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Worm extract shows promise for diabetic nerve pain

NCT ID NCT07683598

Symptom relief Sponsor: RS H Adam Malik Source: ClinicalTrials.gov ↗

What the study statuses mean

This study's is highlighted.

Recruitment status, easiest to join first

Recruiting now
This trial is taking on new participants right now.
Not yet recruiting This study
Registered, but not yet taking participants.
By invitation only
Not open to general applications. Only people the study team invites can take part.
Paused
Paused for now. It may or may not start again.
Ongoing
Running, but no longer taking on new participants.
Completed
The trial has finished. Results may not be published yet.
Stopped early
Stopped early, before it reached the end. That can be for many reasons, including safety.
Cancelled
Cancelled before anyone took part.

Expanded access (not trials)

Expanded access
Not a trial. This treatment can be requested outside a study, case by case, for people who qualify.
Expanded access (paused)
Not a trial. The treatment can normally be requested outside a study, but is unavailable right now.
Expanded access (ended)
Not a trial. The treatment could once be requested outside a study, but no longer can.
Approved
The treatment has been approved, so it is available normally rather than through this programme.

When the status isn't known

Details not published
The full record has not been published yet, so there is little to show here.
Status unknown
This status has not been confirmed recently, so it may be out of date.

First seen Jul 06, 2026 · Last updated Jul 07, 2026 · Updated 1 time

Summary

This study tests whether a supplement called DLBS1033, made from earthworm extract, can improve nerve function and reduce symptoms in people with diabetic neuropathy. Participants take either the supplement or a placebo alongside their usual treatment for 12 weeks. Researchers measure nerve speed, symptom scores, and quality of life to see if the extract provides extra benefit.

What this could mean

Our plain-language read of the trial. This is informational only, not medical advice or a prediction.

Active substance
DLBS1033 (Lumbricus rubellus extract)
What this could lead to
If it works, this could offer a new add-on option to help ease nerve damage symptoms and improve quality of life for people with diabetic neuropathy.
What could go wrong
This is a small, early-stage trial with 80 participants. The supplement may show no benefit over placebo, and results may not apply to everyone with diabetic neuropathy.

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

Not a phased trial

Phase numbers describe drug development. The registry uses this when they do not apply, as it does for trials of devices, procedures or behaviour changes, and for observational studies.

Participants

About 80 people

The number the study aims to enrol. It can still change while the study runs.

Expected to start

Aug 2026

An estimate. Start dates often move.

Expected to finish

Mar 2027

An estimate. End dates often move.

Lead sponsor

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

18 years and older

Sex

Anyone

Healthy volunteers

Not accepted

This study is not open to healthy volunteers. The entry requirements below say who it is open to.

Show 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: * Patients diagnosed with diabetic neuropathy based on symptoms and clinical signs of peripheral neuropathy and a Toronto Clinical Neuropathy Score (TCNS) of 6 or higher, representing mild to severe neuropathy. * Age 18 years or older. * Willing to participate in the study and sign the informed consent form. * Able to complete the study procedures and complete the Short Form-36 quality of life questionnaire independently or with assistance from the investigator if needed. Exclusion Criteria: * Participants with other conditions that may cause non-diabetic peripheral neuropathy, including history of chemotherapy, use of anti-tuberculosis drugs such as isoniazid, heavy alcohol consumption, chronic kidney disease, liver cirrhosis, vitamin B12 deficiency, hypothyroidism, HIV/AIDS, hereditary neuropathy, or neuromuscular disease affecting the peripheral nerves. * Participants with acute infection or active inflammatory conditions that may affect interleukin-8 and Galectin-3 levels at the time of sample collection before or after intervention, such as acute infection with fever, infection with systemic manifestations, active malignancy, or active inflammatory autoimmune disease. * Allergy or history of hypersensitivity to the active ingredient of DLBS1033. * Currently receiving another experimental therapy or participating in another clinical study. * Pregnant or breastfeeding women.

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Conditions

The condition(s) this trial relates to.

diabetic neuropathy

As listed by the trial registrant

The condition terms exactly as the trial's registrant entered them.

Diabetic neuropathy

How to take part

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  1. The places running it

    1 site. The list below names each one and where it is.

  2. 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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  3. A doctor treating you

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Contacts and locations

Locations

  • RS H Adam Malik

    Medan, North Sumatera, 20136, Indonesia

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