跳至主要内容
临床试验/NCT07578402
NCT07578402尚未招募4 期

Effect of Digestive Enzymes as Add on Therapy on Patients With Functional Dyspepsia - A Randomised, Open Label Trial

Rakibul Mostafa1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2026年5月15日最近更新:
适应症

试验速览

阶段
4 期
状态
尚未招募
发起方
入组人数
120
试验地点
1

研究概览

简要总结

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 70 Years(Adult, Older Adult)
性别
All
接受健康志愿者

入选标准

  • Age 18 years or more
  • Patients with FD diagnosed according to ROME IV criteria

排除标准

  • 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.

研究者

发起方
Rakibul Mostafa
申办方类型
Other
责任方
Sponsor Investigator
主要研究者

Rakibul Mostafa

Principle Investigator

Dhaka Medical College

研究点 (1)

Loading locations...

相似试验