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

NCT07684625 · Status: COMPLETED · Phase: PHASE4 · Type: INTERVENTIONAL · Enrollment: 60

Last updated 2026-07-06

No results posted yet for this study

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

Interventions

DRUG

Oral Lumbricus Rubellus DLBS1033 (Low Dose)

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

DRUG

Oral Lumbricus Rubellus DLBS1033 (High Dose)

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

OTHER

Standard Diabetes Mellitus Therapy

Standard Diabetes Mellitus Therapy

Sponsors & Collaborators

  • Universitas Sebelas Maret

    lead OTHER

Principal Investigators

  • Nabila Aushaf Prasetyo, MD · Department of Internal Medicine, Faculty of Medicine, Universitas Sebelas Maret Surakarta

Study Design

Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
NONE
Model
PARALLEL

Eligibility

Min Age
18 Years
Sex
ALL
Healthy Volunteers
No

Timeline & Regulatory

Start
2026-03-01
Primary Completion
2026-06-21
Completion
2026-06-28

Countries

  • Indonesia

Study Locations

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Read the full study record

This page highlights key information. For complete eligibility criteria, study locations, investigator contacts, and the full protocol, visit the original record on ClinicalTrials.gov.

View NCT07684625 on ClinicalTrials.gov