The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy

NCT07475065 | Not Yet Recruiting Phase 2 DMC

• 1 other identifier: DLBS1033DPN
• Study Type: interventional
• Target: 34
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Diabetic Polyneuropathy; Peripheral Nervous System Diseases; Peripheral Neuropathy; Diabetes Mellitus

Keywords

DLBS1033; lumbrokinase; diabetic polyneuropathy; peripheral neuropathy; Toronto Clinical Neuropathy Score; TNF-α; TNF-alpha; Nerve Growth Factor; sural nerve; nerve conduction study; NCS; EMG; ENMG; Electromyography

Outcome Measures

Primary Outcomes (1)

• 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.

  Baseline and Day 28

Secondary Outcomes (4)

• Change in Tumor Necrosis Factor-α (TNF-α) Level

  Baseline and Day 28

• Change in Nerve Growth Factor (NGF) Level

  Baseline and Day 28

• Change in Sensory Nerve Conduction Velocity of the Sural Nerve

  Baseline and Day 28

• Change in Sural Sensory Nerve Amplitude

  Baseline and Day 28

Study Arms (2)

Experimental: DLBS1033 + Standard Therapy

EXPERIMENTAL

Participants receive oral DLBS1033 as adjuvant therapy in addition to standard therapy for diabetic polyneuropathy. Intervention 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).

Drug: DLBS1033; Drug: Placebo Comparator: Placebo + Standard Therapy

Placebo Comparator: Placebo + Standard Therapy

PLACEBO COMPARATOR

Participants 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).

Drug: DLBS1033; Drug: Placebo Comparator: Placebo + Standard Therapy

Interventions

DLBS1033 DRUG

Intervention 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).

Also known as: lumbrokinase

Experimental: DLBS1033 + Standard Therapy; Placebo Comparator: Placebo + Standard Therapy

Placebo Comparator: Placebo + Standard Therapy DRUG

Participants 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).

Experimental: DLBS1033 + Standard Therapy; Placebo Comparator: Placebo + Standard Therapy

Eligibility Criteria

• Age: 40 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

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.

Sponsors & Collaborators

• Universitas Sebelas Maret: lead
• Dexa Medica Group: collaborator

Study Sites (1)

Dr. Moewardi Regional General Hospital

Surakarta, Central Java, 57143, Indonesia

Location

MeSH Terms

Conditions

Diabetic Neuropathies; Peripheral Nervous System Diseases; Diabetes Mellitus; Hereditary Sensory and Autonomic Neuropathies

Interventions

DLBS 1033; lumbrokinase; Standard of Care

Condition Hierarchy (Ancestors)

Neuromuscular Diseases; Nervous System Diseases; Diabetes Complications; Endocrine System Diseases; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Nervous System Malformations; Heredodegenerative Disorders, Nervous System; Neurodegenerative Diseases; Polyneuropathies; Congenital Abnormalities; Congenital, Hereditary, and Neonatal Diseases and Abnormalities; Genetic Diseases, Inborn

Intervention Hierarchy (Ancestors)

Quality Indicators, Health Care; Quality of Health Care; Health Services Administration; Health Care Quality, Access, and Evaluation

Study Officials

• Krisandi Hartanto, MD

  Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Krisandi Hartanto, MD

CONTACT

+6281256081415; krisandyhartanto@yahoo.com

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: CARE PROVIDER
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: MD

Study Record Dates

• First Submitted: February 25, 2026
• First Posted: March 16, 2026
• Study Start: March 1, 2026
• Primary Completion: May 31, 2026
• Study Completion (Estimated): June 30, 2026
• Last Updated: March 16, 2026

Record last verified: 2026-03

Locations

ID (1)