The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy

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.

NCT Number	NCT07475065
Lead Sponsor	Universitas Sebelas Maret Collaborators: Dexa Medica Group
Conditions	Diabetic Polyneuropathy, Peripheral Nervous System Diseases, Peripheral Neuropathy, Diabetes Mellitus
Enrollment	34 participants
Start Date	2026-03-01
Primary Completion	2026-05-31 (estimated)
Study Completion	2026-06-30 (estimated)
Updated on ClinicalTrials.gov	2026-03-16