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The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy
Sponsor: Universitas Sebelas Maret
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.
Official title: The Effect of Oral DLBS1033 as Adjuvant Therapy on Inflammatory Biomarkers, Neuroregeneration Biomarkers, and Disease Severity in Patients With Diabetic Polyneuropathy: A Randomized Controlled Trial (An Evaluation of Changes in TCNS, TNF-α, NGF, and Sensory Nerve Conduction Study of the Sural Nerve)
Key Details
Gender
All
Age Range
40 Years - 60 Years
Study Type
INTERVENTIONAL
Enrollment
34
Start Date
2026-03-01
Completion Date
2026-06-30
Last Updated
2026-03-16
Healthy Volunteers
No
Conditions
Interventions
DLBS1033
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).
Placebo Comparator: Placebo + Standard Therapy
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).
Locations (1)
Dr. Moewardi Regional General Hospital
Surakarta, Central Java, Indonesia