Functional DyspepsiaPhase 2/3NCT07008235
Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
A Phase 2/3 study testing Tablet Amitriptyline 10 milligrams, Tablet Trifluoperazine 1 milligrams twice daily and Standard First-Line Therapy in people with Functional Dyspepsia, run by Md. Moktadirul Hoque Shuvo at 1 site in Bangladesh.
Trial summary
The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Functional Dyspepsia
- What is being tested?
- Tablet Amitriptyline 10 milligrams, Tablet Trifluoperazine 1 milligrams twice daily and Standard First-Line Therapy
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 120 participants
- Where
- 1 siteBangladesh
- Study dates
- 1 Jul 2025to Jun 2026
- Phase
- Phase 2/3
- Are there results?
- Not yet: the study is under way
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 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Age 18 years or more
- Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria
- Patients who are willing to sign informed written consent
Who cannot join
- Structural lesion in Upper GI endoscopy and/or positive CLO test
- Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms
- History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders
- Previous history of gastrointestinal surgery
- Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine
- Any patient with ongoing treatment with antidepressants or antipsychotics
Show all 10Show fewer
- Any history of hypersensitivity, adverse effect, or ineffectiveness with amitriptyline or trifluoperazine
- Patients for whom Amitriptyline and Trifluoperazine are contraindicated
- Elderly patients> 60 years
- Pregnancy and breastfeeding
Trial locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
Bangladesh1 site, 1 recruiting
- Recruiting
Dhaka Medical College
Dhaka, 1000
Md. Moktadirul Hoque Shuvo, MBBS, +8801788450963, kdshuvo1430@gmail.com
About this study
The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are:
Does drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only.
Read more
Participants will:
Take drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.
- Conditions
- Functional Dyspepsia
- Being tested
- Tablet Amitriptyline 10 milligrams, Tablet Trifluoperazine 1 milligrams twice daily, Standard First-Line Therapy
- Keywords
- Functional Dyspepsia, Amitriptyline, Trifluoperazine, Neuromodulator, DGBI, Disorders of Gut Brain Interaction, ROME IV, 5-point Likert Scale, Tricyclic antidepressant, Phenothiazine, Antipsychotic, Dyspepsia
- Medical subject headings
- Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Tablet Amitriptyline 10 milligramsDrug
Tablet Amitriptyline 10 milligrams at night will be given to patients along with first line treatment (diet+lifestyle+PPI) of functional dyspepsia for 8 weeks after randomization. After that, the amitriptyline will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks.
Tablet Trifluoperazine 1 milligrams twice dailyDrug
Tablet Trifluoperazine 1 milligrams twice daily will be given to patients along with first line treatment (diet+lifestyle+PPI) of functional dyspepsia for 8 weeks after randomization. After that, the trifluoperazine will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks.
Standard First-Line TherapyDrug
The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.
| Study group | Role | What they receive |
|---|---|---|
| Amitriptyline | Experimental | Tab. Amitriptyline 10 milligrams at night along with first line treatment (diet+lifestyle+PPI) for 8 weeks after randomization. After that, the amitriptyline will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. Receives: Drug: Tablet Amitriptyline 10 milligrams |
| Trifluoperazine | Experimental | Tab. Trifluoperazine 1 milligrams twice daily along with first line treatment (diest+Lifestyle+PPI) for 8 weeks after randomization. After that, the trifluoperazine will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. Receives: Drug: Tablet Trifluoperazine 1 milligrams twice daily |
| Control Group | Active comparator | The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization. Receives: Drug: Standard First-Line Therapy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in dyspeptic symptom
The change of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome. Score 1or 2 in all four dyspepsia symptoms in a patient previously scored 3,4,5 in 5-point Likert scale at baseline is defined as response or symptom relief.
Measured: At baseline and then at week 4 and 8 after randomization
Secondary outcomes (5)
See the effect of trifluoperazine compared to first line treatment only
Effect of trifluoperazine on four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed and compared to first line treatment only by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome. Score 1or 2 in all four dyspepsia symptoms in a patient previously scored 3,4,5 in 5-point Likert scale at baseline is defined as response or symptom relief.
Measured: At baseline and then at week 4 and 8 after randomization
See the effect of amitriptyline compared to first line treatment only
Effect of amitriptyline on four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed and compared to first line treatment only by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome. Score 1or 2 in all four dyspepsia symptoms in a patient previously scored 3,4,5 in 5-point Likert scale at baseline is defined as response or symptom relief.
Measured: At baseline and then at week 4 and 8 after randomization
Compare the effects of amitriptyline and trifluoperazine
Effect of amitriptyline and trifluoperazine on four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed and compared by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome. Score 1or 2 in all four dyspepsia symptoms in a patient previously scored 3,4,5 in 5-point Likert scale at baseline is defined as response or symptom relief.
Measured: At baseline and then at week 4 and 8 after randomization
Adverse events
Patient reported adverse events will be documented
Measured: Through study completion, an average of 1 year
Persistence of symptom improvement or recurrence of dyspeptic symptoms
After 8 weeks of active intervention, all three groups will be kept on first line treatment only for additional 4 weeks. Change in symptom score and persistence of response or recurrence of four dyspeptic symptoms after discontinuation of neuromodulators (amitriptyline and trifluoperazine) will be assessed and compared by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome. Score 1or 2 in all four dyspepsia symptoms will be called persistence of response and score 3,4, or 5 in any symptom will be called recurrence in patients who responded by week 8.
Measured: At week 12 after randomization
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted6 Jun 2025
- Study start1 Jul 2025
- Primary completionJun 2026 (estimated)
- Study completionJun 2026 (estimated)
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 2/3
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Enrolment
- 120 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Md. Moktadirul Hoque Shuvo
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor-investigator, Md. Moktadirul Hoque Shuvo, Dhaka Medical College
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07008235
- Sponsor's protocol ID
- IRB-DMC/2025/38
- Status last verified
- May 2026
- First submitted
- 24 May 2025
- Last updated
- 7 May 2026
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
- ClinicalTrials.gov ID
- NCT07008235
- Acronym / sponsor ID
- IRB-DMC/2025/38
- Conditions
- Functional Dyspepsia
- Keywords
- Functional Dyspepsia, Amitriptyline, Trifluoperazine, Neuromodulator, DGBI, Disorders of Gut Brain Interaction, ROME IV, 5-point Likert Scale
- Phase
- Phase 2/3
- Study type
- Interventional
- Recruitment status
- Recruiting
- Enrolment
- 120 participants (estimated)
- Lead sponsor
- Md. Moktadirul Hoque ShuvoUniversity, hospital or other
- Study start
- 1 Jul 2025 (actual)
- Primary completion
- Jun 2026 (estimated)
- Study completion
- Jun 2026 (estimated)
- First posted
- 6 Jun 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.
The goal of this clinical trial is to assess and compare the effect of amitriptyline and trifluoperazine in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drugs amitriptyline and trifluoperazine by recording the patient reported adverse events. The main questions it aims to answer are:
Does drug amitriptyline and trifluoperazine has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug amitriptyline and trifluoperazine? Researcher will compare drug amitriptyline and trifluoperazine to a control group taking standard first line treatment only.
Participants will:
Take drug amitriptyline 10 milligrams at night or trifluoperazine 1 milligrams twice daily every day for 8 weeks along with standard first line treatment. A third group will be taken as control arm who will be kept on standard first line treatment only for 8 weeks. After that all three groups will be kept only on standard first line treatment for an additional 4 weeks. They will visit the hospital 4 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 4, 8, and 12. Additionally, patient reported adverse events will be documented.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- None (open label)
- Number of arms
- 3
| Arm | Type | Receives |
|---|---|---|
| Amitriptyline | Experimental | Drug: Tablet Amitriptyline 10 milligramsTab. Amitriptyline 10 milligrams at night along with first line treatment (diet+lifestyle+PPI) for 8 weeks after randomization. After that, the amitriptyline will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. |
| Trifluoperazine | Experimental | Drug: Tablet Trifluoperazine 1 milligrams twice dailyTab. Trifluoperazine 1 milligrams twice daily along with first line treatment (diest+Lifestyle+PPI) for 8 weeks after randomization. After that, the trifluoperazine will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. |
| Control Group | Active comparator | Drug: Standard First-Line TherapyThe first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (3 listed)
- Age 18 years or more
- Patients with symptoms of dyspepsia for duration consisted with ROME IV criteria
- Patients who are willing to sign informed written consent
Key exclusion criteria (10 listed)
- Structural lesion in Upper GI endoscopy and/or positive CLO test
- Patients scoring 1 or 2 on the 5-point Likert scale for all four dyspepsia symptoms
- History of malignancy, significant liver and biliary tract disease, hypertension, diabetes mellitus, chronic kidney disease, thyroid disorder, major psychiatric disorders
- Previous history of gastrointestinal surgery
- Patients those have to take any drug for other medical condition that may cause dyspepsia, can interfere or whose co-prescription is contraindicated with amitriptyline or trifluoperazine
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 |
|---|---|---|
| Tablet Amitriptyline 10 milligramsTablet Amitriptyline 10 milligrams at night will be given to patients along with first line treatment (diet+lifestyle+PPI) of functional dyspepsia for 8 weeks after randomization. After that, the amitriptyline will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. | Drug | Amitriptyline |
| Tablet Trifluoperazine 1 milligrams twice dailyTablet Trifluoperazine 1 milligrams twice daily will be given to patients along with first line treatment (diet+lifestyle+PPI) of functional dyspepsia for 8 weeks after randomization. After that, the trifluoperazine will be discontinued, and patients will be kept on first line treatment only for additional 4 weeks. | Drug | Trifluoperazine |
| Standard First-Line TherapyThe first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization. | Drug | Control Group |
Primary outcome
Change in dyspeptic symptom
Time frame: At baseline and then at week 4 and 8 after randomization
The change of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) will be assessed by a 5-point Likert Scale. The four main symptoms of dyspepsia, each will be graded as 1 (No problem), 2 (Mild problem, can be ignored when not thinking about it), 3 (Moderate problem, cannot be ignored but does not influence daily activities), 4 (Severe Problem, influences concentration on daily activities), 5 (Very severe problem, markedly influences daily activities or requires rest or both). The total minimum value is 4 and maximum value is 20. Higher score means worse outcome. Score 1or 2 in all four dyspepsia symptoms in a patient previously scored 3,4,5 in 5-point Likert scale at baseline is defined as response or symptom relief.
5 secondary outcomes
See the effect of trifluoperazine compared to first line treatment only
Time frame: At baseline and then at week 4 and 8 after randomization
See the effect of amitriptyline compared to first line treatment only
Time frame: At baseline and then at week 4 and 8 after randomization
Compare the effects of amitriptyline and trifluoperazine
Time frame: At baseline and then at week 4 and 8 after randomization
Adverse events
Time frame: Through study completion, an average of 1 year
Persistence of symptom improvement or recurrence of dyspeptic symptoms
Time frame: At week 12 after randomization
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 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.
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A Phase 2/3 study testing Tablet Amitriptyline 10 milligrams, Tablet Trifluoperazine 1 milligrams twice daily and Standard First-Line Therapy in people with Functional Dyspepsia, run by Md. Moktadirul Hoque Shuvo at 1 site in Bangladesh.
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 3 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: looking for participants now, as of the sponsor's last update on 7 May 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 Bangladesh. 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 combined 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.
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?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Md. Moktadirul Hoque Shuvo, MBBS (+8801788450963, kdshuvo1430@gmail.com), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Change in dyspeptic symptom (time frame: At baseline and then at week 4 and 8 after randomization). 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 7 May 2026.