A Phase 2 interventional study of Placebo Tablet(s) and DLBS1033 in Pneumonia, Sepsis and Blood Coagulation Disorders, sponsored by Universitas Sebelas Maret. Completed at 1 site in Indonesia. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2026-10-23.
Sponsored by Universitas Sebelas Maret · Phase 2, Interventional, and Treatment
Pneumonia is a lung infection that can cause serious complications, especially when accompanied by sepsis. Sepsis can trigger excessive inflammation and abnormal blood clotting, potentially leading to organ damage and delayed recovery. Two blood markers, D-dimer and interleukin-6 (IL-6), may increase in patients with these conditions.
Lumbrokinase DLBS1033 (Disolf®) is an oral treatment derived from the earthworm Lumbricus rubellus. It has properties that may help break down fibrin, a protein involved in blood clot formation, and reduce inflammation.
This study aimed to determine whether adding Lumbrokinase DLBS1033 to standard hospital treatment could improve D-dimer and IL-6 levels, shorten the time needed to achieve clinical stability, and reduce the length of hospital stay in patients with pneumonia, sepsis, and hypercoagulability.
The study was conducted at Dr. Moewardi General Hospital in Surakarta, Indonesia. A total of 50 hospitalized patients were randomly assigned to two groups of 25 participants each. One group received standard treatment plus oral Lumbrokinase DLBS1033, while the other group received standard treatment plus a placebo containing no active study medicine. Neither the participants nor the blinded study investigators knew which treatment was assigned.
Blood samples were collected at three assessment points: baseline (H0), day 10 (H10), and a clinical stability-related assessment designated H+1. D-dimer and IL-6 levels were measured to assess changes in blood clotting activity and inflammation. Participants were also monitored for clinical stability using Halm's Criteria, length of hospital stay, and potential adverse events.
The study hypothesis was that Lumbrokinase DLBS1033, when added to standard treatment, would improve D-dimer and IL-6 levels and promote faster clinical recovery compared with standard treatment plus placebo.
Pneumonia complicated by sepsis is associated with systemic inflammation, endothelial dysfunction, and dysregulation of the coagulation system. These pathological processes may contribute to hypercoagulability, microvascular thrombosis, tissue hypoperfusion, and organ dysfunction. Elevated D-dimer levels reflect fibrin formation and degradation, while interleukin-6 (IL-6) is an important proinflammatory cytokine associated with the systemic inflammatory response.
Lumbrokinase DLBS1033 is a biologically derived preparation obtained from Lumbricus rubellus. Its fibrinolytic, fibrinogenolytic, antiplatelet, and potential anti-inflammatory properties provide a rationale for investigating its use as an adjunctive treatment in patients with pneumonia complicated by sepsis and hypercoagulability. This study was designed to evaluate whether adding DLBS1033 to standard medical treatment could improve coagulation-related and inflammatory biomarkers and accelerate clinical recovery.
The study employed a randomized, double-blind, placebo-controlled, parallel-group design with repeated biomarker measurements. Fifty hospitalized patients with pneumonia, sepsis, and hypercoagulability were enrolled and randomly allocated in a 1:1 ratio to the intervention or control group.
The intervention group received standard medical treatment for pneumonia and sepsis, including appropriate antimicrobial and supportive therapy, together with oral Lumbrokinase DLBS1033. The control group received the same standard medical treatment together with a matching placebo. The study treatment was administered according to the approved research protocol.
The study evaluated changes in D-dimer and IL-6 concentrations at three assessment points: H0, representing baseline before intervention; H10, representing the day-10 assessment; and H+1, representing the assessment associated with clinical stability according to Halm's Criteria. These serial measurements were used to assess biomarker changes over time and compare responses between the intervention and placebo groups.
Clinical condition was assessed daily using Halm's Clinical Stability Criteria, including relevant physiological and clinical indicators. Time to clinical stability was determined from the beginning of hospitalization until the participant fulfilled the predefined clinical stability criteria. Length of hospital stay was recorded from hospital admission until medically appropriate discharge.
Baseline clinical assessment included demographic characteristics, smoking history, body mass index, comorbidity assessment using the Charlson Comorbidity Index, pneumonia severity assessment using the Pneumonia Severity Index, and evaluation of sepsis-related organ dysfunction using SOFA and qSOFA scores.
Participant safety was monitored throughout treatment. Adverse events were documented using clinical observations, participant reports, and available medical records. Serious adverse events were subject to reporting procedures specified in the approved study protocol.
The study aimed to provide clinical evidence regarding the potential role of Lumbrokinase DLBS1033 as adjunctive therapy for modulating coagulation abnormalities and inflammatory responses and improving clinical recovery in patients with pneumonia complicated by sepsis and hypercoagulability.
2,072 studies on the registry are indexed under Pneumonia; 286 are open to participants now.
This study's enrollment of 50 is below the median of 107 across 1,263 interventional studies indexed under Pneumonia.
Browse Pneumonia studies →Universitas Sebelas Maret is the lead sponsor of 28 studies on the registry; 3 are open to participants now.
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Exclusion Criteria:
Participants in the placebo comparator group received standard medical treatment for pneumonia complicated by sepsis and hypercoagulability, including appropriate antimicrobial and supportive therapies, together with matching oral placebo tablets. The placebo was administered as one tablet twice daily during hospitalization until clinical stability was achieved according to Halm's Criteria.
Drug: Placebo Tablet(s)
Participants in the experimental group received standard medical treatment for pneumonia complicated by sepsis and hypercoagulability, including appropriate antimicrobial and supportive therapies, together with oral Lumbrokinase DLBS1033 (Disolf® 490 mg). The study drug was administered as one tablet twice daily (total daily dose: 980 mg) during hospitalization until clinical stability was achieved according to Halm's Criteria.
Drug: DLBS1033
Matching placebo tablets containing no active Lumbrokinase DLBS1033 were administered orally as one tablet twice daily, together with standard medical treatment for pneumonia complicated by sepsis and hypercoagulability. The placebo was administered according to the same treatment schedule as the experimental intervention until clinical stability was achieved based on Halm's Criteria.
Lumbrokinase DLBS1033 (Disolf®) is an oral preparation derived from Lumbricus rubellus with fibrinolytic and potential anti-inflammatory properties. Participants in the experimental group received DLBS1033 490 mg as one oral tablet twice daily (total daily dose: 980 mg), in addition to standard medical treatment for pneumonia complicated by sepsis and hypercoagulability. The intervention was administered during hospitalization until clinical stability was achieved according to Halm's Criteria.
Also known as: Lumbrokinase, Earthworm Extract, Lumbricus rubellus enzyme
Change From Baseline in D-Dimer Level
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.
Time frame: Baseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.
Change From Baseline in Interleukin-6 (IL-6) Level
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.
Time frame: Baseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.
Time to Clinical Stability Based on Halm's Criteria
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.
Time frame: From hospital admission until first achievement of clinical stability according to Halm's Criteria, assessed daily for up to 9 days.
Length of Hospital Stay
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.
Time frame: From hospital admission until discharge, assessed for up to 17 days.
Plan to share: No — Individual participant data (IPD) will not be made available to external researchers under the current data-sharing plan. Participant-level clinical and laboratory data are confidential and subject to participant privacy protections, institutional policies, and the research collaboration agreement between Universitas Sebelas Maret and PT Dexa Medica. Any future data-sharing arrangement would require prior written authorization from the relevant parties, appropriate ethical approval or review where applicable, and adequate safeguards for participant confidentiality. The data-sharing statement will be updated if a formal data-sharing plan is established.
Ran from Aug 2025 to primary completion in Sep 2025, 1 month.
Of 57 non-industry phase 2 interventional studies under Pneumonia, half reached primary completion within 11 months of starting (the median), counting those still running; a quarter within 6 and three quarters within 20. This study's 1 month is below that.
Counting every sponsor, half of 94 studies reached it within 11 months; a quarter within 6 and three quarters within 25.
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From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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Studies of the drug tested here: DLBS 1033
Universitas Sebelas Maret