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

NCT07785544 · Status: NOT_YET_RECRUITING · Phase: NA · Type: INTERVENTIONAL · Enrollment: 170

Last updated 2026-08-26

No results posted yet for this study

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

Interventions

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.

DRUG

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.

Sponsors & Collaborators

  • Bangladesh Medical University

    lead OTHER

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
SINGLE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-08-25
Primary Completion
2027-06-30
Completion
2027-08-31

Countries

  • Bangladesh

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07785544 on ClinicalTrials.gov