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Life sciences · Phase 2 Trial
ClinicalTrials.gov · October 23, 2026
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Phase 2 Trial.
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Registry record from ClinicalTrials.gov (NCT07892794). This is a study registration, not published results. Lead sponsor: Universitas Sebelas Maret. Recruitment status: COMPLETED. Phase: PHASE2. Study type: INTERVENTIONAL. Enrollment: 50 participants (ACTUAL). Conditions: Pneumonia, Sepsis, Blood Coagulation Disorders. Interventions: DRUG: Placebo Tablet(s); DRUG: DLBS1033. Primary outcome measures: Change From Baseline in D-Dimer Level , Baseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.; Change From Baseline in Interleukin-6 (IL-6) Level , Baseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.. Brief summary: 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.