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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