PneumoniaPhase 2NCT07892794
Effects of Lumbrokinase DLBS1033 on D-Dimer, Interleukin-6, and Clinical Outcomes in Patients With Pneumonia and Sepsis
A Phase 2 study testing DLBS1033 in people with Pneumonia and Sepsis, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- Pneumonia, Sepsis, Blood Coagulation Disorders
- What is being tested?
- DLBS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 50 participants
- Where
- 1 siteIndonesia
- Study dates
- 14 Aug 2025to 30 Sep 2025
- Phase
- Phase 2
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Adult patients aged 18 years or older.
- Patients diagnosed with community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) complicated by sepsis.
- Patients meeting sepsis assessment criteria based on the Sequential Organ Failure Assessment (SOFA) or quick Sequential Organ Failure Assessment (qSOFA).
- Patients with elevated D-dimer levels of at least twice the upper limit of normal (≥1,000 ng/mL FEU), indicating a hypercoagulable state.
- Patients who had not yet received specific treatment targeting severe pneumonia and sepsis at the time of recruitment.
- Patients with a Charlson Comorbidity Index (CCI) score below 4.
- Patients who voluntarily agreed to participate and provided written informed consent.
Who cannot join
- Patients requiring a nasogastric tube (NGT), because the oral Lumbrokinase DLBS1033 formulation cannot be crushed or administered through an NGT.
- Pregnant or breastfeeding women.
- Patients with a history of severe allergic reactions to earthworm extracts or any component of Lumbrokinase DLBS1033.
- Patients with other active infections or serious medical conditions that could interfere with the clinical evaluation of pneumonia and sepsis.
- Patients with unstable comorbid conditions, including diabetes mellitus with acute hyperglycemia or an active myocardial infarction.
- Patients with a Charlson Comorbidity Index (CCI) score of 4 or higher.
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi General Hospital, Faculty of Medicine, Universitas Sebelas Maret (UNS)
Surakarta, Central Java, 57126
About this study
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
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.
Read more
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.
Read the detailed description
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.
- Conditions
- Pneumonia, Sepsis, Blood Coagulation Disorders
- Being tested
- Placebo Tablet(s), DLBS1033
- Keywords
- Lumbrokinase DLBS1033, D-dimer, Interleukin-6 (IL-6), Time to Clinical Stability, Length of Stay, Randomized Controlled Trial, Hypercoagulability, Halm's Criteria
- Medical subject headings
- Pneumonia, Sepsis, Blood Coagulation Disorders, Thrombophilia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo Tablet(s)Drug
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.
DLBS1033Drug
Also called Lumbrokinase, Earthworm Extract, Lumbricus rubellus enzyme
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.
| Study group | Role | What they receive |
|---|---|---|
| Standard Therapy + Placebo | Placebo comparator | 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. Receives: Drug: Placebo Tablet(s) |
| Standard Therapy + Lumbrokinase DLBS1033 | Experimental | 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. Receives: Drug: DLBS1033 |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: 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.
Measured: Baseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.
Secondary outcomes (2)
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.
Measured: 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.
Measured: From hospital admission until discharge, assessed for up to 17 days.
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted23 Oct 2026
- Study start14 Aug 2025
- Primary completion23 Sep 2025
- Study completion30 Sep 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (5)Papers the sponsor has linked to this study.
- Other trials for PneumoniaStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase 2
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This study employed a randomized, double-blind, placebo-controlled, two-arm parallel-group design. A total of 50 participants were randomly assigned in a 1:1 ratio to receive either standard therapy plus oral Lumbrokinase DLBS1033 (n=25) or standard therapy plus placebo (n=25). Participants remained in their assigned treatment groups throughout the study. D-dimer and interleukin-6 levels were assessed at baseline (H0), day 10 (H10), and a clinical stability-related assessment (H+1). Time to clinical stability and length of hospital stay were also evaluated.
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 50 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Eldaa Putik Bunga Melati, Universitas Sebelas Maret
- Investigators
- Eldaa Putik Bunga Melati, MD, Principal investigator, Faculty of Medicine of Universitas Sebelas Maret (UNS)
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07892794
- Sponsor's protocol ID
- UST-002.25/DLBS1033/1/2025
- Other IDs
- 68.2/UN27/KS/2025
- Status last verified
- Oct 2026
- First submitted
- 12 Oct 2026
- Last updated
- 23 Oct 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- 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.
Publications
Bastrup Israelsen S, Fally M, Brok Nielsen P, Kolte L, Karmark Iversen K, Ravn P, Benfield T. Reassessing Halm's clinical stability criteria in community-acquired pneumonia management. Eur Respir J. 2024 Nov 7;64(5):2400054. doi: 10.1183/13993003.00054-2024. Print 2024 Nov.
PubMed 39174283Gayatri A, Nafrialdi N, Setiabudy RD, Tjandrawinata RR, Rachman A, Louisa M. A Clinical Trial on Biological Half Life of Bioactive Protein from Lumbricus rubellus, DLBS1033 in Healthy Volunteers. Acta Med Indones. 2018 Jul;50(3):208-214.
PubMed 30333270Pinzon RT, Tjandrawinata RR, Wijaya VO, Veronica V. Effect of DLBS1033 on Functional Outcomes for Patients with Acute Ischemic Stroke: A Randomized Controlled Trial. Stroke Res Treat. 2021 Apr 7;2021:5541616. doi: 10.1155/2021/5541616. eCollection 2021.
PubMed 33927846Tjandrawinata RR, Trisina J, Rahayu P, Prasetya LA, Hanafiah A, Rachmawati H. Bioactive protein fraction DLBS1033 containing lumbrokinase isolated from Lumbricus rubellus: ex vivo, in vivo, and pharmaceutic studies. Drug Des Devel Ther. 2014 Sep 25;8:1585-93. doi: 10.2147/DDDT.S66007. eCollection 2014.
PubMed 25284988Trisina J, Sunardi F, Suhartono MT, Tjandrawinata RR. DLBS1033, a protein extract from Lumbricus rubellus, possesses antithrombotic and thrombolytic activities. J Biomed Biotechnol. 2011;2011:519652. doi: 10.1155/2011/519652. Epub 2011 Mar 3.
PubMed 21403877
Study at a glance
From the registry record, last updated by the sponsor on 23 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- 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
- ClinicalTrials.gov ID
- NCT07892794
- Acronym / sponsor ID
- UST-002.25/DLBS1033/1/2025
- Conditions
- Pneumonia, Sepsis, Blood Coagulation Disorders
- Keywords
- Lumbrokinase DLBS1033, D-dimer, Interleukin-6 (IL-6), Time to Clinical Stability, Length of Stay, Randomized Controlled Trial, Hypercoagulability, Halm's Criteria
- Phase
- Phase 2
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 50 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 14 Aug 2025 (actual)
- Primary completion
- 23 Sep 2025 (actual)
- Study completion
- 30 Sep 2025 (actual)
- First posted
- 23 Oct 2026 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Detailed description
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.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This study employed a randomized, double-blind, placebo-controlled, two-arm parallel-group design. A total of 50 participants were randomly assigned in a 1:1 ratio to receive either standard therapy plus oral Lumbrokinase DLBS1033 (n=25) or standard therapy plus placebo (n=25). Participants remained in their assigned treatment groups throughout the study. D-dimer and interleukin-6 levels were assessed at baseline (H0), day 10 (H10), and a clinical stability-related assessment (H+1). Time to clinical stability and length of hospital stay were also evaluated.
| Arm | Type | Receives |
|---|---|---|
| Standard Therapy + Placebo | Placebo comparator | Drug: Placebo Tablet(s)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. |
| Standard Therapy + Lumbrokinase DLBS1033 | Experimental | Drug: DLBS1033Participants 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (7 listed)
- Adult patients aged 18 years or older.
- Patients diagnosed with community-acquired pneumonia (CAP) or hospital-acquired pneumonia (HAP) complicated by sepsis.
- Patients meeting sepsis assessment criteria based on the Sequential Organ Failure Assessment (SOFA) or quick Sequential Organ Failure Assessment (qSOFA).
- Patients with elevated D-dimer levels of at least twice the upper limit of normal (≥1,000 ng/mL FEU), indicating a hypercoagulable state.
- Patients who had not yet received specific treatment targeting severe pneumonia and sepsis at the time of recruitment.
Key exclusion criteria (6 listed)
- Patients requiring a nasogastric tube (NGT), because the oral Lumbrokinase DLBS1033 formulation cannot be crushed or administered through an NGT.
- Pregnant or breastfeeding women.
- Patients with a history of severe allergic reactions to earthworm extracts or any component of Lumbrokinase DLBS1033.
- Patients with other active infections or serious medical conditions that could interfere with the clinical evaluation of pneumonia and sepsis.
- Patients with unstable comorbid conditions, including diabetes mellitus with acute hyperglycemia or an active myocardial infarction.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 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. | Drug | Standard Therapy + Placebo |
| DLBS1033Also: Lumbrokinase, Earthworm Extract, Lumbricus rubellus enzymeLumbrokinase 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. | Drug | Standard Therapy + Lumbrokinase DLBS1033 |
Primary outcome
Change From Baseline in D-Dimer Level
Time frame: Baseline (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.
Change From Baseline in Interleukin-6 (IL-6) Level
Time frame: Baseline (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.
2 secondary outcomes
Time to Clinical Stability Based on Halm's Criteria
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
Time frame: From hospital admission until discharge, assessed for up to 17 days.
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 23 Oct 2026.
- Background: PubMed 39174283Bastrup Israelsen S, Fally M, Brok Nielsen P, Kolte L, Karmark Iversen K, Ravn P, Benfield T. Reassessing Halm's clinical stability criteria in community-acquired pneumonia management. Eur Respir J. 2024 Nov 7;64(5):2400054. doi: 10.1183/13993003.00054-2024. Print 2024 Nov.
- Background: PubMed 30333270Gayatri A, Nafrialdi N, Setiabudy RD, Tjandrawinata RR, Rachman A, Louisa M. A Clinical Trial on Biological Half Life of Bioactive Protein from Lumbricus rubellus, DLBS1033 in Healthy Volunteers. Acta Med Indones. 2018 Jul;50(3):208-214.
- Background: PubMed 33927846Pinzon RT, Tjandrawinata RR, Wijaya VO, Veronica V. Effect of DLBS1033 on Functional Outcomes for Patients with Acute Ischemic Stroke: A Randomized Controlled Trial. Stroke Res Treat. 2021 Apr 7;2021:5541616. doi: 10.1155/2021/5541616. eCollection 2021.
- Background: PubMed 25284988Tjandrawinata RR, Trisina J, Rahayu P, Prasetya LA, Hanafiah A, Rachmawati H. Bioactive protein fraction DLBS1033 containing lumbrokinase isolated from Lumbricus rubellus: ex vivo, in vivo, and pharmaceutic studies. Drug Des Devel Ther. 2014 Sep 25;8:1585-93. doi: 10.2147/DDDT.S66007. eCollection 2014.
- Background: PubMed 21403877Trisina J, Sunardi F, Suhartono MT, Tjandrawinata RR. DLBS1033, a protein extract from Lumbricus rubellus, possesses antithrombotic and thrombolytic activities. J Biomed Biotechnol. 2011;2011:519652. doi: 10.1155/2011/519652. Epub 2011 Mar 3.
- Individual participant dataSharing planned: 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.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Eldaa Putik Bunga Melati, MD principal investigator
Faculty of Medicine of Universitas Sebelas Maret (UNS)
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2 study testing DLBS1033 in people with Pneumonia and Sepsis, run by Universitas Sebelas Maret at 1 site in Indonesia.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 7 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 23 Oct 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Indonesia. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. Some participants in this study may receive a placebo. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
What does this phase mean?
Phase 2 studies give the treatment to a larger group to see whether it has the intended effect and to keep checking safety.
Not every study follows the same path, and some studies (observational studies, device studies) have no phase.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change From Baseline in D-Dimer Level (time frame: Baseline (Day 0), Day 10, and the clinical stability-related assessment (H+1) during hospitalization.). The study lists 2 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07892794, which also lists 5 linked publications.
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 23 Oct 2026.