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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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Tablet Amitriptyline 10 milligrams | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | At baseline and then at week 4 and 8 after randomization |
| Measure | Description | Time Frame |
|---|---|---|
| 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. |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Md. Moktadirul Hoque Shuvo, MBBS | Contact | +8801788450963 | kdshuvo1430@gmail.com |
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| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Dhaka Medical College | Recruiting | Dhaka | 1000 | Bangladesh |
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| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
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| Tablet Trifluoperazine 1 milligrams twice daily | Drug | 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. |
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| Standard First-Line Therapy | Drug | The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization. |
|
| 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. | 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. | At baseline and then at week 4 and 8 after randomization |
| Adverse events | Patient reported adverse events will be documented | 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. | At week 12 after randomization |