Could a worm enzyme soothe diabetic nerve damage?
NCT ID NCT07475065
First seen Jun 24, 2026 · Last updated Jun 27, 2026 · Updated 2 times
Summary
This study tests whether an oral supplement called DLBS1033 (made from earthworm proteins) can reduce nerve damage symptoms in adults with diabetic polyneuropathy. Thirty-four people with type 2 diabetes will receive either the supplement or a placebo for 28 days, alongside standard care. Researchers will measure changes in neuropathy severity, inflammation, and nerve growth factors.
What this could mean
Our plain-language read of the trial. This is informational only, not medical advice or a prediction.
- Active substance
- DLBS1033 (lumbrokinase)
- What this could lead to
- If it works, this could point toward a new add-on treatment to ease nerve pain and improve nerve health in people with diabetic polyneuropathy.
- What could go wrong
- This is a small, early-phase trial with only 34 participants and a short 28-day treatment period. Results may not apply to everyone, and the supplement may not prove effective.
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 2/3
Runs two stages together: whether the treatment works, then large-scale confirmation.
- Participants
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About 34 people
The number the study aims to enrol. It can still change while the study runs.
- Expected to start
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Mar 2026
An estimate. Start dates often move.
- Expected to finish
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Jun 2026
An estimate. End dates often move.
- Lead sponsor
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Other sponsor
The registry's catch-all category, for sponsors it does not file as a company, a government agency, or a research network.
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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40 to 60 years
- Sex
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Anyone
- Healthy volunteers
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Not accepted
This study is not open to healthy volunteers. The entry requirements below say who it is open to.
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Copied word for word from the study's registry entry, so the wording is the study team's rather than ours.
Inclusion Criteria: * Adults aged 40-60 years diagnosed with diabetic polyneuropathy by a neurologist or neurology resident. * Patients with HbA1c levels between 7-10% within the past 30 days. * Willing to participate and able to sign the informed consent form. Exclusion Criteria: * Pregnant, breastfeeding, or planning pregnancy. * History of other neurological diseases such as stroke, myelopathy, alcoholic neuropathy, or compressive radiculopathy. * Significant renal impairment (creatinine \> 1.5× upper limit of normal), hepatic impairment (SGOT or SGPT \> 3× upper limit of normal), or severe cardiac disease (NYHA class III-IV heart failure). * History of alcohol consumption for ≥ 5 consecutive years. * Heavy smoker (Brinkman Index \> 600). * Known allergy or intolerance to DLBS1033. * Autoimmune disease, malignancy, or acute and/or chronic inflammatory conditions other than diabetic polyneuropathy. * Participation in another interventional pharmacological clinical study within 30 days prior to screening. * Currently taking anti-inflammatory and/or antioxidant medications.
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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 places running it
1 site. The list below names each one and where it is.
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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.
Contacts and locations
Locations
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Dr. Moewardi Regional General Hospital
Surakarta, Central Java, 57143, Indonesia
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- Can wearable sensors and walking tests reliably track nerve damage?
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