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Study of the effectiveness and safety of alpha-lipoic acid and benfotiamine for the treatment of symptoms in patients with diabetic neuropathy

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What is this study about?

This study focuses on Diabetic sensorimotor polyneuropathy, a condition involving nerve damage caused by diabetes that typically results in symptoms like pain, numbness, or tingling in the hands and feet. The purpose of the study is to evaluate the effectiveness and safety of a combined treatment compared to using single medications alone. Participants will receive one of three different treatment options consisting of benfotiamine, thioctic acid, or a combination of both substances.

The study involves the use of benfotiamine, which is taken as an oral tablet, and thioctic acid, also known as alpha-lipoic acid. One group will take the combination of these two substances, while other groups will take the individual medications to compare their effects. The medications used for comparison include Benfogamma Forte and Thiogamma.

During the study, individuals will follow a treatment plan for a period of 16 weeks. The process is designed to be double-blind, meaning that neither the participants nor the researchers know which specific treatment is being administered to each person. This helps to ensure that the results are objective and not influenced by expectations.

Who Can Join the Study?

  • You must provide written informed consent, which means signing a document that states you understand the study and agree to take part before any tests begin.
  • You must have a diagnosis of mild to moderate diabetic sensorimotor polyneuropathy (DSPN), which is nerve damage caused by diabetes that affects how you feel sensations in your body.
  • Your nerve tests must show issues with the sural nerve, which is a specific nerve in the lower leg that carries sensation.
  • You must have specific nerve symptoms and signs, measured by specialized questionnaires called NTSS-6 and NDS.
  • Your HbA1c level, which is a blood test that shows your average blood sugar levels over the past few months, must be 9.5% or lower.
  • You must be willing to avoid changing your diet or lifestyle, such as starting new weight-loss medications, during the study.
  • You must be able to complete a baseline symptom assessment, which is a record of your symptoms, for seven days in a row using a digital link.
  • You must be able to follow the rules and restrictions of the study.
  • You must be able to travel to the study site for your scheduled appointments.
  • You must have a way to receive SMS, which are text messages on a mobile phone.
  • You must be 18 years of age or older.
  • You must have been diagnosed with type 1 or type 2 diabetes at least one year before the study begins.
  • Your diabetes medications or insulin doses must be stable, meaning they have not changed significantly in the last 3 months.
  • If you take SGLT-2 inhibitors (a type of diabetes medication), you must have been taking them for at least 26 weeks.
  • Your blood sugar metabolism must be stable, meaning you have not had serious complications like hypoglycaemia (dangerously low blood sugar causing unconsciousness), hyperosmolar hyperglycemic state (extremely high blood sugar), or ketoacidosis (a serious buildup of acids in the blood) in the last 3 months.
  • You must have persistent or recurrent neuropathic symptoms, such as numbness, tingling, burning, or stabbing pain, that have occurred within the last 3 months.

Who Cannot Join the Study?

  • Women who could become pregnant and are not using a reliable birth control method (such as birth control pills, an intrauterine device, or using condoms) for at least 2 months before joining the study.
  • Use of GLP-RA (a type of medication used to manage blood sugar) within the last 12 months.
  • Use of any pain medication for chronic pain within the last 2 months, except for specific allowed doses of gabapentin, pregabalin, or duloxetine that have not changed recently.
  • Taking pain relief like ibuprofen or paracetamol for more than 7 days in a row, or using low-dose aspirin for blood thinning.
  • Having any allergy or known sensitivity to the medications used in the study.
  • Significant liver disease, which is measured by high levels of certain enzymes (AST or ALT) in the blood.
  • Significant kidney disease, measured by a low eGFR (a value that shows how well your kidneys filter waste from your blood).
  • Uncontrolled high blood pressure (hypertension), where the top number is higher than 160 or the bottom number is higher than 100.
  • Having a major heart attack (myocardial infarction), a stroke, or cancer (malignant disease) within the last 12 months.
  • Having severe or unstable depression or other mental health conditions that could affect the study results.
  • Currently taking antidepressants, unless it is a stable dose of duloxetine or selective serotonin reuptake inhibitors (a common type of antidepressant).
  • Having any other medical condition that the doctor believes might interfere with the study measurements.
  • Having nerve damage (neuropathy) caused by something other than diabetes, such as vitamin B12 deficiency, chemotherapy, or autoimmune issues (where the body attacks itself).
  • Having muscle disease (myopathy) or other nervous system diseases.
  • Current or past alcohol abuse, defined as drinking more than 24 units a week for men or 12 units a week for women.
  • Current or past regular use of recreational drugs, except for occasional or experimental use of cannabis without signs of addiction.
  • Taking part in another clinical trial (medical research study) within the last 2 months.
  • Living in the same house as someone else who is also participating in this study.
  • Being pregnant or breastfeeding at the time of screening.
  • Having severe chronic pain from a cause other than diabetes, such as fibromyalgia (a condition causing widespread muscle pain).
  • Having both legs amputated above the ankle.
  • Having a history of heart, lung, stomach, blood, or hormone diseases, or cancer, that could cause nerve pain or symptoms.
  • Having a very high pain level (higher than a 9 out of 10) on a NRS (a scale used to measure how much pain you feel) during the last 4 weeks.
  • Having a magnesium deficiency that cannot be corrected before starting the study.
  • Taking supplements such as B-vitamins, antioxidants, or evening primrose oil for 5 days or longer within the last 2 months.
  • Using electrical nerve stimulation, muscle stimulation, or capsaicin patches (heat-based pain patches) within the last 2 months.

Where you can join this trial?

Verified and Recommended Sites

No sites found in this category

Verified Sites

Site Name City Country Status
Geomedical Kft. Budapest Hungary

Other Sites

Site Name City Country Status
Del-Budai Centrumkorhaz Szent Imre Egyetemi Oktatokorhaz Budapest Hungary
BKS Research Kft. Hatvan Hungary
University Of Debrecen Debrecen Hungary
IPR Hungary Kft. Miskolc Hungary
Semmelweis University Budapest Hungary
Gyongyosi Bugat Pal Korhaz Gyongyos Hungary
Bekes Varmegyei Koezponti Korhaz Gyula Hungary
University Of Szeged Szeged Hungary
Budapesti Uzsoki Utcai Korhaz Budapest Hungary

Want to learn more about this study or check if you can participate? Contact us.

Trial status

Country Status Recruitment Start
Hungary Hungary
Not yet recruiting
01.03.2026

Trial locations

Investigated drugs:

Benfotiamine is a form of vitamin B1 that is being tested to see how well it helps treat the symptoms of nerve damage caused by diabetes.

Alpha-lipoic acid is an antioxidant used in this study to help manage the symptoms associated with diabetic nerve damage.

Diabetic sensorimotor polyneuropathy – This condition is a type of nerve damage that occurs as a complication of diabetes. It primarily affects the peripheral nerves, which are responsible for carrying signals between the body and the brain. The damage typically begins in the longest nerves, often starting in the feet. Over time, it can spread to the hands and legs. This progression causes changes in how people feel sensations or move their limbs.

Trial ID:
2025-521985-82-00
Protocol code:
WOE-DE-2023-2
Trial Phase:
Therapeutic exploratory (Phase II)

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