[{"data":1,"prerenderedAt":-1},["ShallowReactive",2],{"health-study-detail:100653258":3},{"organization":4,"outcomesModule":7,"designInfo":36,"detailedDescription":45,"studyPopulation":35,"armGroups":46,"interventions":59,"overallOfficials":35,"centralContacts":69,"locations":75,"responsibleParty":90,"collaborators":35,"id":94,"slug":95,"hasResults":96,"nctId":97,"briefTitle":98,"officialTitle":99,"acronym":35,"eligibilityCriteria":100,"healthyVolunteers":96,"sex":101,"minAge":102,"maxAge":35,"enrollmentInfo":103,"targetDuration":35,"studyType":106,"phases":107,"briefSummary":109,"conditions":110,"keywords":35,"overallStatus":112,"whyStopped":35,"lastUpdateSubmitDate":113,"lastUpdatePostDateStruct":114,"startDateStruct":117,"completionDateStruct":118,"leadSponsor":120,"locationsCount":121},{"fullName":5,"class":6},"Bangladesh Medical University","OTHER",{"primaryOutcomes":8,"secondaryOutcomes":13,"otherOutcomes":35},[9],{"measure":10,"description":11,"timeFrame":12},"Change in pain intensity measured by Numerical Rating Scale (NRS)","Change in pain intensity from baseline to Week 9, measured using the Numerical Rating Scale (NRS), where 0 indicates no pain and 10 indicates the worst possible pain.","From baseline to Week 9",[14,18,22,25,29,32],{"measure":15,"description":16,"timeFrame":17},"Change in pain intensity measured by NRS","Change in pain intensity from baseline to Week 5, measured using the NRS.","From baseline to Week 5",{"measure":19,"description":20,"timeFrame":21},"Patient Global Impression of Change (PGIC)","Patient-reported global assessment of improvement in painful diabetic peripheral neuropathy following treatment.","Week 5 and Week 9",{"measure":23,"description":24,"timeFrame":21},"Proportion of participants achieving ≥30% reduction in NRS","Proportion of participants achieving at least a 30% reduction in pain intensity from baseline, as measured by the NRS.",{"measure":26,"description":27,"timeFrame":28},"Pattern and frequency of adverse effects","Type, frequency and severity of adverse events occurring during the study period.","Baseline to Week 9",{"measure":30,"description":31,"timeFrame":28},"Treatment tolerability","Assessment of treatment tolerability based on reported adverse effects and treatment discontinuation.",{"measure":33,"description":34,"timeFrame":28},"Treatment compliance","Proportion of prescribed study medication doses taken during the study period.",null,{"allocation":37,"interventionModel":38,"interventionModelDescription":39,"primaryPurpose":40,"observationalModel":35,"timePerspective":35,"maskingInfo":41},"RANDOMIZED","PARALLEL","Participants will be randomly assigned in a 1:1 ratio to one of two parallel treatment groups. Group A will receive duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily, while Group B will receive duloxetine 60 mg once daily. Both groups will receive duloxetine 30 mg once daily during Week 1; from Week 2 onward, Group A will continue duloxetine 30 mg plus alpha-lipoic acid 600 mg once daily, whereas Group B will receive duloxetine 60 mg once daily.","TREATMENT",{"masking":42,"maskingDescription":35,"whoMasked":43},"SINGLE",[44],"OUTCOMES_ASSESSOR","Painful diabetic peripheral neuropathy (PDPN) is a common and clinically important complication of diabetes mellitus, characterized by chronic neuropathic pain that can substantially impair physical functioning, sleep, daily activities, and quality of life. Duloxetine is an established pharmacological treatment for PDPN; however, the standard dose of 60 mg once daily may be associated with dose-related adverse effects and may not be well tolerated by all patients. Alpha-lipoic acid has antioxidant and neuroprotective properties and has also been studied as an adjunctive treatment for diabetic neuropathy.\n\nThis study is designed to evaluate whether a low-dose duloxetine regimen combined with alpha-lipoic acid provides pain relief that is not inferior to standard-dose duloxetine while maintaining an acceptable safety and tolerability profile. This will be a single-centre, parallel-arm, assessor-blinded, randomized controlled non-inferiority trial involving adults with painful diabetic peripheral neuropathy. Participants who meet the eligibility criteria and provide informed consent will be randomly allocated in a 1:1 ratio to one of two treatment groups.\n\nParticipants in Group A will receive duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily. Participants in Group B will receive duloxetine 60 mg once daily. During the first week, both groups will receive duloxetine 30 mg once daily. From Week 2 onward, Group A will continue duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily, whereas Group B will receive duloxetine 60 mg once daily.\n\nParticipants will be followed for 9 weeks. Telephone follow-ups will be conducted at Weeks 1 and 3 to assess safety and treatment adherence. Scheduled outpatient department visits will be conducted at Weeks 5 and 9 for clinical assessment and outcome evaluation. Paracetamol will be permitted as a protocol-specified rescue medication for breakthrough pain, and its use will be documented throughout the study.\n\nThe primary outcome will be the change in pain intensity measured by the Numerical Rating Scale (NRS) from baseline to Week 9. Secondary outcomes will include change in NRS at Week 5; Patient Global Impression of Change (PGIC) at Weeks 5 and 9; the proportion of participants achieving at least a 30% reduction in NRS from baseline; frequency and pattern of adverse effects; treatment tolerability; and treatment compliance.\n\nThe study will determine whether the low-dose duloxetine plus alpha-lipoic acid regimen is non-inferior to standard-dose duloxetine in reducing pain intensity in adults with PDPN, while also comparing safety, tolerability, adherence, and other clinical outcomes between the two treatment groups.",[47,54],{"label":48,"type":49,"description":50,"interventionNames":51},"Group A","EXPERIMENTAL","Duloxetine 30 mg once daily + Alpha-Lipoic Acid 600 mg once daily",[52,53],"Drug: Duloxetine","Drug: Alpha-Lipoic Acid",{"label":55,"type":56,"description":57,"interventionNames":58},"Group B","ACTIVE_COMPARATOR","Duloxetine 60 mg once daily",[52],[60,65],{"type":61,"name":62,"description":63,"armGroupLabels":64,"otherNames":35},"DRUG","Duloxetine","Duloxetine will be administered orally once daily. During Week 1, all participants will receive duloxetine 30 mg once daily. From Week 2 onward, participants in the low-dose combination group will continue duloxetine 30 mg once daily in combination with alpha-lipoic acid 600 mg once daily, whereas participants in the standard-dose duloxetine group will receive duloxetine 60 mg once daily. Treatment will continue through Week 9.",[48,55],{"type":61,"name":66,"description":67,"armGroupLabels":68,"otherNames":35},"Alpha-Lipoic Acid","Alpha-lipoic acid 600 mg will be administered orally once daily in combination with duloxetine 30 mg once daily to participants assigned to the low-dose combination group. Treatment will be administered from Week 2 through Week 9.",[48],[70],{"name":71,"role":72,"phone":73,"phoneExt":35,"email":74},"Md. Nazmul Hussain, MBBS","CONTACT","+8801715351491","nazmul1991@gmail.com",[76],{"facility":77,"status":35,"city":78,"state":35,"zip":79,"country":80,"countryCode":81,"cosmosGeoPoint":82,"geoPoint":87,"contacts":88},"Chittagong Medical College Hospital (CMCH)","Chittagong","4203","Bangladesh","BD",{"type":83,"coordinates":84},"Point",[85,86],91.83168,22.3384,{"lat":86,"lon":85},[89],{"name":71,"role":72,"phone":73,"phoneExt":35,"email":74},{"type":91,"investigatorFullName":92,"investigatorTitle":93,"investigatorAffiliation":5,"oldNameTitle":35,"oldOrganization":35},"PRINCIPAL_INVESTIGATOR","Dr. Md. Nazmul Hussain","MD Resident (Phase-B), Department of Neurology","100653258","efficacy-and-safety-of-low-dose-duloxetine-plus-alpha-lipoic-acid-versus-standard-dose-duloxetine-in-painful-diabetic-peripheral-neuropathy-100653258",false,"NCT07785544","Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy","Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy: An Assessor-Blinded Randomized Controlled Non-Inferiority Trial","Inclusion Criteria:\n\n* Age ≥18 years.\n* Diagnosed case of diabetes mellitus.\n* Diabetic peripheral neuropathy diagnosed clinically according to the Toronto Clinical Neuropathy Score (TCNS) criteria with a TCNS score ≥6, with painful neuropathy confirmed using the Leeds Assessment of Neuropathic Symptoms and Signs (LANSS) Pain Scale with a score ≥12.\n* Duration of neuropathic symptoms ≥3 months.\n* Baseline Numerical Rating Scale (NRS) pain score ≥4.\n* Willingness to participate in the study and provide written informed consent.\n\nExclusion Criteria:\n\n* Pain attributable to causes other than diabetic peripheral neuropathy, such as peripheral arterial disease (ischaemic pain), osteoarthritis, inflammatory arthritis, phantom limb pain, radiculopathy, or other chronic pain disorders.\n* Known vitamin B12 deficiency, hypothyroidism, chronic alcohol use, hereditary neuropathy, chemotherapy-induced neuropathy, HIV infection, or connective tissue disease.\n* Chronic kidney disease (CKD) stage ≥4.\n* Chronic liver disease or significant hepatic impairment (ALT \\>3 times the upper normal limit).\n* Use of antidepressants, antiepileptic drugs, sedatives, antipsychotic drugs, or opioids within the preceding 4 weeks.\n* Pregnancy or lactation, or women planning pregnancy during the study period.\n* Known hypersensitivity or contraindication to duloxetine or alpha-lipoic acid.\n* Major depressive disorder as assessed by the Patient Health Questionnaire-9 (PHQ-9), cognitive impairment (MMSE \\\u003C24), active malignancy, or any serious medical condition that, in the opinion of the investigator, may interfere with study participation, treatment adherence, or outcome assessment.","ALL","18 Years",{"count":104,"type":105},170,"ESTIMATED","INTERVENTIONAL",[108],"NA","This study will evaluate the efficacy and safety of low-dose duloxetine combined with alpha-lipoic acid compared with standard-dose duloxetine in adults with painful diabetic peripheral neuropathy. In this assessor-blinded, randomized, parallel-arm, non-inferiority trial, participants will be assigned in a 1:1 ratio to receive either duloxetine 30 mg once daily plus alpha-lipoic acid 600 mg once daily or duloxetine 60 mg once daily. The primary outcome will be the change in pain intensity measured by the Numerical Rating Scale from baseline to Week 9. Secondary outcomes will include changes in pain intensity at Week 5, Patient Global Impression of Change at Weeks 5 and 9, the proportion of participants achieving at least a 30% reduction in pain intensity, adverse effects, treatment tolerability and treatment compliance.",[111],"Painful Diabetic Peripheral Neuropathy","NOT_YET_RECRUITING","2026-08-21",{"date":115,"type":116},"2026-08-25","ACTUAL",{"date":115,"type":105},{"date":119,"type":105},"2027-08",{"name":5,"class":6},1]