The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy

Starting soon · Phase 2/Phase 3 · Has a placebo group

Conditions studied: Diabetic Polyneuropathy, Peripheral Nervous System Diseases, Peripheral Neuropathy, Diabetes Mellitus

In brief

This study aims to evaluate whether oral DLBS1033 can improve clinical symptoms and biological markers of nerve damage in adults with diabetic polyneuropathy. The trial enrolls patients with type 2 diabetes who show clinical signs of peripheral nerve injury. Participants will receive either DLBS1033 as adjuvant therapy or standard therapy alone for 28 days. The study will compare changes in neuropathy severity (Toronto Clinical Neuropathy Score), inflammatory biomarkers (TNF-α), neuroregeneration biomarkers (Nerve Growth Factor), and sensory nerve conduction parameters of the sural nerve between the two groups. Blood tests, clinical assessments, and nerve conduction studies will be performed at baseline and follow-up visits. Participants will also report any symptoms or adverse events throughout the study.

Key facts

Study ID

NCT07475065

Run by

Universitas Sebelas Maret

People needed

34

Starts

2026-03-01

Expected to finish

2026-06-30

Last updated by the study team

2026-03-16

Who can join

Age: 40 and older, up to 60. Sex: any. Healthy volunteers: not accepted.

You may qualify if…

• 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.

You may not qualify if…

• 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.

Where it is running

• Dr. Moewardi Regional General Hospital — Surakarta, Central Java, Indonesia

Full record on ClinicalTrials.gov

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