An interventional study of Duloxetine and Alpha-Lipoic Acid in Painful Diabetic Peripheral Neuropathy, sponsored by Bangladesh Medical University. Not yet recruiting at 1 site in Bangladesh. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-08-26.
Sponsored by Bangladesh Medical University · Not applicable, Interventional, and Treatment
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.
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.
This 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.
Participants 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.
Participants 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.
The 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.
The 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.
Bangladesh Medical University is the lead sponsor of 43 studies on the registry; 26 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
ALT and AST (liver enzymes)
Two enzymes measured in a routine blood test of the liver. Higher levels can mean the liver is under strain or damaged. SGPT and SGOT are older names for ALT and AST.
Criteria usually give a limit as a multiple of the upper limit of normal (ULN), often higher when cancer has spread to the liver.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Hypersensitivity
An allergy, or another reaction of the immune system, to a substance. “Hypersensitivity to the study drug” means a known allergic reaction to it — not every side effect a medicine can have.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
MMSE and MoCA
Short tests of memory and thinking, each scored out of 30. Lower scores suggest more difficulty; criteria give a range, either to include people with memory problems or to leave them out.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Cancer (malignancy)
Malignancy means cancer. Criteria about another or earlier malignancy ask whether you have had a different cancer, usually within a set number of years.
Some are commonly allowed, such as treated skin cancers other than melanoma and early cancers removed completely — check the exceptions this study lists.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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 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
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.
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.
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.
Time frame: From baseline to Week 9
Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 5
Change in pain intensity from baseline to Week 5, 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.
Time frame: From baseline to Week 5
Patient Global Impression of Change (PGIC)
Patient-reported global assessment of change in painful diabetic peripheral neuropathy symptoms using the Patient Global Impression of Change (PGIC), a 7-point scale ranging from 1 (very much improved) to 7 (very much worse), with 4 indicating no change. Lower scores indicate greater improvement and therefore a better outcome.
Time frame: Week 5 and Week 9
Proportion of participants achieving ≥30% reduction in pain intensity
Proportion of participants achieving a ≥30% reduction 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. A reduction in NRS score indicates improvement.
Time frame: Week 5 and Week 9
Incidence, type, frequency, and severity of treatment-emergent adverse events
Type, frequency, and severity of adverse events occurring during the study period. Adverse events will be assessed and recorded from baseline through Week 9, including events leading to treatment discontinuation.
Time frame: Baseline to Week 9
Proportion of participants discontinuing treatment due to adverse events
Proportion of participants who discontinue study treatment because of adverse events occurring during the study period.
Time frame: Baseline to Week 9
Treatment compliance
Proportion of prescribed study medication doses taken during the study period.
Time frame: Baseline to Week 9
Plan to share: No
No publications or documents are linked to this record.
Start is estimated for Aug 2026; primary completion for Jun 2027, 10 months later.
How these figures are worked out, and which studies are left out of them.
This study is not yet recruiting, as verified in Aug 2026. You cannot join it, but the record below documents what was studied.
Get an email when the registry record changes — status, dates, results — or when someone posts here.
Sign in to followQuestions and observations about this study, from anyone following it. Not medical advice, and not a channel to the study team — their contact details are on the registry record.
Sign in to join the discussion. Reading takes no account; posting does. You choose a display name, and a pseudonym is the default.
Nothing here yet. If you are running this trial, taking part in it, or weighing whether to, this is the place to say so.
Studies of the drug tested here: Thioctic Acid
Bangladesh Medical University