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The Effect of Oral DLBS1033 in Patients With Diabetic Polyneuropathy

StatusNot Yet Recruiting
PhasePhase 2/3
Started
View on ClinicalTrials.gov ↗
Record status
This record was last updated March 16, 2026 (before its estimated May 31, 2026 completion). Its status may not reflect the trial's current state.

Record History

  1. Minor Study First Submitted
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.
Trial Details
NCT Number NCT07475065
Lead Sponsor Universitas Sebelas Maret
Collaborators: Dexa Medica Group
Conditions
(from sponsor)
Diabetic Polyneuropathy, Peripheral Nervous System Diseases, Peripheral Neuropathy, Diabetes Mellitus
Related terms Diabetes Mellitus, Diabetic Neuropathies, Hereditary Sensory and Autonomic Neuropathies, Peripheral Nervous System Diseases
Enrollment 34 participants
Start Date
Primary Completion (estimated)
Study Completion (estimated)
Updated on ClinicalTrials.gov