[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100629468":3},{"organization":4,"armGroups":7,"interventions":20,"overallOfficials":32,"centralContacts":37,"locations":42,"responsibleParty":58,"collaborators":61,"id":65,"slug":66,"hasResults":67,"nctId":68,"briefTitle":69,"officialTitle":70,"acronym":31,"eligibilityCriteria":71,"healthyVolunteers":67,"sex":72,"minAge":73,"maxAge":74,"enrollmentInfo":75,"targetDuration":31,"studyType":78,"phases":79,"briefSummary":82,"conditions":83,"keywords":88,"overallStatus":101,"whyStopped":31,"lastUpdateSubmitDate":102,"lastUpdatePostDateStruct":103,"startDateStruct":106,"completionDateStruct":108,"leadSponsor":110,"locationsCount":111},{"fullName":5,"class":6},"Universitas Sebelas Maret","OTHER",[8,15],{"label":9,"type":10,"description":11,"interventionNames":12},"Experimental: DLBS1033 + Standard Therapy","EXPERIMENTAL","Participants receive oral DLBS1033 as adjuvant therapy in addition to standard therapy for diabetic polyneuropathy.\n\nIntervention Drug: DLBS1033 Dose: 980 mg orally, three times daily Duration: 28 days Description: DLBS1033 contains lumbrokinase (Lumbricus low-molecular-weight proteins) with anti-inflammatory, fibrinolytic, and neuroregenerative activity.\n\nOther Components: Standard therapy for diabetic polyneuropathy (per treating physician).",[13,14],"Drug: DLBS1033","Drug: Placebo Comparator: Placebo + Standard Therapy",{"label":16,"type":17,"description":18,"interventionNames":19},"Placebo Comparator: Placebo + Standard Therapy","PLACEBO_COMPARATOR","Participants receive placebo capsules identical in appearance to DLBS1033, in addition to standard therapy.\n\nIntervention Drug: Placebo Dose: Matching placebo, orally, three times daily Duration: 28 days Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).",[13,14],[21,28],{"type":22,"name":23,"description":24,"armGroupLabels":25,"otherNames":26},"DRUG","DLBS1033","Intervention Drug: DLBS1033 Dose: 980 mg orally, three times daily Duration: 28 days\n\nDescription: DLBS1033 contains lumbrokinase (Lumbricus low-molecular-weight proteins) with anti-inflammatory, fibrinolytic, and neuroregenerative activity.\n\nOther Components: Standard therapy for diabetic polyneuropathy (per treating physician).",[9,16],[27],"lumbrokinase",{"type":22,"name":16,"description":29,"armGroupLabels":30,"otherNames":31},"Participants receive placebo capsules identical in appearance to DLBS1033, in addition to standard therapy.\n\nIntervention Drug: Placebo Dose: Matching placebo, orally, three times daily Duration: 28 days\n\nOther Components: Standard therapy for diabetic polyneuropathy (per treating physician).",[9,16],null,[33],{"name":34,"affiliation":35,"role":36},"Krisandi Hartanto, MD","Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret","PRINCIPAL_INVESTIGATOR",[38],{"name":34,"role":39,"phone":40,"phoneExt":31,"email":41},"CONTACT","+6281256081415","krisandyhartanto@yahoo.com",[43],{"facility":44,"status":31,"city":45,"state":46,"zip":47,"country":48,"countryCode":49,"cosmosGeoPoint":50,"geoPoint":55,"contacts":56},"Dr. Moewardi Regional General Hospital","Surakarta","Central Java","57143","Indonesia","ID",{"type":51,"coordinates":52},"Point",[53,54],110.83167,-7.55611,{"lat":54,"lon":53},[57],{"name":34,"role":39,"phone":40,"phoneExt":31,"email":41},{"type":36,"investigatorFullName":59,"investigatorTitle":60,"investigatorAffiliation":5,"oldNameTitle":31,"oldOrganization":31},"Krisandi Hartanto","MD",[62],{"name":63,"class":64},"Dexa Medica Group","INDUSTRY","100629468","phase-2-the-effect-of-oral-dlbs1033-in-patients-with-diabetic-polyneuropathy-100629468",false,"NCT07475065","The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy","The Effect of Oral DLBS1033 as Adjuvant Therapy on Inflammatory Biomarkers, Neuroregeneration Biomarkers, and Disease Severity in Patients With Diabetic Polyneuropathy: A Randomized Controlled Trial (An Evaluation of Changes in TCNS, TNF-α, NGF, and Sensory Nerve Conduction Study of the Sural Nerve)","Inclusion Criteria:\n\n* Adults aged 40-60 years diagnosed with diabetic polyneuropathy by a neurologist or neurology resident.\n* Patients with HbA1c levels between 7-10% within the past 30 days.\n* Willing to participate and able to sign the informed consent form.\n\nExclusion Criteria:\n\n* Pregnant, breastfeeding, or planning pregnancy.\n* History of other neurological diseases such as stroke, myelopathy, alcoholic neuropathy, or compressive radiculopathy.\n* Significant renal impairment (creatinine \\> 1.5× upper limit of normal), hepatic impairment (SGOT or SGPT \\> 3× upper limit of normal), or severe cardiac disease (NYHA class III-IV heart failure).\n* History of alcohol consumption for ≥ 5 consecutive years.\n* Heavy smoker (Brinkman Index \\> 600).\n* Known allergy or intolerance to DLBS1033.\n* Autoimmune disease, malignancy, or acute and\u002For chronic inflammatory conditions other than diabetic polyneuropathy.\n* Participation in another interventional pharmacological clinical study within 30 days prior to screening.\n* Currently taking anti-inflammatory and\u002For antioxidant medications.","ALL","40 Years","60 Years",{"count":76,"type":77},34,"ESTIMATED","INTERVENTIONAL",[80,81],"PHASE2","PHASE3","This study aims to evaluate whether oral DLBS1033 can improve clinical symptoms and biological markers of nerve damage in adults with diabetic polyneuropathy. The trial enrolls patients with type 2 diabetes who show clinical signs of peripheral nerve injury.\n\nParticipants will receive either DLBS1033 as adjuvant therapy or standard therapy alone for 28 days. The study will compare changes in neuropathy severity (Toronto Clinical Neuropathy Score), inflammatory biomarkers (TNF-α), neuroregeneration biomarkers (Nerve Growth Factor), and sensory nerve conduction parameters of the sural nerve between the two groups. Blood tests, clinical assessments, and nerve conduction studies will be performed at baseline and follow-up visits. Participants will also report any symptoms or adverse events throughout the study.",[84,85,86,87],"Diabetic Polyneuropathy","Peripheral Nervous System Diseases","Peripheral Neuropathy","Diabetes Mellitus",[23,27,89,90,91,92,93,94,95,96,97,98,99,100],"diabetic polyneuropathy","peripheral neuropathy","Toronto Clinical Neuropathy Score","TNF-α","TNF-alpha","Nerve Growth Factor","sural nerve","nerve conduction study","NCS","EMG","ENMG","Electromyography","NOT_YET_RECRUITING","2026-03-13",{"date":104,"type":105},"2026-03-16","ACTUAL",{"date":107,"type":77},"2026-03-01",{"date":109,"type":77},"2026-06-30",{"name":5,"class":6},1]