Ignite Creation Date:
2025-12-25 @ 1:21 AM
Ignite Modification Date:
2025-12-28 @ 1:31 PM
Study NCT ID:
NCT02660593
Status:
UNKNOWN
Last Update Posted:
2016-04-27
First Post:
2016-01-17
Is NOT Gene Therapy:
True
Has Adverse Events:
False
Brief Title:
Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes
Sponsor:
Organization:
Raw JSON
{'hasResults': False, 'derivedSection': {'miscInfoModule': {'versionHolder': '2025-12-24'}, 'conditionBrowseModule': {'meshes': [{'id': 'D003920', 'term': 'Diabetes Mellitus'}, {'id': 'D009043', 'term': 'Motor Activity'}], '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': 'D001519', 'term': 'Behavior'}]}}, 'protocolSection': {'designModule': {'phases': ['NA'], 'studyType': 'INTERVENTIONAL', 'designInfo': {'allocation': 'NA', 'maskingInfo': {'masking': 'NONE'}, 'primaryPurpose': 'TREATMENT', 'interventionModel': 'SINGLE_GROUP'}, 'enrollmentInfo': {'type': 'ESTIMATED', 'count': 20}}, 'statusModule': {'overallStatus': 'UNKNOWN', 'lastKnownStatus': 'RECRUITING', 'startDateStruct': {'date': '2016-03'}, 'expandedAccessInfo': {'hasExpandedAccess': False}, 'statusVerifiedDate': '2016-01', 'completionDateStruct': {'date': '2017-07', 'type': 'ESTIMATED'}, 'lastUpdateSubmitDate': '2016-04-26', 'studyFirstSubmitDate': '2016-01-17', 'studyFirstSubmitQcDate': '2016-01-20', 'lastUpdatePostDateStruct': {'date': '2016-04-27', 'type': 'ESTIMATED'}, 'studyFirstPostDateStruct': {'date': '2016-01-21', 'type': 'ESTIMATED'}, 'primaryCompletionDateStruct': {'date': '2017-03', 'type': 'ESTIMATED'}}, 'outcomesModule': {'primaryOutcomes': [{'measure': 'Blood Sugar level', 'timeFrame': 'From baseline to 30 and 90 days', 'description': 'Fast glucose change between the baseline and end of study'}]}, 'oversightModule': {'oversightHasDmc': False}, 'conditionsModule': {'keywords': ['Diabetes Mellitus', 'Chinese medicine', 'exercise', 'diet'], 'conditions': ['Diabetes Mellitus']}, 'descriptionModule': {'briefSummary': 'MedlinePlus related topics: Blood Sugar\n\nPrimary Outcome Measures:\n\n* Fast glucose and HbA1c change between the baseline and end of study \\[ Time Frame: From baseline to 30 and 100 days\\]\n* \\[ Designated as safety issue: No \\]\n* Successful rate of blood glucose control (the proportion of patients with HbA1c \\<7%) \\[ Time Frame: From baseline to 30 days and 100 days\\] \\[ Designated as safety issue: No \\]\n\nSecondary Outcome Measures:\n\n• To evaluate the change of quality of life in the 1 months by the health questionnaire SF-36 \\[ Time Frame: From baseline to month 1 \\] \\[ Designated as safety issue: No \\]', 'detailedDescription': 'This study is aimed to evaluate the safety and efficacy of Sangrow Decotion, diet and exercise for the treatment of type 2 diabetes. Previous study has shown that this therapeutic regimen is safe and effective.'}, 'eligibilityModule': {'sex': 'ALL', 'stdAges': ['CHILD', 'ADULT', 'OLDER_ADULT'], 'maximumAge': '70 Years', 'minimumAge': '10 Years', 'healthyVolunteers': False, 'eligibilityCriteria': 'Inclusion Criteria:\n\n* Type II diabetes mellitus patients who have received medical treatment for more than 3 months\n* Patients willing to sign written informed consent form\n\nExclusion Criteria:\n\n* Patients unable or unwilling to comply with the requirements of the protocol\n* Females who are pregnant or nursing or females of childbearing potential who are unwilling to maintain contraceptive therapy for the duration of the study\n* Life expectancy \\< 6 months due to concomitant illnesses.'}, 'identificationModule': {'nctId': 'NCT02660593', 'briefTitle': 'Efficacy and Safety ofSanGrow Decoction for Patients With Diabetes', 'organization': {'class': 'OTHER', 'fullName': 'Shidaihuajing Institute for Diabetic Research'}, 'officialTitle': 'SanGrow Decoction in Patients With Diabetes- Single Center, Open, and Non-randomized Study', 'orgStudyIdInfo': {'id': 'SanGrow Decoction for diabetes'}}, 'armsInterventionsModule': {'armGroups': [{'type': 'EXPERIMENTAL', 'label': 'SanGrow', 'description': 'Patients will be given SanGrow Decoction 150 ml per day for 3 months.', 'interventionNames': ['Dietary Supplement: SanGrow Decoction']}], 'interventions': [{'name': 'SanGrow Decoction', 'type': 'DIETARY_SUPPLEMENT', 'description': 'SanGrow Decoction is perpared according to the principle of Chinese medicine to treat thirsty and maransis.', 'armGroupLabels': ['SanGrow']}]}, 'contactsLocationsModule': {'locations': [{'zip': '100001', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chi Shizhan, Master', 'role': 'CONTACT'}], 'facility': 'Jiuhua Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}, {'zip': '100001', 'city': 'Beijing', 'state': 'Beijing Municipality', 'status': 'RECRUITING', 'country': 'China', 'contacts': [{'name': 'Chi Shizhan, Master', 'role': 'CONTACT'}], 'facility': 'Xuanwu Hospital', 'geoPoint': {'lat': 39.9075, 'lon': 116.39723}}], 'centralContacts': [{'name': 'Shizhan Chi, PhD', 'role': 'CONTACT', 'email': 'chishizhan@lawyee.net', 'phone': '86-10-53109996', 'phoneExt': '8088'}], 'overallOfficials': [{'name': 'Shizhan CHi, PhD', 'role': 'STUDY_CHAIR', 'affiliation': 'Shidaihuajing Institute'}]}, 'ipdSharingStatementModule': {'ipdSharing': 'NO'}, 'sponsorCollaboratorsModule': {'leadSponsor': {'name': 'Shidaihuajing Institute for Diabetic Research', 'class': 'OTHER'}, 'responsibleParty': {'type': 'SPONSOR'}}}}