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.
Parallel
DLBS1033
DrugIntervention Drug: DLBS1033 Dose: 980 mg orally, three times daily Duration: 28 days Description: DLBS1033 contains lumbrokinase (Lumbricus low-molecular-weight proteins) with anti-inflammatory, fibrinolytic, and neuroregenerative activity. Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).
Placebo Comparator: Placebo + Standard Therapy
DrugParticipants receive placebo capsules identical in appearance to DLBS1033, in addition to standard therapy. Intervention Drug: Placebo Dose: Matching placebo, orally, three times daily Duration: 28 days Other Components: Standard therapy for diabetic polyneuropathy (per treating physician).
Change in Toronto Clinical Neuropathy Score (TCNS)
TCNS is a validated clinical scoring system that assesses neuropathy severity based on symptoms, sensory testing, and reflex examination, with the minimum value of 0 and maximum value of 19 points. A decrease in TCNS indicates improvement in neuropathy severity.
Change in Tumor Necrosis Factor-α (TNF-α) Level
Serum TNF-α concentration measured using ELISA to evaluate changes in systemic inflammation, reported in pg/mL. A reduction indicates decreased inflammatory activity.
Change in Nerve Growth Factor (NGF) Level
Serum NGF concentration measured using ELISA to assess neuroregeneration activity, reported in pg/mL. An increase indicates improved neurotrophic support.
Change in Sensory Nerve Conduction Velocity of the Sural Nerve
Sensory nerve conduction study assessing sural nerve conduction velocity, measured in m/s. Improvement reflects better peripheral nerve function.
Change in Sural Sensory Nerve Amplitude
Sensory nerve conduction study assessing sural nerve amplitude, measured in µV. Improvement reflects better peripheral nerve function.
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Universitas Sebelas Maret
Lead sponsor
Dexa Medica Group
Collaborator
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