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Effects of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, and Clinical Outcomes in Patients With Pneumonia and Sepsis
Sponsor: Universitas Sebelas Maret
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.
Official title: Effect of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, Length of Stay, and Time to Clinical Stability in Patients With Pneumonia, Sepsis, and Hypercoagulability
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
50
Start Date
2025-08-14
Completion Date
2025-09-30
Last Updated
2026-10-23
Healthy Volunteers
No
Interventions
Placebo Tablet(s)
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.
DLBS1033
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.
Locations (1)
Dr. Moewardi General Hospital, Faculty of Medicine, Universitas Sebelas Maret (UNS)
Surakarta, Central Java, Indonesia