Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia

Обзор

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.

Вмешательства

• Препарат Tablet 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.
• Препарат Tablet 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.
• Препарат Standard First-Line Therapy
  The first line treatment (Diet+Lifestyle+PPI) of functional dyspepsia will be given to patients for 12 weeks (8 weeks+4weeks) after randomization.

Первичные конечные точки

• Change in dyspeptic symptom [Срок оценки: At baseline and then at week 4 and 8 after randomization]

Вторичные конечные точки (5)

• See the effect of trifluoperazine compared to first line treatment only [Срок оценки: At baseline and then at week 4 and 8 after randomization]
• See the effect of amitriptyline compared to first line treatment only [Срок оценки: At baseline and then at week 4 and 8 after randomization]
• Compare the effects of amitriptyline and trifluoperazine [Срок оценки: At baseline and then at week 4 and 8 after randomization]
• Adverse events [Срок оценки: Through study completion, an average of 1 year]
• Persistence of symptom improvement or recurrence of dyspeptic symptoms [Срок оценки: At week 12 after randomization]

Критерии участия

Критерии включения

• 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

Критерии исключения

• 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

Критерии приведены из реестра в оригинале (на английском). Окончательную оценку соответствия проводит исследовательский центр.

Здоровые добровольцы: Нет

Дизайн исследования

Распределение

Рандомизированное

Модель

Параллельные группы

Маскирование

Открытое

Основная цель

Лечение

Центры проведения

Bangladesh · 1 центр

• Dhaka Medical College — Dhaka

Идентификаторы

NCT: NCT07008235 · IRB-DMC/2025/38

Первоисточники (государственные реестры)

• ClinicalTrials.gov (NIH, США)

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