Clinical Research Directory
Browse clinical research sites, groups, and studies.
THE EFFECT OF LUMBRICUS RUBELLUS DLBS1033 EXTRACT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Sponsor: Universitas Sebelas Maret
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.
Official title: THE EFFECT OF LUMBRICUS RUBELLUS DLBS1033 EXTRACT ON LEVELS OF HIGH-SENSITIVITY C-REACTIVE PROTEIN, VASCULAR ENDOTHELIAL GROWTH FACTOR, AND QUALITY OF LIFE IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
60
Start Date
2026-03-01
Completion Date
2026-06-28
Last Updated
2026-07-06
Healthy Volunteers
No
Conditions
Interventions
Oral Lumbricus Rubellus DLBS1033 (Low Dose)
DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 3×1 tablet t.i.d. for 4 weeks
Oral Lumbricus Rubellus DLBS1033 (High Dose)
DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 3×2 tablets t.i.d. for 4 weeks
Standard Diabetes Mellitus Therapy
Standard Diabetes Mellitus Therapy
Locations (1)
Dr. Moewardi Regional General Hospital
Surakarta, Central Java, Indonesia