Functional DyspepsiaPhase 3NCT05248802
DLBS2411 Treatment For Functional Dyspepsia
A Phase 3 study testing DLBS2411 in people with Functional Dyspepsia, run by Dexa Medica Group at 8 sites in Indonesia.
Trial summary
This is a 2-arm, prospective, double-blind, randomized and placebo-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), for a 4-week course of therapy, for the treatment of patients with functional dyspepsia (FD), and an additional 8 weeks after end of therapy (Week 12)… Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- DLBS2411
- Could I receive a placebo?
- Yes, some participants may receive a placebo
- How many people
- 106 participants
- Where
- 8 sitesIndonesia
- Study dates
- 9 Dec 2022to 1 Oct 2025
- Phase
- Phase 3
- 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 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Signed informed consent prior to participation in the study.
- Male or female subjects aged of 18 - 75 years old.
- Meet Rome IV criteria for FD, which includes:
- One or more of the following symptoms:
- bothersome postprandial fullness
- early satiation, that prevents finishing a regular meal, at least several times per week.
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- 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.
- 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.
- Subjects who tested negative for Helicobacter pylori by urea breath-test, histological or rapid test during the screening period.
- Able to take oral medication.
Who cannot join
- Pregnancy, breast-feeding females.
- Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactive result) for SARS-COV-2.
- 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.
- History of or known or suspected Zollinger Ellison syndrome.
- History of or known gastrointestinal malignancy or ulcers associated to malignancy.
- Hepatic cirrhosis or abnormal liver laboratory findings (defined as >3xULN of ALT or AST).
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- Being under hemodialysis therapy or having advanced chronic kidney disease (defined as eGFR <60 mL/min).
- 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%).
- 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.
- 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.
- Participation in any other clinical studies within 30 days prior to Screening.
Trial locations and contacts
8 sites in 1 country.
8 sites in 1 country
Indonesia8 sites
Department of Internal Medicine, Budhi Asih Hospital
Jakarta, DKI Jakarta
Department of Internal Medicine, Fatmawati General Hospital
Jakarta, DKI Jakarta
Department of Internal Medicine, Pasar Rebo Hospital
Jakarta, DKI Jakarta
Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital
Jakarta, Jakarta Special Capital Region, 10430
Department of Internal Medicine, Dr. Kariadi General Hospital
Semarang, Central Java
Department of Internal Medicine, Universitas Sebelas Maret (UNS) Hospital
Sukoharjo, Central Java
Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia
Surabaya, East Java
Department of Internal Medicine, Dr. Moewardi Hospital
Surakarta, Central Java
About this study
Official title: Randomized Controlled Trial of DLBS2411 Treatment For Functional Dyspepsia
This is a 2-arm, prospective, double-blind, randomized and placebo-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), for a 4-week course of therapy, for the treatment of patients with functional dyspepsia (FD), and an additional 8 weeks after end of therapy (Week 12) for follow-up visit.
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).
Read the detailed description
Study population will be patients with functional dyspepsia (FD) who come to the study site. There will be 100 subjects (50 subjects in each group) planned to be enrolled in the study.
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
- Functional Dyspepsia
- Being tested
- Placebo caplet of DLBS2411, DLBS2411
- Keywords
- Functional Dyspepsia, DLBS2411, Epigastric Pain Syndrome, Postprandial Distress Syndrome
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Placebo caplet of DLBS2411Drug
Also called Placebo caplet of Redacid
1 caplet of placebo DLBS2411, twice daily
DLBS2411Drug
Also called Redacid
1 caplet of DLBS2411 250 mg, twice daily
| Study group | Role | What they receive |
|---|---|---|
| Control | Placebo comparator | Placebo DLBS2411 2 x 1 caplet daily, given everyday for 4 weeks of study period Receives: Drug: Placebo caplet of DLBS2411 |
| DLBS2411 | Experimental | DLBS2411 caplet 2 x 250 mg daily, given everyday for 4 weeks of study period Receives: Drug: DLBS2411 |
What is being measured
The primary outcome is the main question the study is designed to answer.
Short-Form Nepean Dyspepsia Index (SF-NDI)
Change of disease specific quality of life as measured by short-form NDI (SF-NDI) after 4 weeks of therapy (Week 4).
The SF-NDI consists of 10 quality-of-life (QoL)-items, each of which is measured by 5-point Likert scales from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely). The lower score indicates an improved outcome.
Measured: Week 4
Secondary outcomes (4)
Short-Form Nepean Dyspepsia Index (SF-NDI)
Change of disease specific quality of life as measured by short-form NDI (SF-NDI) after 2 weeks of therapy (Week 2) and additional 8 weeks after end of therapy (Week 12).
The SF-NDI consists of 10 quality-of-life (QoL)-items, each of which is measured by 5-point Likert scales from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely). The lower score indicates an improved outcome.
Measured: Week 2 and 12
Visual Analogue Scale (VAS)
Change of the individual symptom intensity as indicated by Visual Analogue Scale (VAS) reduction after 2 and 4 weeks of therapy and 8 weeks after the end of therapy (Week 2, 4 and 12, respectively).
The VAS of pain intensity is rated from 0 to 100 on a 100-mm line, with the end points indicating: no pain (0) and the worst pain it could possible be (100).
Measured: Week 2, 4, and 12
The proportion of subjects reaching adequate / satisfactory relief from FD symptoms
The proportion of subjects reaching adequate / satisfactory relief from FD symptoms based on subjects" subjective evaluation on overall symptom relief at Week 2, Week 4 and additional 8 weeks after end of therapy (Week 12)
Measured: Week 2, 4, and 12
Number of adverse event during the study
Number of adverse event during the study will be observed throughout the study conduct
Measured: Week 2, 4, and 12
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Feb 2022
- Study start9 Dec 2022
- Primary completion1 Oct 2025
- Study completion1 Oct 2025
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Functional DyspepsiaStudies 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 3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind
- Who is masked
- Participant, Care provider, Investigator, Outcomes assessor
- Enrolment
- 106 participants (actual)
Sponsor and investigators
- Lead sponsor
- Dexa Medica Group
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Ari F Syam, Prof, MD, Sp.PD-KGEH, Principal investigator, Division of Gastroenterology Department of Internal Medicine Faculty of Medicine, University of Indonesia Dr. Cipto Mangunkusumo National General Hospital, Jakarta IndonesiaAgasjtya W Wardhana, MD, Sp.PD-KGEH, Principal investigator, Department of Internal Medicine Budhi Asih Hospital, East Jakarta, IndonesiaNugroho B Santoso, MD, Sp.PD, Principal investigator, Department of Internal Medicine Pasar Rebo Hospital, South Jakarta, IndonesiaHery D Purnomo, Dr, MD, Sp.PD-KGEH, Principal investigator, Department of Internal Medicine Dr. Kariadi General Hospital, Semarang, IndonesiaTriyanta Y Pramana, Dr, MD, Sp.PD-KGEH, Principal investigator, Department of Internal Medicine Dr. Moewardi Hospital, Surakarta, IndonesiaMulyana Edi, MD, Sp.PD-KGEH, Principal investigator, Department of Internal Medicine Fatmawati General Hospital, Jakarta,Coana Sukmagautama, MD, Sp.PD, M.Kes., Principal investigator, Department of Internal Medicine Universitas Sebelas Maret (UNS) Hospital, Sukoharjo, IndonesiaUlfa Kholili, MD, Sp.PD-KGEH, Principal investigator, Department of Internal Medicine, Dr. Soetomo General Hospital, Surabaya, Indonesia
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT05248802
- Sponsor's protocol ID
- DLBS2411-0419
- Status last verified
- Feb 2026
- First submitted
- 26 Jan 2022
- Last updated
- 17 Feb 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 17 Feb 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Randomized Controlled Trial of DLBS2411 Treatment For Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT05248802
- Acronym / sponsor ID
- DLBS2411-0419
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, DLBS2411, Epigastric Pain Syndrome, Postprandial Distress Syndrome
- Phase
- Phase 3
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 106 participants (actual)
- Lead sponsor
- Dexa Medica GroupIndustry (pharma, biotech, devices)
- Study start
- 9 Dec 2022 (actual)
- Primary completion
- 1 Oct 2025 (actual)
- Study completion
- 1 Oct 2025 (actual)
- First posted
- 21 Feb 2022 (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 is a 2-arm, prospective, double-blind, randomized and placebo-controlled study using DLBS2411 at a dose of 250 mg twice daily (before morning and evening meals), for a 4-week course of therapy, for the treatment of patients with functional dyspepsia (FD), and an additional 8 weeks after end of therapy (Week 12) for follow-up visit.
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).
Detailed description
Study population will be patients with functional dyspepsia (FD) who come to the study site. There will be 100 subjects (50 subjects in each group) planned to be enrolled in the study.
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).
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Quadruple blind (participant, care provider, investigator, outcomes assessor)
- Number of arms
- 2
| Arm | Type | Receives |
|---|---|---|
| Control | Placebo comparator | Drug: Placebo caplet of DLBS2411Placebo DLBS2411 2 x 1 caplet daily, given everyday for 4 weeks of study period |
| DLBS2411 | Experimental | Drug: DLBS2411DLBS2411 caplet 2 x 250 mg daily, given everyday for 4 weeks of study period |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (10 listed)
- Signed informed consent prior to participation in the study.
- Male or female subjects aged of 18 - 75 years old.
- Meet Rome IV criteria for FD, which includes:
- Subjects who tested negative for Helicobacter pylori by urea breath-test, histological or rapid test during the screening period.
- Able to take oral medication.
Key exclusion criteria (11 listed)
- Pregnancy, breast-feeding females.
- Subjects suspected COVID-19 by clinical symptoms and rapid antigen test (reactive result) for SARS-COV-2.
- 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.
- History of or known or suspected Zollinger Ellison syndrome.
- History of or known gastrointestinal malignancy or ulcers associated to malignancy.
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 caplet of DLBS2411Also: Placebo caplet of Redacid1 caplet of placebo DLBS2411, twice daily | Drug | Control |
| DLBS2411Also: Redacid1 caplet of DLBS2411 250 mg, twice daily | Drug | DLBS2411 |
Primary outcome
Short-Form Nepean Dyspepsia Index (SF-NDI)
Time frame: Week 4
Change of disease specific quality of life as measured by short-form NDI (SF-NDI) after 4 weeks of therapy (Week 4). The SF-NDI consists of 10 quality-of-life (QoL)-items, each of which is measured by 5-point Likert scales from 0 (not at all or not applicable), 1 (a little), 2 (moderately), 3 (quite a lot) to 4 (extremely). The lower score indicates an improved outcome.
4 secondary outcomes
Short-Form Nepean Dyspepsia Index (SF-NDI)
Time frame: Week 2 and 12
Visual Analogue Scale (VAS)
Time frame: Week 2, 4, and 12
The proportion of subjects reaching adequate / satisfactory relief from FD symptoms
Time frame: Week 2, 4, and 12
Number of adverse event during the study
Time frame: Week 2, 4, and 12
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 17 Feb 2026.
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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.
Ari F Syam, Prof, MD, Sp.PD-KGEH 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 principal investigator
Department of Internal Medicine Budhi Asih Hospital, East Jakarta, Indonesia
Nugroho B Santoso, MD, Sp.PD principal investigator
Department of Internal Medicine Pasar Rebo Hospital, South Jakarta, Indonesia
8 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 3 study testing DLBS2411 in people with Functional Dyspepsia, run by Dexa Medica Group at 8 sites 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 10 inclusion and 11 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 17 Feb 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 8 sites 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 3 studies compare the treatment with the current standard treatment or a placebo in a large group, to confirm how well it works and watch for side effects.
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?
Short-Form Nepean Dyspepsia Index (SF-NDI) (time frame: Week 4). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
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 17 Feb 2026.