NCT07684625CompletedPhase 4
THE EFFECT OF LUMBRICUS RUBELLUS DLBS1033 EXTRACT IN PATIENTS WITH TYPE 2 DIABETES MELLITUS
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
Source: ClinicalTrials.gov · Last updated 6 Jul 2026
Brief summary (registry, in English)
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.
- Status (registry)
- Completed
- Phase (registry)
- Phase 4
- Study type
- Interventional
- Enrollment
- 60 (actual)
- First submitted
- 28 Jun 2026
- Start date
- 1 Mar 2026
- Primary completion date
- 21 Jun 2026
- Lead sponsor
- Universitas Sebelas Maret
- Diseases
- Type 2 diabetes
- NCT number
- NCT07684625
What you commit to
- Study type: Interventional · Phase 4
- Participants enrolled: 60
- From 1 Mar 2026 to the primary completion date, 21 Jun 2026
- 1 site in 1 country
- Visits and tests: ask the trial team, the registry does not list them
Built from the registry fields of ClinicalTrials.gov. It describes the study, not your situation.
Who cannot take part
Copied verbatim from ClinicalTrials.gov and grouped by topic. Only the trial team decides who can take part.
Other illness
- Patients with diabetic foot ulcer grade 1-2.
- Patients with Diabetic Kidney Disease (DKD) Stage 5.
- Patients with chronic liver disease.
- Patients with malignancy.
- Patients with autoimmune disease or active infection.
Other
- Post-operative patients.
- Non-compliant or uncooperative patients during the monitoring period.
Who the study is looking for
- Patients diagnosed with Type 2 Diabetes Mellitus currently on therapy.
- Patients receiving Lumbricus Rubellus extract therapy during outpatient care at the Endocrinology Clinic.
- Adults aged \>18 years, both male and female.
- Willing to undergo monthly evaluations during the 1-month study period
Age in the registry: 18 years to - · Sex: All · Does not accept healthy volunteers
Sites (1)
Sites in registry order. Pick your city on the disease page to sort them by distance.
| Site | City | Country | Site status |
|---|---|---|---|
| Dr. Moewardi Regional General Hospital Coordinator of this site? Confirm its status | Surakarta | Indonesia | Unknown status |
This page is information, not medical advice. Discuss any trial with your doctor.