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

NCT07785544 | Not Yet Recruiting

• 1 other identifier: 59.127.1557.13.19.PG.2026.1416
• Study Type: interventional
• Target: 170
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Painful Diabetic Peripheral Neuropathy

Outcome Measures

Primary Outcomes (1)

• Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 9

  Change in pain intensity from baseline to Week 9, measured using the Numerical Rating Scale (NRS), a 0-10 scale in which 0 indicates no pain and 10 indicates the worst possible pain. Higher scores indicate worse pain and therefore a worse outcome.

  From baseline to Week 9

Secondary Outcomes (6)

• Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 5

  From baseline to Week 5

• Patient Global Impression of Change (PGIC)

  Week 5 and Week 9

• Proportion of participants achieving ≥30% reduction in pain intensity

  Week 5 and Week 9

• Incidence, type, frequency, and severity of treatment-emergent adverse events

  Baseline to Week 9

• Proportion of participants discontinuing treatment due to adverse events

  Baseline to Week 9

Study Arms (2)

Duloxetine 30 mg + Alpha-Lipoic Acid 600 mg

EXPERIMENTAL

Duloxetine 30 mg will be administered orally once daily throughout the treatment period. Alpha-lipoic acid 600 mg will be administered orally once daily from Week 2 through Week 9.

Drug: Duloxetine; Drug: Alpha-Lipoic Acid

Duloxetine 60 mg

ACTIVE COMPARATOR

Duloxetine 30 mg will be administered orally once daily during Week 1, followed by duloxetine 60 mg orally once daily from Week 2 through Week 9.

Drug: Duloxetine

Interventions

Duloxetine DRUG

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.

Duloxetine 30 mg + Alpha-Lipoic Acid 600 mg; Duloxetine 60 mg

Alpha-Lipoic Acid DRUG

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.

Duloxetine 30 mg + Alpha-Lipoic Acid 600 mg

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• Bangladesh Medical University: lead

Study Sites (1)

Chittagong Medical College Hospital (CMCH)

Chittagong, 4203, Bangladesh

Location

MeSH Terms

Interventions

Duloxetine Hydrochloride; Thioctic Acid

Intervention Hierarchy (Ancestors)

Thiophenes; Sulfur Compounds; Organic Chemicals; Heterocyclic Compounds, 1-Ring; Heterocyclic Compounds; Carboxylic Acids; Coenzymes; Enzymes and Coenzymes; Fatty Acids; Lipids

Central Study Contacts

Md. Nazmul Hussain, MBBS

CONTACT

+8801715351491; nazmul1991@gmail.com

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD Resident (Phase-B), Department of Neurology

Model Details: 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.

Study Record Dates

• First Submitted: August 21, 2026
• First Posted: August 25, 2026
• Study Start: August 25, 2026
• Primary Completion (Estimated): June 1, 2027
• Study Completion (Estimated): August 1, 2027
• Last Updated: August 26, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

BA (1)