[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100585529":3},{"organization":4,"outcomesModule":7,"designInfo":17,"detailedDescription":29,"studyPopulation":16,"armGroups":30,"interventions":43,"overallOfficials":53,"centralContacts":57,"locations":66,"responsibleParty":83,"collaborators":16,"id":86,"slug":16,"hasResults":87,"nctId":88,"briefTitle":89,"officialTitle":90,"acronym":16,"eligibilityCriteria":91,"healthyVolunteers":87,"sex":92,"minAge":93,"maxAge":94,"enrollmentInfo":95,"targetDuration":16,"studyType":98,"phases":99,"briefSummary":101,"conditions":102,"keywords":104,"overallStatus":69,"whyStopped":16,"lastUpdateSubmitDate":106,"lastUpdatePostDateStruct":107,"startDateStruct":110,"completionDateStruct":112,"leadSponsor":114,"locationsCount":115},{"fullName":5,"class":6},"Indonesia University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":16,"otherOutcomes":16},[9,13],{"measure":10,"description":11,"timeFrame":12},"Low Density Lipoprotein","LDL level will be measured twice, before and after intervention","8 weeks",{"measure":14,"description":15,"timeFrame":12},"High Density Lipoprotein","HDL will be measured twice, before and after intervention",null,{"allocation":18,"interventionModel":19,"interventionModelDescription":20,"primaryPurpose":21,"observationalModel":16,"timePerspective":16,"maskingInfo":22},"RANDOMIZED","PARALLEL","The participants will be randomly allocated into two groups that will recieve either propolis or plasebo. The study model is double-blinded trial.\n\nThe participants are patients undergoing treatment for type 2 diabetes in multiple sub-dictrict health centre in Central Jakarta and will be screened based on inclusion and exclusion criteria.","PREVENTION",{"masking":23,"maskingDescription":16,"whoMasked":24},"QUADRUPLE",[25,26,27,28],"PARTICIPANT","CARE_PROVIDER","INVESTIGATOR","OUTCOMES_ASSESSOR","Subject allocation into groups will be made by third party to ensure masking\u002F blinding protocol.\n\nData that will be taken from participants :\n\n* Private information\n* Medication history (for type 2 Diabetes Mellitus)\n* Food intake (calories, fats, carbohydrate, protein, and flavonoid intake)\n* Physical activity status",[31,37],{"label":32,"type":33,"description":34,"interventionNames":35},"Intervention group","EXPERIMENTAL","This group will receive the intervention, which in this study is propolis with dose given 1 drop\u002Fkg\u002Ftime given, 2 times daily, for 8 weeks (2 months)",[36],"Drug: Propolis drops",{"label":38,"type":39,"description":40,"interventionNames":41},"Control group","PLACEBO_COMPARATOR","This group will receive placebo (a look-alike substance that contains no drug) with dose given 1 drop\u002Fkg\u002Ftime given, 2 times daily, for 8 weeks (2 months)",[42],"Other: Placebo",[44,49],{"type":45,"name":46,"description":47,"armGroupLabels":48,"otherNames":16},"DRUG","Propolis drops","The intervention given is propolis drops that are approved by Indonesian Food and Drug Authority",[32],{"type":6,"name":50,"description":51,"armGroupLabels":52,"otherNames":16},"Placebo","The given placebo are look-alike substance with no effect",[38],[54],{"name":55,"affiliation":5,"role":56},"Dwirini R Gunarti, Biomed Science","PRINCIPAL_INVESTIGATOR",[58,62],{"name":55,"role":59,"phone":60,"phoneExt":16,"email":61},"CONTACT","+62 8118382301","rinairet@gmail.com",{"name":63,"role":59,"phone":64,"phoneExt":16,"email":65},"Wiryani Sentosa, MD","+62 81210977847","wiryani@ymail.com",[67],{"facility":68,"status":69,"city":70,"state":16,"zip":71,"country":72,"countryCode":73,"cosmosGeoPoint":74,"geoPoint":79,"contacts":80},"University of Indonesia Faculty of Biomedical Science","RECRUITING","Jakarta","10430","Indonesia","ID",{"type":75,"coordinates":76},"Point",[77,78],106.84513,-6.21462,{"lat":78,"lon":77},[81],{"name":82,"role":59,"phone":60,"phoneExt":16,"email":61},"Dwirini R Gunarti",{"type":56,"investigatorFullName":84,"investigatorTitle":85,"investigatorAffiliation":5,"oldNameTitle":16,"oldOrganization":16},"Dr. drg. Dwirini Retno Gunarti, M.S.","Associate Professor","100585529",false,"NCT06903546","The Effect of Propolis Administration on Cholesterol Level in Diabetic Type 2 Patients","The Effect of Propolis Administration on Low Density Lipoprotein and High Density Lipoprotein in Diabetic Type 2 Patients in Central Jakarta","Inclusion Criteria:\n\n* Controlled Diabetes Mellitus type 2 with HbA1c \\\u003C7.5%\n* BMI 23-35 kg\u002Fm2\n* On anti-cholesterol therapy\n\nExclusion Criteria:\n\n* Using injection therapy (insulin or GLP-1 RA)\n* History of bees product allergy\n* Active smoker\n* Consuming alcohol\n* Altered liver (ALT\\>35 IU\u002FL) and kidney (eGFR\\\u003C90 mL\u002Fmin) function\n* Pregnant and breastfeeding women\n* History of cardiovascular disease (heart attack, stroke)","ALL","35 Years","59 Years",{"count":96,"type":97},64,"ESTIMATED","INTERVENTIONAL",[100],"PHASE4","The goal of this clinical trial is to learn if propolis administration works to change the level of Low Density Lipoprotein (LDL) and High Density Lipoprotein cholesterol (HDL) in diabetic type 2 patients.\n\nThe main questions it aims to answer are:\n\n\\- Is giving 1 drops\u002F 10kg\u002F times, twice daily for 8 weeks will change the level of LDL and HDL level in diabetic type 2 patients compared to placebo? Researchers will compare propolis to a placebo (a look-alike substance that contains no drug) to see if propolis works to change LDL and HDL cholesterol level.\n\nParticipants will:\n\n* Take propolis or a placebo, 2 times daily with given dose (1 drops\u002F10 kg\u002Ftimes) every day for 2 months\n* Visit the sub-district health centre once every 2 weeks for checkups\n* Get their blood checked before and after intervention",[103],"Diabetes Mellitus Type 2",[105,103,10,14],"Propolis","2025-03-29",{"date":108,"type":109},"2025-04-03","ACTUAL",{"date":111,"type":109},"2025-03-18",{"date":113,"type":97},"2025-07-31",{"name":5,"class":6},1]