[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100646911":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":34,"centralContacts":39,"locations":45,"responsibleParty":62,"collaborators":43,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":43,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":43,"enrollmentInfo":74,"targetDuration":43,"studyType":77,"phases":78,"briefSummary":80,"conditions":81,"keywords":83,"overallStatus":91,"whyStopped":43,"lastUpdateSubmitDate":92,"lastUpdatePostDateStruct":93,"startDateStruct":96,"completionDateStruct":98,"leadSponsor":100,"locationsCount":101},{"fullName":5,"class":6},"RS H Adam Malik","OTHER",[8,14],{"label":9,"type":10,"description":11,"interventionNames":12},"DLBS1033 Plus Standard Therapy","EXPERIMENTAL","Participants in this arm will receive DLBS1033 as adjunctive therapy in addition to standard therapy for diabetic neuropathy for 12 weeks.",[13],"Dietary Supplement: DLBS1033",{"label":15,"type":16,"description":17,"interventionNames":18},"Placebo Plus Standard Therapy","PLACEBO_COMPARATOR","Participants in this arm will receive placebo in addition to standard therapy for diabetic neuropathy for 12 weeks.",[19],"Dietary Supplement: Placebo",[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DIETARY_SUPPLEMENT","DLBS1033","DLBS1033 is a standardized bioactive extract derived from Lumbricus rubellus. Participants assigned to the intervention arm will receive DLBS1033 1 capsule orally three times daily for 12 weeks, in addition to standard therapy for diabetic neuropathy.",[9],[27],"Lumbricus rubellus Extract",{"type":22,"name":29,"description":30,"armGroupLabels":31,"otherNames":32},"Placebo","Participants assigned to the control arm will receive a matching placebo capsule orally three times daily for 12 weeks, in addition to standard therapy for diabetic neuropathy.",[15],[33],"Placebo capsule",[35],{"name":36,"affiliation":37,"role":38},"Putri Gily De La Glory Ginting, Medical Doctor","Department of Neurology, RS H Adam Malik","PRINCIPAL_INVESTIGATOR",[40],{"name":36,"role":41,"phone":42,"phoneExt":43,"email":44},"CONTACT","+6282276141617",null,"putriginting99@gmail.com",[46],{"facility":5,"status":43,"city":47,"state":48,"zip":49,"country":50,"countryCode":51,"cosmosGeoPoint":52,"geoPoint":57,"contacts":58},"Medan","North Sumatera","20136","Indonesia","ID",{"type":53,"coordinates":54},"Point",[55,56],98.66667,3.58333,{"lat":56,"lon":55},[59,61],{"name":60,"role":41,"phone":42,"phoneExt":43,"email":44},"Putri Gily De La Glory Ginting, MD",{"name":36,"role":38,"phone":43,"phoneExt":43,"email":43},{"type":38,"investigatorFullName":63,"investigatorTitle":64,"investigatorAffiliation":5,"oldNameTitle":43,"oldOrganization":43},"Putri Gily De La Glory Ginting","Resident, Department of Neurology","100646911","dlbs1033-as-adjunctive-therapy-for-patients-with-diabetic-neuropathy-100646911",false,"NCT07683598","DLBS1033 as Adjunctive Therapy for Patients With Diabetic Neuropathy","Effect of DLBS1033 as Adjunctive Therapy on Changes in Nerve Conduction Study Parameters, Toronto Clinical Neuropathy Score, Interleukin-8, Galectin-3, and Quality of Life in Patients With Diabetic Neuropathy","Inclusion Criteria:\n\n* Patients diagnosed with diabetic neuropathy based on symptoms and clinical signs of peripheral neuropathy and a Toronto Clinical Neuropathy Score (TCNS) of 6 or higher, representing mild to severe neuropathy.\n* Age 18 years or older.\n* Willing to participate in the study and sign the informed consent form.\n* Able to complete the study procedures and complete the Short Form-36 quality of life questionnaire independently or with assistance from the investigator if needed.\n\nExclusion Criteria:\n\n* Participants with other conditions that may cause non-diabetic peripheral neuropathy, including history of chemotherapy, use of anti-tuberculosis drugs such as isoniazid, heavy alcohol consumption, chronic kidney disease, liver cirrhosis, vitamin B12 deficiency, hypothyroidism, HIV\u002FAIDS, hereditary neuropathy, or neuromuscular disease affecting the peripheral nerves.\n* Participants with acute infection or active inflammatory conditions that may affect interleukin-8 and Galectin-3 levels at the time of sample collection before or after intervention, such as acute infection with fever, infection with systemic manifestations, active malignancy, or active inflammatory autoimmune disease.\n* Allergy or history of hypersensitivity to the active ingredient of DLBS1033.\n* Currently receiving another experimental therapy or participating in another clinical study.\n* Pregnant or breastfeeding women.","ALL","18 Years",{"count":75,"type":76},80,"ESTIMATED","INTERVENTIONAL",[79],"NA","This study will evaluate the effect of DLBS1033 as adjunctive therapy in patients with diabetic neuropathy. Diabetic neuropathy is a common complication of diabetes that can cause numbness, tingling, pain, impaired nerve function, and reduced quality of life.\n\nParticipants with diabetic neuropathy will be randomly assigned to receive either DLBS1033 plus standard therapy or placebo plus standard therapy. The study will assess changes in nerve conduction study parameters, Toronto Clinical Neuropathy Score, interleukin-8, Galectin-3, and quality of life. The purpose of this study is to determine whether DLBS1033 may provide additional benefit as an adjunctive therapy for diabetic neuropathy.",[82],"Diabetic Neuropathy",[23,84,85,86,87,88,89,90],"Lumbricus rubellus","Nerve Conduction Study","Toronto Clinical Neuropathy Score","Interleukin-8","Galectin-3","Quality of Life","SF-36","NOT_YET_RECRUITING","2026-06-27",{"date":94,"type":95},"2026-07-06","ACTUAL",{"date":97,"type":76},"2026-08-01",{"date":99,"type":76},"2027-03-01",{"name":5,"class":6},1]