Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy

NCT ID
NCT07785544
Registry status
Not yet recruiting
Study type
Not specified in the registry data
Phase
Not applicable
Sponsor
Bangladesh Medical University

Overview

ClinicalTrials.gov lists this study as Not yet recruiting.

Enrollment: 170 participants (Estimated).

What is being studied

No interventions are listed in the registry data.

Who may be eligible

Ages
Not specified in the registry data
Sex
Not specified in the registry data
Healthy volunteers accepted
No

ClinicalTrials.gov lists the following eligibility criteria.

Inclusion Criteria: * Age ≥18 years. * Diagnosed case of diabetes mellitus. * 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. * Duration of neuropathic symptoms ≥3 months. * Baseline Numerical Rating Scale (NRS) pain score ≥4. * Willingness to participate in the study and provide written informed consent. Exclusion Criteria: * 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. * Known vitamin B12 deficiency, hypothyroidism, chronic alcohol use, hereditary neuropathy, chemotherapy-induced neuropathy, HIV infection, or connective tissue disease. * Chronic kidney disease (CKD) stage ≥4. * Chronic liver disease or significant hepatic impairment (ALT \>3 times the upper normal limit). * Use of antidepressants, antiepileptic drugs, sedatives, antipsychotic drugs, or opioids within the preceding 4 weeks. * Pregnancy or lactation, or women planning pregnancy during the study period. * Known hypersensitivity or contraindication to duloxetine or alpha-lipoic acid. * Major depressive disorder as assessed by the Patient Health Questionnaire-9 (PHQ-9), cognitive impairment (MMSE \<24), active malignancy, or any serious medical condition that, in the opinion of the investigator, may interfere with study participation, treatment adherence, or outcome assessment.

Study locations

1 study location is listed.

Site recruitment status is not specified in the registry data for these locations.

Countries: Bangladesh

Sample of listed locations

  • Chittagong Medical College Hospital (CMCH) — Chittagong, 4203, Bangladesh — Site recruitment status not specified in the registry data

Study details

Start date
August 25, 2026
Primary completion date
June 1, 2027
First posted
August 25, 2026

Source and update information

Source
ClinicalTrials.gov
NCT ID
NCT07785544
Registry last updated
August 26, 2026
QualifiedStudies registry data refreshed
September 21, 2026

View NCT07785544 on ClinicalTrials.gov

Trial information can change. Confirm current study details with the study team or the registry.

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