Dyspepsia, Epigastric Fullness, Epigastric Pain Syndrome, Functioanl Dyspepsia
Conditions
Keywords
Dyspepsia, Post parendial distress syndrome (PPDS), Epigastric pain syndrome (EPS), Functional dyspepsia (FD), Disorder of gut brain interaction (DGBI)
Brief summary
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.
Interventions
DRUGDigestive enzyme 325mg
Digestive enzyme will be given to group A patient
DRUGPPI 20 mg + Domperidone 10 mg
Group B patient will get first line treatment only for 1 month
Sponsors
Rakibul Mostafa
Study design
Allocation
RANDOMIZED
Intervention model
PARALLEL
Primary purpose
TREATMENT
Masking
NONE
Eligibility
Sex/Gender
ALL
Age
18 Years to 70 Years
Healthy volunteers
Yes
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.
Design outcomes
Primary
| Measure | Time frame | Description |
|---|---|---|
| Change in dyspeptic symptom | 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. |
Secondary
| Measure | Time frame | Description |
|---|---|---|
| See the effect of digestive enzymes compared to first line treatment only | 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. |
| Adverse events | Through study completion, an average of 1 year | Patient reported adverse events will be documented |
| Persistence of symptom improvement or recurrence of dyspeptic symptoms | 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. |
Countries
Bangladesh
Contacts
CONTACTRakibul Mostafa
Outcome results
None listed