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

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.

Timeline

Start

2026-03-01

Primary completion

2026-06-21

Completion

2026-06-28

Publications

• Background Dewi NWS, Mahendra AN. The in-vivo anti-inflammatory effect of red earthworm (Lumbricus Rubellus) ethanolic extract from organic farmland in Bali, Indonesia. Bali Med J 2020;9(3):652-655
• Background Öz S, Özden H, Yıldız F, et al. Protective effect of Lumbricus Rubellus Hoffmeister extract in experimental renal ischemia/reperfusion injury in the nephrectomy rats. INDIAN J Exp Biol 2023;61(December)
• Background Semih Oz, Yildiz F, Senturk H, et al. Protective Effects of Lumbricus Extract on the Antioxidant System and Liver in an Experimentally Created Liver Ischemia Reperfusion Injury Model in Rats. Biol Bull 2023;50(3):276-283

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Indications