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

NCT07684625 | Completed Phase 4 DMC

• 1 other identifier: DLBS1033 on Diabetes Mellitus
• Study Type: interventional
• Target: 60
• Locations: 1 country
• Sites: 1

Brief 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.

Conditions

Diabetes Mellitus, Type 2

Keywords

High-Sensitivity; C-Reactive Protein; Diabetes Mellitus Type 2; Vascular Endothelial Growth Factor; Quality of Life; Oral Lumbrokinase; DLBS1033; EQ-5D-5L

Outcome Measures

Primary Outcomes (2)

• hs-CRP (High-sensitivity C-Reactive Protein)

  Serum hs-CRP levels measured using immunoturbidimetric method at baseline and at week 4 post-initiation of therapy, to assess the effect of DLBS1033 on systemic inflammatory status in Type 2 Diabetes Mellitus patients.

  Baseline and week 4

• VEGF (Vascular Endothelial Growth Factor)

  Serum VEGF levels measured using Enzyme-Linked Immunosorbent Assay (ELISA) at baseline and at week 4 post-initiation of therapy, to assess the effect of DLBS1033 on angiogenic factor regulation in Type 2 Diabetes Mellitus patients.

  Baseline and week 4

Secondary Outcomes (1)

• Quality of Life - EQ-5D-5L

  Baseline and week 4

Study Arms (3)

Group A (Low Dose)

EXPERIMENTAL

Patients with Type 2 Diabetes Mellitus who received oral Lumbricus Rubellus extract DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 3×1 tablet daily) combined with standard DM therapy during the 4-week observation period.

Drug: Oral Lumbricus Rubellus DLBS1033 (Low Dose); Other: Standard Diabetes Mellitus Therapy

Group B (High Dose)

EXPERIMENTAL

Patients with Type 2 Diabetes Mellitus who received oral Lumbricus Rubellus extract DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 3×2 tablets daily) combined with standard DM therapy during the 4-week observation period.

Drug: Oral Lumbricus Rubellus DLBS1033 (High Dose); Other: Standard Diabetes Mellitus Therapy

Control Group

PLACEBO COMPARATOR

Patients with Type 2 Diabetes Mellitus who received standard DM therapy alone during the 4-week observation period.

Other: Standard Diabetes Mellitus Therapy

Interventions

Oral Lumbricus Rubellus DLBS1033 (Low Dose) DRUG

DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 3×1 tablet t.i.d. for 4 weeks

Group A (Low Dose)

Oral Lumbricus Rubellus DLBS1033 (High Dose) DRUG

DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 3×2 tablets t.i.d. for 4 weeks

Group B (High Dose)

Standard Diabetes Mellitus Therapy OTHER

Standard Diabetes Mellitus Therapy

Control Group; Group A (Low Dose); Group B (High Dose)

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• Patients with diabetic foot ulcer grade 1-2.
• Patients with Diabetic Kidney Disease (DKD) Stage 5.
• Patients with chronic liver disease.
• Post-operative patients.
• Patients with malignancy.
• Patients with autoimmune disease or active infection.
• Non-compliant or uncooperative patients during the monitoring period.

Sponsors & Collaborators

• Universitas Sebelas Maret: lead

Study Sites (1)

Dr. Moewardi Regional General Hospital

Surakarta, Central Java, 57126, Indonesia

Location

Related Publications (3)

• 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

  BACKGROUND

MeSH Terms

Conditions

Diabetes Mellitus, Type 2

Condition Hierarchy (Ancestors)

Diabetes Mellitus; Glucose Metabolism Disorders; Metabolic Diseases; Nutritional and Metabolic Diseases; Endocrine System Diseases

Study Officials

• Nabila Aushaf Prasetyo, MD

  Department of Internal Medicine, Faculty of Medicine, Universitas Sebelas Maret Surakarta

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 4
• Allocation: RANDOMIZED
• Masking: NONE
• Masking Details: The study employs a block randomization method with a fixed block size of 4 to achieve balanced group assignments. Random allocation sequences will be generated independently using web-based software (www.random.org) and secured to maintain allocation concealment. Each treatment assignment will correspond to the generated random sequence distributed to eligible participants at enrollment.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Medical Doctor (Internist's Resident)

Model Details: This randomized, open-label, controlled trial employs a parallel-group experimental design to compare the adjunctive therapeutic effects of oral Lumbricus Rubellus extract DLBS1033 (490 mg t.i.d., in two dose groups) versus standard therapy alone in patients with Type 2 Diabetes Mellitus over a 4-week prospective observation period. The study will be conducted at the Endocrinology Outpatient Clinic of RSUD Dr. Moewardi Surakarta, Central Java, Indonesia, from May to June 2026, following ethical clearance from the Health Research Ethics Committee of the Faculty of Medicine, Universitas Sebelas Maret / RSUD Dr. Moewardi Surakarta.

Study Record Dates

• First Submitted: June 28, 2026
• First Posted: July 6, 2026
• Study Start: March 1, 2026
• Primary Completion: June 21, 2026
• Study Completion: June 28, 2026
• Last Updated: July 6, 2026

Record last verified: 2026-06

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, CSR
• Time Frame: June 28th, 2026-June 28th, 2027
• Access Criteria: Open access, every journal visitor

Locations

ID (1)