New vitamin b shot with energy booster aims to soothe diabetic nerve pain
NCT ID NCT07296354
First seen Jun 27, 2026 · Last updated Jun 27, 2026
Summary
This study tests an injectable supplement that combines B vitamins with an energy molecule (ATP) to treat painful diabetic nerve damage. Two hundred adults with diabetes and nerve pain will receive either the ATP-enhanced shot or a standard B vitamin shot for 12 weeks. Researchers will measure changes in nerve pain symptoms and quality of life.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- ATP-containing vitamin B complex injection (Epinosine B Forte)
- What this could lead to
- If it works, this could offer a new option to ease nerve pain and improve quality of life for people with diabetic neuropathy.
- What could go wrong
- This is a phase 4 trial, but it hasn't started yet. The benefit over standard B vitamins may be small, and side effects like injection site reactions are possible.
This is an AI summary of the original study and may miss details. Read our disclaimer.
Study facts
What this study's own registry entry says, in plain language.
- Phase
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Phase 4
Runs after approval, following long-term safety and how well the treatment works in everyday use.
- Participants
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About 200 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Jan 2026
An estimate. Start dates often move.
- Expected to finish
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Jan 2029
An estimate. End dates often move.
- Lead sponsor
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A company
The lead sponsor is a pharmaceutical, biotech, or medical-device company.
Who can take part
This study's own entry requirements. Only the study team can say for certain whether you qualify.
- Ages
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18 to 70 years
- Sex
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Anyone
- Healthy volunteers
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Accepted
You do not need to have the condition being studied to take part.
Show the full entry requirements Hide the full entry requirements
Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: 1. Patients ≥ 18 years of age at time of consent 2. Able to provide informed consent for study participation. 3. Diagnosed with either Type 1 or Type 2 diabetes mellitus, with glycated hemoglobin (HbA1c) ≤ 10% 4. Diagnosed with diabetic polyneuropathy, defined as a Diabetic Neuropathy Symptom (DNS) score ≥ 2, with symptom duration of at least 3 months prior to providing informed consent. 5. Willingness to comply with study procedures and attend scheduled study visits 6. Patients should be on a stable antidiabetic medication regimen for 30 days prior to randomization. Exclusion Criteria: - 1. Non-diabetic causes of neuropathy, e.g., alcohol abuse, vitamin B12 deficiency, renal failure, or chemotherapy-induced neuropathy other diseases that causes presence of any severe pain associated with conditions other than DPN that may confuse or confound the assessment of neuropathic pain. 2. Current or recent (within 30 days from screening visit) use of Neuropathic pain treatments, including: 2.1 Gabapentinoids (gabapentin, pregabalin), 2.2Serotonin-norepinephrine reuptake inhibitors (duloxetine, venlafaxine, desvenlafaxine) 2.3 Tricyclic antidepressants (e.g., amitriptyline) 2.4 Topical capsaicin preparations 2.5 Carbamazepine, 2.6 Oxcarbazepine, 2.7 Lamotrigine 2.8 topiramate 2.9 other agents for neuropathic pain , Sedatives and anxiolytics (Benzodiazepines, Z-drugs (e.g., zolpidem), Barbiturates, Other B-complex or ATP-containing injectable supplements 2.10 Multivitamins or nutritional supplements 2.11 Pentoxifylline or Naftidrofuryl oxalate, Alpha-lipoic acid or other drug classes indicated for treatment of neuropathic pain. 3. Severe comorbidities (e.g., malignancy, liver failure, end-stage renal disease, decompensated heart failure) 4. Pregnancy or breastfeeding 5. Female patients of childbearing potential not using effective contraception (e.g., oral contraceptives, DMPA, IUD, double barrier, sterilization, or confirmed postmenopausal status) 6. Known hypersensitivity to any component of the investigational product 7. Participation in another clinical trial within the past 3 months
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Conditions
The condition(s) this trial relates to.
As listed by the trial registrant
The condition terms exactly as the trial's registrant entered them.
How to take part
Only the study team decides who joins. These are the ways to reach them.
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The official record
ClinicalTrials.gov lists the study team's own contact details, including names and phone numbers. We don't republish those.
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A doctor treating you
A doctor who knows your case can contact a study site on your behalf, and can tell you whether this study is worth pursuing at all.
More trials for these conditions
Other studies related to the condition(s) this trial covers.
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