Effect of Amitriptyline and Trifluoperazine on Patients With Functional Dyspepsia
试验速览
- 阶段
- 2 期
- 状态
- 招募中
- 发起方
- 入组人数
- 120
- 试验地点
- 2
- 主要终点
- Change in dyspeptic symptom
研究概览
简要总结
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 60 Years（Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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
研究组 & 干预措施
Amitriptyline
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.
干预措施: Tablet Amitriptyline 10 milligrams (Drug)
Trifluoperazine
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.
干预措施: Tablet Trifluoperazine 1 milligrams twice daily (Drug)
结局指标
主要结局
Change in dyspeptic symptom
时间窗: 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.
次要结局
- Adverse events(Through study completion, an average of 1 year)
- See the effect of trifluoperazine compared to first line treatment only(At baseline and then at week 4 and 8 after randomization)
- See the effect of amitriptyline compared to first line treatment only(At baseline and then at week 4 and 8 after randomization)
- Compare the effects of amitriptyline and trifluoperazine(At baseline and then at week 4 and 8 after randomization)
- Adverse events(Through study completion, an average of 1 year)
- Persistence of symptom improvement or recurrence of dyspeptic symptoms(At week 12 after randomization)
研究者
Md. Moktadirul Hoque Shuvo
Principal Investigator
Dhaka Medical College