}, 'identificationModule': {'nctId': 'NCT02435693', 'acronym': 'pcp', 'briefTitle': 'Pharmaceutical Care Program for Type 2 Diabetes Mellitus', 'organization': {'class': 'OTHER', 'fullName': 'R. C. Patel Institute of Pharmaceutical Education & Research'}, 'officialTitle': 'Evaluation of Pharmaceutical Care Program for Type 2 Diabetes Mellitus in Dhule', 'orgStudyIdInfo': {'id': 'pc'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'PHARMACEUTICAL CARE programe', 'description': 'The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.', 'interventionNames': ['Other: PHARMACEUTICAL CARE programe']}, {'type': 'OTHER', 'label': 'control', 'description': 'without pharmaceutical care programe (control)', 'interventionNames': ['Other: Without PHARMACEUTICAL CARE programe']}], 'interventions': [{'name': 'PHARMACEUTICAL CARE programe', 'type': 'OTHER', 'description': 'The pharmaceutical care program was characterized by face to face monthly visits to collect information, register information, prepare plan of care for every health problem; identification of drug therapy problems, communication to prescribers the drug therapy problems identified and education of participants to resolve the drug therapy problems.', 'armGroupLabels': ['PHARMACEUTICAL CARE programe']}, {'name': 'Without PHARMACEUTICAL CARE programe', 'type': 'OTHER', 'armGroupLabels': ['control']}]}, 'contactsLocationsModule': {'locations': [{'zip': '424001', 'city': 'Dhule', 'state': 'Maharashtra', 'country': 'India', 'facility': 'Tabrej Aj Mujawar', 'geoPoint': {'lat': 20.9013, 'lon': 74.77737}}], 'overallOfficials': [{'name': 'tabrej aj mujawar, mpharm', 'role': 'PRINCIPAL_INVESTIGATOR', 'affiliation': 'muhs'}]}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'TABREJ MUJAWAR', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR_INVESTIGATOR', 'investigatorTitle': 'tabrej mujawar mpharm Study principal investigator', 'investigatorFullName': 'TABREJ MUJAWAR', 'investigatorAffiliation': 'R. C. Patel Institute of Pharmaceutical Education & Research'}}}}