Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.
RECRUITING
PHASE3
106 participants
INTERVENTIONAL
2022-12-09
2025-08-31
Brief Summary
Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.
The bioactive fraction of DLBS2411 has been proved at cellular and genetic levels to have an antiulcer effect through both suppressing the gastric acidity and enhancing gastric mucosal protection. The anti-secretory effect of DLBS2411 is exerted through the inhibition of H+/K+ ATPase 'pump' as well as down-regulation of the H+/K+ ATPase gene expression, thus suppressing gastric acid secretion; while its cytoprotective defense mechanism works through the promotion of cyclooxygenase-2 (COX-2) derived prostaglandin (PgE2) synthesis, thus promoting gastrointestinal submucosal blood-flow, stimulating secretion of gastric-epithelial mucous and bicarbonate; anti-oxidative activity; and endothelial-nitric oxide (NO) formation. The mechanism altogether demonstrated DLBS2411's protective capacity to the gastric and colon mucosa by promoting mucous synthesis and stimulating mucosal blood flow.
Having such mechanisms of action, DLBS2411 is hypothesized to benefit subjects with gastric acid disorders such as in functional dyspepsia, gastro-intestinal reflux disease (GERD), peptic-ulcer, and irritable bowel syndrome (IBS).
Related Clinical Trials
Explore similar clinical trials based on study characteristics and research focus.
Efficacy and Safety of DLBS2411 in the Management of GERD
NCT03367195
Clinical Trial of DA-5212 in Patients with Functional Dyspepsia
NCT05842408
Clinical Trial for the Evaluation of the Efficacy and Safety of EDL on Dyspepsia
NCT04482478
To Evaluate the Efficacy and Safety in Subjects With Functional Dyspepsia
NCT00323817
A Study to Check the Safety of Dexlansoprazole and Learn If it Can Heal Erosive Esophagitis (EE) and Keep it Healed in Children 2 to 11 Years Old
NCT02615184
Detailed Description
Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.
There will be 2 groups of treatment; Treatment 1: placebo DLBS2411 caplet Treatment 2: DLBS2411 250 mg caplet Each study medication will be administered 1 caplet twice daily, 30 minutes before meal, in the morning and evening.
Eligible subjects will be randomly allocated to receive either Treatment 1 or Treatment 2 for 4 weeks, in a double blind fashion. Subjects will be instructed to come to the clinic every 2-week interval throughout the 4-week study period (at Week 2, and 4, respectively) and 8 weeks after the end of therapy (Week 12), for efficacy evaluation. The safety evaluation will be performed at Baseline and End of therapy (Week 4). Adverse events will be monitored at baseline and every follow-up visit including End of study (Week 12).
Conditions
See the medical conditions and disease areas that this research is targeting or investigating.
Study Design
Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.
RANDOMIZED
PARALLEL
TREATMENT
QUADRUPLE
Study Groups
Review each arm or cohort in the study, along with the interventions and objectives associated with them.
Control
Placebo DLBS2411 2 x 1 caplet daily, given everyday for 4 weeks of study period
Placebo caplet of DLBS2411
1 caplet of placebo DLBS2411, twice daily
DLBS2411
DLBS2411 caplet 2 x 250 mg daily, given everyday for 4 weeks of study period
DLBS2411
1 caplet of DLBS2411 250 mg, twice daily
Interventions
Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.
Placebo caplet of DLBS2411
1 caplet of placebo DLBS2411, twice daily
DLBS2411
1 caplet of DLBS2411 250 mg, twice daily
Other Intervention Names
Discover alternative or legacy names that may be used to describe the listed interventions across different sources.
Eligibility Criteria
Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.
Inclusion Criteria
2. Male or female subjects aged of 18 - 75 years old.
3. Meet Rome IV criteria for FD, which includes:
1. One or more of the following symptoms:
* bothersome postprandial fullness
* early satiation, that prevents finishing a regular meal, at least several times per week.
* epigastric pain, epigastric burning. The symptoms are persistently present (i.e. occurring at least one day per month (for male) or 2-3 days per month (for female) for at least the past 3 months with symptom onset at least 6 months prior to study Screening.
2. Having no evidence of structural or organic gastrointestinal (GI) disease that is likely to explain the symptoms, as verified by a normal esophagogastroduodenoscopy (EGD) performed within the past 3 years.
4. Subjects who tested negative for Helicobacter pylori by urea breath-test, histological or rapid test during the screening period.
5. Able to take oral medication.
Exclusion Criteria
2. Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactive result) for SARS-COV-2.
3. GERD as confirmed by any documented history of endoscopic esophagitis, or clinical symptoms such as predominant heartburn or acid regurgitation, \>2x/week in the prior year.
4. History of or known or suspected Zollinger Ellison syndrome.
5. History of or known gastrointestinal malignancy or ulcers associated to malignancy.
6. Hepatic cirrhosis or abnormal liver laboratory findings (defined as \>3xULN of ALT or AST).
7. Being under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR \<60 mL/min).
8. History of or known congestive heart failure NYHA class III and IV, or any other uncontrolled chronic diseases, such as: uncontrolled hypertension (systolic/diastolic blood pressure ≥160/100 mmHg); uncontrolled diabetes (HbA1c c ≥7%).
9. Currently known being afflicted by serious infection(s), or any known severe illness(es) which are judged by the Investigator could interfere with subjects' safety and/or study evaluation.
10. Taking medication affecting the gastrointestinal system within 2 weeks prior to Screening, such as: prokinetics, acid release inhibitors (histamine-2-receptor \[H2\]- antagonists, proton pump inhibitors \[PPI\], or potassium-competitive acid blockers), gastric mucosa protectors (sucralfate, rebamipide), and any gastric-relevant herbal medicines.
11. Participation in any other clinical studies within 30 days prior to Screening.
18 Years
75 Years
ALL
No
Sponsors
Meet the organizations funding or collaborating on the study and learn about their roles.
Dexa Medica Group
INDUSTRY
Responsible Party
Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.
Principal Investigators
Learn about the lead researchers overseeing the trial and their institutional affiliations.
Ari F Syam, Prof, MD, Sp.PD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta Indonesia
Agasjtya W Wardhana, MD, Sp.PD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine Budhi Asih Hospital, East Jakarta, Indonesia
Nugroho B Santoso, MD, Sp.PD
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine Pasar Rebo Hospital, South Jakarta, Indonesia
Hery D Purnomo, Dr, MD, Sp.PD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine Dr. Kariadi General Hospital, Semarang, Indonesia
Triyanta Y Pramana, Dr, MD, Sp.PD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine Dr. Moewardi Hospital, Surakarta, Indonesia
Mulyana Edi, MD, Sp.PD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine Fatmawati General Hospital, Jakarta,
Coana Sukmagautama, MD, Sp.PD, M.Kes.
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine Universitas Sebelas Maret (UNS) Hospital, Sukoharjo, Indonesia
Ulfa Kholili, MD, Sp.PD-KGEH
Role: PRINCIPAL_INVESTIGATOR
Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia
Locations
Explore where the study is taking place and check the recruitment status at each participating site.
Department of Internal Medicine, Dr. Kariadi General Hospital
Semarang, Central Java, Indonesia
Department of Internal Medicine, Universitas Sebelas Maret (UNS) Hospital
Sukoharjo, Central Java, Indonesia
Department of Internal Medicine, Dr. Moewardi Hospital
Surakarta, Central Java, Indonesia
Department of Internal Medicine, Budhi Asih Hospital
Jakarta, DKI Jakarta, Indonesia
Department of Internal Medicine, Fatmawati General Hospital
Jakarta, DKI Jakarta, Indonesia
Department of Internal Medicine, Pasar Rebo Hospital
Jakarta, DKI Jakarta, Indonesia
Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia
Surabaya, East Java, Indonesia
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital
Jakarta, Jakarta Special Capital Region, Indonesia
Countries
Review the countries where the study has at least one active or historical site.
Central Contacts
Reach out to these primary contacts for questions about participation or study logistics.
Facility Contacts
Find local site contact details for specific facilities participating in the trial.
Coana Sukmagautama, MD, Sp.PD, M.Kes
Role: primary
Triyanta Y Pramana, Dr, MD, Sp.PD-KGEH
Role: primary
Edi Mulyana, MD, Sp.PD-KGEH
Role: primary
Nugroho B Santoso, MD, Sp.PD
Role: primary
Ulfa Kholili, MD, Sp.PD-KGEH
Role: primary
Other Identifiers
Review additional registry numbers or institutional identifiers associated with this trial.
DLBS2411-0419
Identifier Type: -
Identifier Source: org_study_id
More Related Trials
Additional clinical trials that may be relevant based on similarity analysis.