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.
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.
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.
Universitas Sebelas Maret
Lead sponsor
Dexa Medica Group
Collaborator