Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia.
2026年5月5日 更新者：Rakibul Mostafa
Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial
The goal of this clinical trial is to assess the effect of digestive enzymes in improving dyspeptic symptoms in patients with functional dyspepsia. It will also assess about the safety of drug by recording the patient reported adverse events. The main questions it aims to answer are:
Does drug digestive enzymes has any effect on patients with functional dyspepsia? What medical problems do participants have when taking drug digestive enzymes? Researcher will compare drug digestive enzymes to a control group taking standard first line treatment only.
Participants will:
Take drug digestive enzymes 325 milligrams 3 times daily, every day for 4 weeks along with standard first line treatment. A second group will be taken as control arm who will be kept on standard first line treatment only for 4 weeks. They will visit the hospital 2 weekly, and their symptoms will be assessed by a 5-point Likert Scale at baseline, week 2 and 4. Additionally, patient reported adverse events will be documented.
研究概览
地位
尚未招聘
研究类型
介入性
注册 (估计的)
120
阶段
- 第四阶段
联系人和位置
本节提供了进行研究的人员的详细联系信息，以及有关进行该研究的地点的信息。
学习联系方式
- 姓名：Rakibul Mostafa
- 电话号码：+8801837031585
- 邮箱：rakibmasuk96@gmail.com
学习地点
-
-
-
Dhaka、孟加拉国、1000
- Dhaka Medical College
-
接触：
- Rakibul Mostafa
- 电话号码：+8801837031585
- 邮箱：rakibmasuk96@gmail.com
-
-
参与标准
研究人员寻找符合特定描述的人，称为资格标准。这些标准的一些例子是一个人的一般健康状况或先前的治疗。
资格标准
适合学习的年龄
- 成人
- 年长者
接受健康志愿者
是的
描述
Inclusion Criteria:
- Age 18 years or more
- Patients with FD diagnosed according to ROME IV criteria
Exclusion Criteria:
- Structural lesion in endoscopy and positive H. pylori status
- History of malignancy, liver and biliary tract disease, diabetes mellitus, chronic kidney disease, thyroid disorders
- Psychiatric disorders
- Previous history gastrointestinal surgery
- Any history of hypersensitivity, adverse effect, or ineffectiveness with digestive enzyme
- Pregnancy and breastfeeding.
学习计划
本节提供研究计划的详细信息，包括研究的设计方式和研究的衡量标准。
研究是如何设计的？
设计细节
- 主要用途：治疗
- 分配：随机化
- 介入模型：并行分配
- 屏蔽：无（打开标签）
武器和干预
参与者组/臂 |
干预/治疗 |
|---|---|
|
实验性的：Group-A
Drug: Digestive enzyme 325mg + first line treatment This group will get digestive enzyme 325 mg 3 times daily along with first line treatment (PPI 20 mg twice daily and Prokinetics such domperidone 10mg three time daily) for 1 month
|
Digestive enzyme will be given to group A patient
|
|
有源比较器：Group-B
Drug: First line treatment only This group will get first line treatment only ( PPI 20 mg twice daily and prokinetics such as domperidone 10 mg 3 times daily) for 1 month
|
Group B patient will get first line treatment only for 1 month
|
研究衡量的是什么？
主要结果指标
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
Change in dyspeptic symptom
大体时间：At baseline and then at week 2 and 4 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.
|
At baseline and then at week 2 and 4 after randomization
|
次要结果测量
结果测量 |
措施说明 |
大体时间 |
|---|---|---|
|
不利事件
大体时间：通过学习完成，平均1年
|
患者报告的不良事件将记录在案
|
通过学习完成，平均1年
|
|
See the effect of digestive enzymes compared to first line treatment only
大体时间：At baseline and then at week 2 and 4 after randomization
|
Effect of digestive enzymes 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.
|
At baseline and then at week 2 and 4 after randomization
|
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Persistence of symptom improvement or recurrence of dyspeptic symptoms
大体时间：At week 8 after randomization
|
Persistence of symptom improvement or recurrence of four dyspeptic symptoms (Postprandial fullness, Early Satiety, Epigastric pain, Epigastric burning) after discontinuation of digestive enzymes 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.
|
At week 8 after randomization
|
合作者和调查者
在这里您可以找到参与这项研究的人员和组织。
研究记录日期
这些日期跟踪向 ClinicalTrials.gov 提交研究记录和摘要结果的进度。研究记录和报告的结果由国家医学图书馆 (NLM) 审查，以确保它们在发布到公共网站之前符合特定的质量控制标准。
研究主要日期
学习开始 (估计的)
2026年5月15日
初级完成 (估计的)
2026年12月31日
研究完成 (估计的)
2027年2月28日
研究注册日期
首次提交
2026年5月5日
首先提交符合 QC 标准的
2026年5月5日
首次发布 (实际的)
2026年5月11日
研究记录更新
最后更新发布 (实际的)
2026年5月11日
上次提交的符合 QC 标准的更新
2026年5月5日
最后验证
2026年5月1日
更多信息
与本研究相关的术语
关键字
其他研究编号
- IRB-DMC/2025/258
计划个人参与者数据 (IPD)
计划共享个人参与者数据 (IPD)？
不
药物和器械信息、研究文件
研究美国 FDA 监管的药品
不
研究美国 FDA 监管的设备产品
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