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Trial · NCT07892794

Effects of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, and Clinical Outcomes in Patients With Pneumonia and Sepsis

NCT07892794, Phase 2, Completed, Universitas Sebelas Maret

3 sourcestrials-2026-11-12-0.5.0

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ConductScience Library. Effects of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, and Clinical Outcomes in Patients With Pneumonia and Sepsis. Trials, record NCT07892794. Release trials-2026-11-12-0.5.0, 12 Nov 2026. https://conductscience.org/library/trials/NCT07892794

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Trial

As registered on ClinicalTrials.gov, in the graph's capture of the registry.

Title
Effects of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, and Clinical Outcomes in Patients With Pneumonia and Sepsis
NCT number
NCT07892794
Status
Completed
Phases
Phase 2
Enrollment
50 participants, actual
Lead sponsor
Universitas Sebelas Maret
Conditions
Pneumonia, Sepsis, Blood Coagulation Disorders
Interventions
Placebo Tablet(s), DLBS1033
First posted
2026-10-23
Last updated
2026-10-23

Source ClinicalTrials.gov

Registered outcomes4

Each outcome the trial registered, primary first, in ClinicalTrials.gov's words.

ListOutcomeTime frameDescription
PrimaryChange From Baseline in D-Dimer LevelBaseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.
Changes in blood D-dimer concentration were evaluated to assess coagulation-related responses to Lumbrokinase DLBS1033. D-dimer levels were measured in ng/mL at baseline (H0), day 10 (H10), and the clinical stability-related assessment (H+1). Changes from baseline were calculated for each participant as the D-dimer concentration at H10 or H+1 minus the baseline concentration at H0. Negative values indicate a reduction in D-dimer levels. The magnitude of change was compared between the Lumbrokinase DLBS1033 and placebo groups.
PrimaryChange From Baseline in Interleukin-6 (IL-6) LevelBaseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.
Changes in blood interleukin-6 (IL-6) concentration were evaluated to assess the inflammatory response to Lumbrokinase DLBS1033. IL-6 levels were measured in pg/mL at baseline (H0), day 10 (H10), and the clinical stability-related assessment (H+1). Changes from baseline were calculated for each participant as the IL-6 concentration at H10 or H+1 minus the baseline concentration at H0. Negative values indicate a reduction in IL-6 levels. The magnitude of change was compared between the Lumbrokinase DLBS1033 and placebo groups.
SecondaryTime to Clinical Stability Based on Halm's CriteriaFrom hospital admission until first achievement of clinical stability according to Halm's Criteria, assessed daily for up to 9 days.
Time to clinical stability was defined as the duration, measured in hours, from hospital admission until the patient first achieved clinical stability according to Halm's Criteria. Clinical stability was assessed using physiological and clinical parameters, including body temperature, heart rate, respiratory rate, blood pressure, oxygen saturation, mental status, and ability to maintain oral intake. Participants were evaluated daily during hospitalization. Time to clinical stability was compared between the Lumbrokinase DLBS1033 and placebo groups.
SecondaryLength of Hospital StayFrom hospital admission until discharge, assessed for up to 17 days.
Length of hospital stay (LOS) was defined as the total duration of hospitalization, measured in hours, from hospital admission until medically authorized discharge. Admission and discharge times were obtained from hospital medical records. The duration of hospitalization was compared between the Lumbrokinase DLBS1033 and placebo groups to evaluate the effect of adjunctive treatment on clinical recovery and hospital stay.

Outcomes0

Each outcome the trial posted results for, in ClinicalTrials.gov's words.

None in this release.

Results by group0

Each measurement the trial posted, group by group, in the words and numbers it posted.

None in this release.

Participant flow0

How many started, completed or left each group, period by period.

None in this release.

Adverse events0

Each adverse event the trial posted, group by group: the participants affected out of those at risk.

None in this release.

Adverse event totals0

The totals the trial posted for each group.

None in this release.

Papers5

The papers the trial lists on ClinicalTrials.gov.

PMIDListed asSource
21403877BACKGROUNDPubMed
25284988BACKGROUNDPubMed
30333270BACKGROUNDPubMed
33927846BACKGROUNDPubMed
39174283BACKGROUNDPubMed

Grants0

The grants NIH RePORTER links to the trial, newest funded first: NIH's, and some of AHRQ's, CDC's, FDA's and VA's. Each shows its title, principal investigators, organization and funder in its newest year.

None in this release.

Trial comparisons0

Comparisons of the trial's two groups, calculated by ConductScience from the counts it posted.

None in this release.

Tests0

The ConductCognition tests this trial's registered outcomes name, as ScienceGraph matched them in trial-tests-2026-11-12-0.2.1.

None in this release.

Data dates

The day each source was copied for this release.

ClinicalTrials.gov
2026-11-12
ClinicalTrials.gov
Results, from AACT
2026-03-23
AACT
NIH grant links
2026-11-13
NIH RePORTER

Sources 3

  • ClinicalTrials.gov's posted results, through CTTI's AACTFreely available. Acknowledgement requested
  • ClinicalTrials.govNo license stated
  • NIH RePORTER's clinical studies and project filesPublic domain
Each source's terms
  • ClinicalTrials.gov's posted results, through CTTI's AACTClinicalTrials.gov data via Aggregate Analysis of ClinicalTrials.gov (AACT), CTTI. CTTI makes its materials freely available and requests acknowledgement. https://aact.ctti-clinicaltrials.org/documentation/299
  • ClinicalTrials.govnone stated
  • NIH RePORTER's clinical studies and project filesPublic domain (NIH RePORTER)

ClinicalTrials.gov's data carry an international copyright outside the United States: https://clinicaltrials.gov/about-site/terms-conditions.

For software

Read this trial from software.

The record and each of its lists are JSON, twenty rows a page. No key.

GET https://conductscience.org/api/trials/v1/NCT07892794

GET https://conductscience.org/api/trials/v1/NCT07892794/registered