Nctid:
NCT06224803
Payload:
{"hasResults"=>false, "derivedSection"=>{"miscInfoModule"=>{"versionHolder"=>"2024-12-20"}, "conditionBrowseModule"=>{"meshes"=>[{"id"=>"D003920", "term"=>"Diabetes Mellitus"}, {"id"=>"D003924", "term"=>"Diabetes Mellitus, Type 2"}], "ancestors"=>[{"id"=>"D044882", "term"=>"Glucose Metabolism Disorders"}, {"id"=>"D008659", "term"=>"Metabolic Diseases"}, {"id"=>"D004700", "term"=>"Endocrine System Diseases"}], "browseLeaves"=>[{"id"=>"M7115", "name"=>"Diabetes Mellitus", "asFound"=>"Diabetes", "relevance"=>"HIGH"}, {"id"=>"M7119", "name"=>"Diabetes Mellitus, Type 2", "asFound"=>"Type II Diabetes", "relevance"=>"HIGH"}, {"id"=>"M11639", "name"=>"Metabolic Diseases", "relevance"=>"LOW"}, {"id"=>"M25403", "name"=>"Glucose Metabolism Disorders", "relevance"=>"LOW"}, {"id"=>"M7862", "name"=>"Endocrine System Diseases", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Nutritional and Metabolic Diseases", "abbrev"=>"BC18"}, {"name"=>"Gland and Hormone Related Diseases", "abbrev"=>"BC19"}, {"name"=>"All Conditions", "abbrev"=>"All"}]}, "interventionBrowseModule"=>{"browseLeaves"=>[{"id"=>"M4513", "name"=>"Ascorbic Acid", "relevance"=>"LOW"}, {"id"=>"T312", "name"=>"Tea", "relevance"=>"LOW"}, {"id"=>"T294", "name"=>"Soy Bean", "relevance"=>"LOW"}, {"id"=>"T477", "name"=>"Vitamin C", "relevance"=>"LOW"}, {"id"=>"T437", "name"=>"Ascorbic Acid", "relevance"=>"LOW"}, {"id"=>"T173", "name"=>"Grape", "relevance"=>"LOW"}, {"id"=>"T98", "name"=>"Celeriac", "relevance"=>"LOW"}, {"id"=>"T69", "name"=>"Bitter Melon", "relevance"=>"LOW"}, {"id"=>"T368", "name"=>"Brewer's Yeast", "relevance"=>"LOW"}], "browseBranches"=>[{"name"=>"Micronutrients", "abbrev"=>"Micro"}, {"name"=>"All Drugs and Chemicals", "abbrev"=>"All"}, {"name"=>"Herbal and Botanical", "abbrev"=>"HB"}, {"name"=>"Vitamins", "abbrev"=>"Vi"}, {"name"=>"Other Dietary Supplements", "abbrev"=>"Ot"}]}}, "protocolSection"=>{"designModule"=>{"phases"=>["NA"], "studyType"=>"INTERVENTIONAL", "designInfo"=>{"allocation"=>"RANDOMIZED", "maskingInfo"=>{"masking"=>"TRIPLE", "whoMasked"=>["PARTICIPANT", "CARE_PROVIDER", "INVESTIGATOR"]}, "primaryPurpose"=>"OTHER", "interventionModel"=>"PARALLEL"}, "enrollmentInfo"=>{"type"=>"ACTUAL", "count"=>56}}, "statusModule"=>{"overallStatus"=>"COMPLETED", "startDateStruct"=>{"date"=>"2020-08-26", "type"=>"ACTUAL"}, "expandedAccessInfo"=>{"hasExpandedAccess"=>false}, "statusVerifiedDate"=>"2024-01", "completionDateStruct"=>{"date"=>"2022-01-18", "type"=>"ACTUAL"}, "lastUpdateSubmitDate"=>"2024-01-17", "studyFirstSubmitDate"=>"2024-01-08", "studyFirstSubmitQcDate"=>"2024-01-17", "lastUpdatePostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "studyFirstPostDateStruct"=>{"date"=>"2024-01-25", "type"=>"ACTUAL"}, "primaryCompletionDateStruct"=>{"date"=>"2021-07-21", "type"=>"ACTUAL"}}, "outcomesModule"=>{"primaryOutcomes"=>[{"measure"=>"Concentration of HbA1c", "timeFrame"=>"per 30 days for 7 months", "description"=>"Concentration of HbA1c is assessed every 30 day for 7 months"}], "secondaryOutcomes"=>[{"measure"=>"Concentration of Blood Sugar", "timeFrame"=>"everyday for 7 months", "description"=>"AC \\& PC blood sugar is measured and recorded by the subjects everyday for 7 months"}]}, "oversightModule"=>{"oversightHasDmc"=>false, "isFdaRegulatedDrug"=>false, "isFdaRegulatedDevice"=>false}, "conditionsModule"=>{"conditions"=>["Type II Diabetes"]}, "descriptionModule"=>{"briefSummary"=>"At present, diabetic patients mainly use drugs to control blood sugar. However, drugs have side effects and the control effect varies among individuals. Even if diabetic patients can control their blood sugar well, long-term medication will still cause a series of complications, including retinopathy, nephropathy, diabetic foot, heart disease, etc. Vascular disease issues, etc.\n\nThis study will focus on the changes in HbA1c and blood sugar in patients with confirmed diabetes after taking \"Dibifree®\" food supplement."}, "eligibilityModule"=>{"sex"=>"ALL", "stdAges"=>["ADULT", "OLDER_ADULT"], "minimumAge"=>"20 years", "healthyVolunteers"=>false, "eligibilityCriteria"=>"Inclusion Criteria:\n\n1. Age: 20 years old (inclusive) or above, gender is not restricted\n2. Diagnosed with type 2 diabetes\n3. HbA1c \\> 6.5%\n4. Coagulation function and platelets are normal\n5. Participants voluntarily join this treatment course and sign the informed consent form\n6. Not taking other supplements containing blood sugar regulating properties for at least one month\n\nExclusion Criteria:\n\n1. Women who are pregnant, lactating or planning to have children\n2. Have factors that significantly affect the absorption of oral drugs, such as inability to swallow, chronic diarrhea, intestinal obstruction, etc.\n3. Uncontrolled hypertension (\\>180/110 mmHG)\n4. People suffering from stroke, elderly dementia, Alzheimer's disease and other brain diseases\n5. During this study, the subject used other drugs or treatments that may interfere with this study in addition to blood sugar control medications.\n6. GOT\\>4 times normal value; GPT\\>4 times normal value\n7. Creatinine\\>4 times the highest normal value\n8. Those who are determined by the project administrator to be unfit to participate in this clinical study"}, "identificationModule"=>{"nctId"=>"NCT06224803", "briefTitle"=>"Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes", "organization"=>{"class"=>"INDUSTRY", "fullName"=>"Global Preventive Medicine Biotech Co., Ltd."}, "officialTitle"=>"Evaluation of Effects of Dibifree® on Regulation of Blood Sugar and HbA1c in Patients With Type II Diabetes", "orgStudyIdInfo"=>{"id"=>"DF202006001"}}, "armsInterventionsModule"=>{"armGroups"=>[{"type"=>"EXPERIMENTAL", "label"=>"Dibifree", "description"=>"Take Dibifree 3 times a day, 10 capsules each time, 5 to 10 minutes before meals", "interventionNames"=>["Dietary Supplement: Compound plant extracts"]}, {"type"=>"PLACEBO_COMPARATOR", "label"=>"Control", "description"=>"Take Placebo 3 times a day, 10 capsules each time, 5 to 10 minutes before meals", "interventionNames"=>["Dietary Supplement: Indigestible dextrin"]}], "interventions"=>[{"name"=>"Compound plant extracts", "type"=>"DIETARY_SUPPLEMENT", "otherNames"=>["Dibifree"], "description"=>"Total supplement including bitter melon (Momordica charantia) fruit extract, celery (Apium graveolens) seed extract, baker's yeast (Saccharomyces cerevisiae) cell wall extract, acerola (Malpighia emarginata) fruit extract, grape (Vitis vinifera) seed extract, green tea leaf extract, and hydrolyzed soy protein powder.", "armGroupLabels"=>["Dibifree"]}, {"name"=>"Indigestible dextrin", "type"=>"DIETARY_SUPPLEMENT", "otherNames"=>["Control"], "description"=>"Indigestible dextrin as placebo intervention", "armGroupLabels"=>["Control"]}]}, "contactsLocationsModule"=>{"locations"=>[{"zip"=>"221416", "city"=>"New Taipei", "country"=>"Taiwan", "facility"=>"Global Preventive Medicine Biotech Co., Ltd.", "geoPoint"=>{"lat"=>25.01111, "lon"=>121.44583}}]}, "ipdSharingStatementModule"=>{"ipdSharing"=>"NO"}, "sponsorCollaboratorsModule"=>{"leadSponsor"=>{"name"=>"Global Preventive Medicine Biotech Co., Ltd.", "class"=>"INDUSTRY"}, "responsibleParty"=>{"type"=>"SPONSOR"}}}}
