Clinical Trial

THE EFFECT OF LUMBRICUS RUBELLUS DLBS1033 EXTRACT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS

Completed Phase 4
View on ClinicalTrials.gov →
Summary
This randomized, open-label, controlled trial aims to evaluate the effect of oral Lumbricus Rubellus extract DLBS1033 as adjunctive therapy on inflammatory biomarker (hs-CRP), angiogenic factor (VEGF), and quality of life in patients with Type 2 Diabetes Mellitus. Sixty eligible patients attending the Endocrinology Outpatient Clinic of RSUD Dr. Moewardi Surakarta will be randomized into three groups: two intervention groups receiving standard DM therapy combined with DLBS1033 (490 mg t.i.d. as either 3×1 tablet or 3×2 tablets daily) and one control group receiving standard DM therapy alone, over a 4-week observation period from May to June 2026. Primary outcomes include changes in serum hs-CRP and VEGF levels; secondary outcome is health-related quality of life assessed by EQ-5D-5L.
Trial Details
NCT Number NCT07684625
Lead Sponsor Universitas Sebelas Maret
Conditions Diabetes Mellitus, Type 2
Enrollment 60 participants
Start Date 2026-03-01
Primary Completion 2026-06-21 (estimated)
Study Completion 2026-06-28 (estimated)
Updated on ClinicalTrials.gov 2026-07-06