Ischemic Stroke, AcutePhase 4NCT07121569
Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: Impact on Inflammatory Biomarkers and Outcomes
A Phase 4 study testing Oral lumbrokinase DLBS1033 in people with Ischemic Stroke, Acute, run by Universitas Sebelas Maret at 1 site in Indonesia.
Trial summary
This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of oral DLBS1033 as adjunctive therapy on inflammatory biomarkers (IL-6, TNF-α, MMP-9, D-dimer), transcranial Doppler (TCD) parameters, and clinical outcomes in patients with acute ischemic stroke. Read more about this study
- Who is it for?
- Ages 19 years and older
- Conditions the study is for
- Ischemic Stroke, Acute
- What is being tested?
- Oral lumbrokinase DLBS1033
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 52 participants
- Where
- 1 siteIndonesia
- Study dates
- 6 Jul 2024to 13 Mar 2025
- Phase
- Phase 4
- 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 19 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Inpatient with acute ischemic stroke onset 24 hours-7 days confirmed by CT scan.
- First-ever or recurrent ischemic stroke.
- Compos mentis on admission.
- NIHSS score 5-25 on admission.
- Willing to participate and signed informed consent
Who cannot join
- Hemorrhagic stroke within the last 3 months.
- Transient ischemic attack.
- Pregnant, breastfeeding, or planning pregnancy.
- Use of anticoagulants in the past month.
- Nasogastric tube feeding.
- Having or History of bleeding disorders or coagulopathy.
Show all 10Show fewer
- History of autoimmune disease.
- Severe renal impairment (serum creatinine ≥3× normal or on hemodialysis).
- Acute infection (systemic inflammatory response syndrome).
- Hypersensitivity to DLBS1033
Trial locations and contacts
1 site in 1 country.
Indonesia1 site
Dr. Moewardi Regional General Hospital
Surakarta, Central Java, 57126
About this study
Official title: Efficacy of Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: A Randomized Controlled Trial Evaluating Inflammatory Biomarkers, TCD Results, and Clinical Outcomes
This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of oral DLBS1033 as adjunctive therapy on inflammatory biomarkers (IL-6, TNF-α, MMP-9, D-dimer), transcranial Doppler (TCD) parameters, and clinical outcomes in patients with acute ischemic stroke. Fifty-two eligible patients admitted to RSUD Dr. Moewardi Surakarta will be randomly assigned to receive either DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) or placebo for 28 days, in addition to standard therapy between July 2024 to March 2025. The study was conducted in the inpatient ward, with follow-up at the outpatient clinic of the Neurology Department, Dr. Moewardi General Hospital, Surakarta, Central Java, following full ethical approval from the hospital's Health Research Ethics Committee. Primary outcomes include changes in inflammatory markers; secondary outcomes include changes in NIHSS and Barthel Index scores and TCD profiles.
Read the detailed description
Intravenous thrombolysis with tissue plasminogen activator (tPA) or mechanical thrombectomy is considered first-line treatment to mediate reperfusion. Despite the rapid restoration of cerebral blood flow post-stroke, recanalization of occluded vessels can lead to progressive tissue damage, a condition known as ischemia-reperfusion injury. Reperfusion triggers a strong inflammatory response, supporting the development of a thrombo-inflammatory cascade. Previous studies have shown that lumbrokinase, a component of DLBS1033, plays a role in modulating the inflammatory cascade. Lumbrokinase has been shown to significantly reduce several inflammatory biomarkers, such as IL-6, TNF-alpha, and MMP-9, in an animal study level. However, no studies have yet examined the role of lumbrokinase in reducing TNF-α, MMP-9, and IL-6 levels in the blood of patients with ischemic stroke. Previous studies stated that administration of DLBS1033 significantly improves clinical outcomes in ischemic stroke patients, as measured by NIHSS and Barthel Index scores. Based on this background, the researcher is interested in investigating the effect of oral DLBS1033 as adjunctive therapy on the thrombo-inflammatory patho-mechanism in patients with ischemic stroke, as assessed by inflammatory biomarkers, TCD parameters, and clinical outcomes.
Eligible patients diagnosed with acute ischemic stroke, presenting within a time window of 24 hours to 7 days from symptom onset, will be enrolled and randomly assigned into two parallel groups in a 1:1 ratio. The diagnosis of ischemic stroke was made based on physical examination and confirmed by a non-contrast head CT scan performed by a neurologist. One group will receive oral DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.), while the other will receive a matching placebo. Both interventions will be administered alongside standard stroke treatment protocols for a duration of 28 days. Randomization will be stratified to ensure balanced baseline characteristics between groups. Random allocation sequences were prepared by independent team and secured in sealed envelope. Each treatment package was pre-labeled with a unique subject identification number that corresponded to the assigned number in the randomization sequence. Upon enrollment, eligible participants received the treatment package that matched their assigned number.
Throughout the study, several key parameters will be assessed to evaluate the efficacy and safety of DLBS1033 as an adjunctive therapy. These include inflammatory biomarkers, such as serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), matrix metalloproteinase-9 (MMP-9), and D-dimer, which will be measured using validated immunoassay methods. In addition, cerebral hemodynamic status will be evaluated through Transcranial Doppler (TCD) ultrasonography to assess Pulsatility Index (PI), and carotid intima-media thickness (CIMT) will be measured via B-mode ultrasonography to examine vascular structural changes.
To evaluate clinical outcomes, the National Institutes of Health Stroke Scale (NIHSS) will be used to assess neurological deficits, and the Barthel Index will be used to evaluate functional independence in daily activities. All assessments, including laboratory biomarker tests, TCD and CIMT measurements, and clinical outcome scoring, will be conducted at three key time points: baseline, day 14, and day 28 post-initiation of therapy.
- Conditions
- Ischemic Stroke, Acute
- Being tested
- Oral lumbrokinase DLBS1033, Placebo
- Keywords
- Interleukin-6, Ischemic Stroke, Treatment outcome, Tumor Necrosis Factor-alpha, Oral lumbrokinase DLBS1033
- Medical subject headings
- Ischemic Stroke
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Oral lumbrokinase DLBS1033Drug
Also called DISOLF
DLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d
PlaceboDrug
Placebo by Dexa Medica, 2 tabs t.i.d.
| Study group | Role | What they receive |
|---|---|---|
| Oral lumbrokinase DLBS1033 group | Experimental | Patients with acute ischemic stroke who received oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d.) and 100 mg acetylsalicylic acid as standard stroke therapy during 28-days observation period Receives: Drug: Oral lumbrokinase DLBS1033 |
| Placebo group | Active comparator | Patients with acute ischemic stroke who received placebo (Placebo by Dexa Medica, 2 tabs t.i.d.) and 100 mg acetylsalicylic acid as standard stroke therapy during 28-days observation period Receives: Drug: Placebo |
What is being measured
The primary outcome is the main question the study is designed to answer.
MMP-9
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Measured: Baseline, day 14 and 28
IL-6
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Measured: Baseline, day 14 and 28
TNF-alpha
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Measured: Baseline, day 14 and 28
d-dimer
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
Measured: Baseline, day 14 and 28
Secondary outcomes (4)
TCD parameter-CIMT
Measurement of carotid intima-media thickness using TCD examination of the CCA was performed on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28. CIMT values fall within a positive range, greater than 0, where higher values indicate a possible thickening of the blood vessels, as a sign of atherosclerosis
Measured: Baseline, day 14 and 28
TCD parameter-PI
Measurement of the pulsatility index using TCD examination of the CCA, ICA, vertebral artery, MCA, ACA, PCA, and ROA was conducted on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28. PI values fall within a positive range, greater than 0, where higher values indicate greater vascular resistance.
Measured: Baseline, day 14 and 28
NIHSS
Assessment of stroke severity was conducted by evaluating various neurological functions, including consciousness, gaze, visual field, facial palsy, extrimity function, ataxia, sensory, language, dysarthria, and aphasia. This assessment was performed before the patient received therapy and after the patient had undergone therapy for 14 and 28 days. Minimum score is 0 and maximum score is 42, where a higher NIHSS score indicates a more severe degree of stroke.
Measured: Baseline, day 14 and 28
Barthel Index
Assessment of the ability to perform activities of daily living, such as eating, drinking, self-care, mobility, using the toilet, moving around, climbing stairs, dressing, and bladder and bowel control, was conducted before the patient received therapy and after the patient had undergone therapy for 14 and 28 days. Minimum score is 0 and maximum score is 100, where a higher Barthel Index score indicates better patient ADL function.
Measured: Baseline, day 14 and 28
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted13 Aug 2025
- Study start6 Jul 2024
- Primary completion4 Mar 2025
- Study completion13 Mar 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (2)Papers the sponsor has linked to this study.
- Other trials for Ischemic Stroke, AcuteStudies 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 4
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- This randomized, double-masked controlled trial employed a rigorous experimental design to compare the adjunctive therapeutic effects of oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) versus placebo in patients with acute ischemic stroke over a 28-day prospective observation period. The study was conducted in the inpatient ward, with follow-up at the outpatient clinic of the Neurology Department, Dr. Moewardi General Hospital, Surakarta, Central Java, Indonesia, from July 2024 to March 2025, after obtaining full ethical clearance from the hospital's Health Research Ethics Committee
- Masking
- Double blind
- Who is masked
- Participant, Investigator
- Enrolment
- 52 participants (actual)
Sponsor and investigators
- Lead sponsor
- Universitas Sebelas Maret
- Sponsor type
- University, hospital or other
- Responsible party
- Principal investigator, Firstiafina Tiffany, Universitas Sebelas Maret
- Investigators
- Firstiafina Tiffany, MD, Principal investigator, Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07121569
- Sponsor's protocol ID
- DLBS1033 on Ischemic Stroke
- Other IDs
- UST-003.24/DLBS1033/1/2024
- Status last verified
- Jun 2025
- First submitted
- 6 Aug 2025
- Last updated
- 14 Oct 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- Yes: Publication in ICMJE journals
Publications
Pinzon 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 33927846Wang WL, Hsu YM, Lin ML, Chen SS, Lai YH, Huang CH, Yao CH. Ex Vivo Model to Evaluate the Antibacterial and Anti-Inflammatory Effects of Gelatin-Tricalcium Phosphate Composite Incorporated with Emodin and Lumbrokinase for Bone Regeneration. Bioengineering (Basel). 2023 Jul 31;10(8):906. doi: 10.3390/bioengineering10080906.
PubMed 37627791
Study at a glance
From the registry record, last updated by the sponsor on 14 Oct 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Efficacy of Oral DLBS1033 as Adjunctive Therapy in Acute Ischemic Stroke: A Randomized Controlled Trial Evaluating Inflammatory Biomarkers, TCD Results, and Clinical Outcomes
- ClinicalTrials.gov ID
- NCT07121569
- Acronym / sponsor ID
- DLBS1033 on Ischemic Stroke
- Conditions
- Ischemic Stroke, Acute
- Keywords
- Interleukin-6, Ischemic Stroke, Treatment outcome, Tumor Necrosis Factor-alpha, Oral lumbrokinase DLBS1033
- Phase
- Phase 4
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 52 participants (actual)
- Lead sponsor
- Universitas Sebelas MaretUniversity, hospital or other
- Study start
- 6 Jul 2024 (actual)
- Primary completion
- 4 Mar 2025 (actual)
- Study completion
- 13 Mar 2025 (actual)
- First posted
- 13 Aug 2025 (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.
This randomized, double-blind, placebo-controlled trial aims to evaluate the effect of oral DLBS1033 as adjunctive therapy on inflammatory biomarkers (IL-6, TNF-α, MMP-9, D-dimer), transcranial Doppler (TCD) parameters, and clinical outcomes in patients with acute ischemic stroke. Fifty-two eligible patients admitted to RSUD Dr. Moewardi Surakarta will be randomly assigned to receive either DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) or placebo for 28 days, in addition to standard therapy between July 2024 to March 2025. The study was conducted in the inpatient ward, with follow-up at the outpatient clinic of the Neurology Department, Dr. Moewardi General Hospital, Surakarta, Central Java, following full ethical approval from the hospital's Health Research Ethics Committee. Primary outcomes include changes in inflammatory markers; secondary outcomes include changes in NIHSS and Barthel Index scores and TCD profiles.
Detailed description
Intravenous thrombolysis with tissue plasminogen activator (tPA) or mechanical thrombectomy is considered first-line treatment to mediate reperfusion. Despite the rapid restoration of cerebral blood flow post-stroke, recanalization of occluded vessels can lead to progressive tissue damage, a condition known as ischemia-reperfusion injury. Reperfusion triggers a strong inflammatory response, supporting the development of a thrombo-inflammatory cascade. Previous studies have shown that lumbrokinase, a component of DLBS1033, plays a role in modulating the inflammatory cascade. Lumbrokinase has been shown to significantly reduce several inflammatory biomarkers, such as IL-6, TNF-alpha, and MMP-9, in an animal study level. However, no studies have yet examined the role of lumbrokinase in reducing TNF-α, MMP-9, and IL-6 levels in the blood of patients with ischemic stroke. Previous studies stated that administration of DLBS1033 significantly improves clinical outcomes in ischemic stroke patients, as measured by NIHSS and Barthel Index scores. Based on this background, the researcher is interested in investigating the effect of oral DLBS1033 as adjunctive therapy on the thrombo-inflammatory patho-mechanism in patients with ischemic stroke, as assessed by inflammatory biomarkers, TCD parameters, and clinical outcomes.
Eligible patients diagnosed with acute ischemic stroke, presenting within a time window of 24 hours to 7 days from symptom onset, will be enrolled and randomly assigned into two parallel groups in a 1:1 ratio. The diagnosis of ischemic stroke was made based on physical examination and confirmed by a non-contrast head CT scan performed by a neurologist. One group will receive oral DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.), while the other will receive a matching placebo. Both interventions will be administered alongside standard stroke treatment protocols for a duration of 28 days. Randomization will be stratified to ensure balanced baseline characteristics between groups. Random allocation sequences were prepared by independent team and secured in sealed envelope. Each treatment package was pre-labeled with a unique subject identification number that corresponded to the assigned number in the randomization sequence. Upon enrollment, eligible participants received the treatment package that matched their assigned number.
Throughout the study, several key parameters will be assessed to evaluate the efficacy and safety of DLBS1033 as an adjunctive therapy. These include inflammatory biomarkers, such as serum levels of interleukin-6 (IL-6), tumor necrosis factor-alpha (TNF-α), matrix metalloproteinase-9 (MMP-9), and D-dimer, which will be measured using validated immunoassay methods. In addition, cerebral hemodynamic status will be evaluated through Transcranial Doppler (TCD) ultrasonography to assess Pulsatility Index (PI), and carotid intima-media thickness (CIMT) will be measured via B-mode ultrasonography to examine vascular structural changes.
To evaluate clinical outcomes, the National Institutes of Health Stroke Scale (NIHSS) will be used to assess neurological deficits, and the Barthel Index will be used to evaluate functional independence in daily activities. All assessments, including laboratory biomarker tests, TCD and CIMT measurements, and clinical outcome scoring, will be conducted at three key time points: baseline, day 14, and day 28 post-initiation of therapy.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Double blind (participant, investigator)
- Number of arms
- 2
- Model description
- This randomized, double-masked controlled trial employed a rigorous experimental design to compare the adjunctive therapeutic effects of oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tab t.i.d.) versus placebo in patients with acute ischemic stroke over a 28-day prospective observation period. The study was conducted in the inpatient ward, with follow-up at the outpatient clinic of the Neurology Department, Dr. Moewardi General Hospital, Surakarta, Central Java, Indonesia, from July 2024 to March 2025, after obtaining full ethical clearance from the hospital's Health Research Ethics Committee
| Arm | Type | Receives |
|---|---|---|
| Oral lumbrokinase DLBS1033 group | Experimental | Drug: Oral lumbrokinase DLBS1033Patients with acute ischemic stroke who received oral lumbrokinase DLBS1033 (490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d.) and 100 mg acetylsalicylic acid as standard stroke therapy during 28-days observation period |
| Placebo group | Active comparator | Drug: PlaceboPatients with acute ischemic stroke who received placebo (Placebo by Dexa Medica, 2 tabs t.i.d.) and 100 mg acetylsalicylic acid as standard stroke therapy during 28-days observation period |
Who may qualify
- Ages
- 19 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (5 listed)
- Inpatient with acute ischemic stroke onset 24 hours-7 days confirmed by CT scan.
- First-ever or recurrent ischemic stroke.
- Compos mentis on admission.
- NIHSS score 5-25 on admission.
- Willing to participate and signed informed consent
Key exclusion criteria (10 listed)
- Hemorrhagic stroke within the last 3 months.
- Transient ischemic attack.
- Pregnant, breastfeeding, or planning pregnancy.
- Use of anticoagulants in the past month.
- Nasogastric tube feeding.
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 |
|---|---|---|
| Oral lumbrokinase DLBS1033Also: DISOLFDLBS1033: 490 mg, DISOLF film-coated tablet, Dexa Medica, 2 tabs t.i.d | Drug | Oral lumbrokinase DLBS1033 group |
| PlaceboPlacebo by Dexa Medica, 2 tabs t.i.d. | Drug | Placebo group |
Primary outcome
MMP-9
Time frame: Baseline, day 14 and 28
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
IL-6
Time frame: Baseline, day 14 and 28
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
TNF-alpha
Time frame: Baseline, day 14 and 28
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
d-dimer
Time frame: Baseline, day 14 and 28
The inflammatory biomarkers were measured on the day of admission for stroke onset of 4-7 days, or on the third day for stroke onset of 1-3 days, and after the patient had received therapy on days 14 and 28
4 secondary outcomes
TCD parameter-CIMT
Time frame: Baseline, day 14 and 28
TCD parameter-PI
Time frame: Baseline, day 14 and 28
NIHSS
Time frame: Baseline, day 14 and 28
Barthel Index
Time frame: Baseline, day 14 and 28
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 14 Oct 2026.
- 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 37627791Wang WL, Hsu YM, Lin ML, Chen SS, Lai YH, Huang CH, Yao CH. Ex Vivo Model to Evaluate the Antibacterial and Anti-Inflammatory Effects of Gelatin-Tricalcium Phosphate Composite Incorporated with Emodin and Lumbrokinase for Bone Regeneration. Bioengineering (Basel). 2023 Jul 31;10(8):906. doi: 10.3390/bioengineering10080906.
- Related InfoLink provided by the sponsor.
- Individual participant dataSharing planned: Yes. Publication in ICMJE journals
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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.
Firstiafina Tiffany, MD principal investigator
Department of Neurology, Faculty of Medicine, Universitas Sebelas Maret
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 4 study testing Oral lumbrokinase DLBS1033 in people with Ischemic Stroke, Acute, 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 5 inclusion and 10 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 14 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. 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 4 studies take place after a treatment is approved, to learn more about its long-term benefits and risks in everyday use.
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?
MMP-9 (time frame: Baseline, day 14 and 28). The study lists 4 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 NCT07121569, which also lists 2 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 14 Oct 2026.