Painful Diabetic Peripheral NeuropathyNCT07785544
Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy
A study testing Duloxetine and Alpha-Lipoic Acid in people with Painful Diabetic Peripheral Neuropathy, run by Bangladesh Medical University at 1 site in Bangladesh.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Painful Diabetic Peripheral Neuropathy
- What is being tested?
- Duloxetine and Alpha-Lipoic Acid
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 170 participants
- Where
- 1 siteBangladesh
- Study dates
- 25 Aug 2026to Aug 2027
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site
Chittagong Medical College Hospital (CMCH)
Chittagong, 4203
Md. Nazmul Hussain, MBBS, +8801715351491, nazmul1991@gmail.com
About this study
Official title: Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy: An Assessor-Blinded Randomized Controlled Non-Inferiority Trial
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.
Read the detailed description
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.
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Being tested
- Duloxetine, Alpha-Lipoic Acid
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
DuloxetineDrug
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 AcidDrug
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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: 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. Receives: Drug: Duloxetine |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: From baseline to Week 9
Secondary outcomes (6)
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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: 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.
Measured: Baseline to Week 9
Treatment compliance
Proportion of prescribed study medication doses taken during the study period.
Measured: Baseline to Week 9
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted25 Aug 2026
- Study start25 Aug 2026 (estimated)
- Primary completionJun 2027 (estimated)
- Study completionAug 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Painful Diabetic Peripheral NeuropathyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- 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.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 170 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Bangladesh Medical University
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Dr. Md. Nazmul Hussain, Bangladesh Medical University
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07785544
- Sponsor's protocol ID
- 59.127.1557.13.19.PG.2026.1416
- Status last verified
- Aug 2026
- First submitted
- 21 Aug 2026
- Last updated
- 26 Aug 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No
Study at a glance
From the registry record, last updated by the sponsor on 26 Aug 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy and Safety of Low-Dose Duloxetine Plus Alpha-Lipoic Acid Versus Standard-Dose Duloxetine in Painful Diabetic Peripheral Neuropathy: An Assessor-Blinded Randomized Controlled Non-Inferiority Trial
- ClinicalTrials.gov ID
- NCT07785544
- Acronym / sponsor ID
- 59.127.1557.13.19.PG.2026.1416
- Conditions
- Painful Diabetic Peripheral Neuropathy
- Study type
- Interventional
- Recruitment status
- Not yet recruiting
- Enrolment
- 170 participants (estimated)
- Lead sponsor
- Bangladesh Medical UniversityUniversity, hospital or other
- Study start
- 25 Aug 2026 (estimated)
- Primary completion
- Jun 2027 (estimated)
- Study completion
- Aug 2027 (estimated)
- First posted
- 25 Aug 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- 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.
| Arm | Type | Receives |
|---|---|---|
| Duloxetine 30 mg + Alpha-Lipoic Acid 600 mg | Experimental | Drug: Duloxetine, Drug: Alpha-Lipoic AcidDuloxetine 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. |
| Duloxetine 60 mg | Active comparator | Drug: DuloxetineDuloxetine 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (8 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| DuloxetineDuloxetine 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 | Duloxetine 30 mg + Alpha-Lipoic Acid 600 mg, Duloxetine 60 mg |
| Alpha-Lipoic AcidAlpha-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. | Drug | Duloxetine 30 mg + Alpha-Lipoic Acid 600 mg |
Primary outcome
Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 9
Time frame: 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.
6 secondary outcomes
Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 5
Time frame: From baseline to Week 5
Patient Global Impression of Change (PGIC)
Time frame: Week 5 and Week 9
Proportion of participants achieving ≥30% reduction in pain intensity
Time frame: Week 5 and Week 9
Incidence, type, frequency, and severity of treatment-emergent adverse events
Time frame: Baseline to Week 9
Proportion of participants discontinuing treatment due to adverse events
Time frame: Baseline to Week 9
Treatment compliance
Time frame: Baseline to Week 9
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 26 Aug 2026.
- Individual participant dataSharing planned: No
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Duloxetine and Alpha-Lipoic Acid in people with Painful Diabetic Peripheral Neuropathy, run by Bangladesh Medical University at 1 site in Bangladesh.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 8 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: opening soon, as of the sponsor's last update on 26 Aug 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Bangladesh. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Md. Nazmul Hussain, MBBS (+8801715351491, nazmul1991@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in pain intensity measured by Numerical Rating Scale (NRS) from baseline to Week 9 (time frame: From baseline to Week 9). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 26 Aug 2026.