Functional Dyspepsia
Conditions
Keywords
Functional Dyspepsia, Amitriptyline, Trifluoperazine, Neuromodulator, DGBI, Disorders of Gut Brain Interaction, ROME IV, 5-point Likert Scale, Tricyclic antidepressant, Phenothiazine, Antipsychotic, Dyspepsia
Brief 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. 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.
Interventions
DRUGTablet Amitriptyline 10 milligrams
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.
DRUGTablet Trifluoperazine 1 milligrams twice daily
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.
The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.
Sponsors
Md. Moktadirul Hoque Shuvo
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 60 Years
Healthy volunteers
No
Inclusion criteria
* 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
Exclusion criteria
* 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 * 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
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dyspeptic symptom | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| Compare the effects of amitriptyline and trifluoperazine | At baseline and then at week 4 and 8 after randomization | 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. |
| Adverse events | Through study completion, an average of 1 year | Patient reported adverse events will be documented |
| See the effect of amitriptyline compared to first line treatment only | At baseline and then at week 4 and 8 after randomization | 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. |
| See the effect of trifluoperazine compared to first line treatment only | At baseline and then at week 4 and 8 after randomization | 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. |
| Persistence of symptom improvement or recurrence of dyspeptic symptoms | At week 12 after randomization | 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. |
Countries
Bangladesh
Contacts
CONTACTMd. Moktadirul Hoque Shuvo, MBBS
Outcome results
None listed