The effect of eating and drinking modification and sumac in the treatment of dyspepsia

Phase 3

Recruiting

Conditions: Functional dyspepsia.
Functional dyspepsia

Registration Number: IRCT20200424047192N1

Lead Sponsor: Gorgan University of Medical Sciences

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 104

Inclusion Criteria

Patient age range between 18 and 60 years
Detection of functional dyspepsia (based on ROME III criteria)
Existence of normal endoscopy without specific pathological findings
The onset of symptoms is at least 6 months in advance and the presence of symptoms at least 3 days a week in the last three months
Absence of Helicobacter pylori infection
No history of treatment with antibiotics and PPIs during the last 1 month

Exclusion Criteria

Underlying diseases including heart failure; renal and hepatic failure; dirrhosis; diabetes, thyroid disorders
Smoking, drug or alcohol use
Consumption NSAIDs or aspirin
Pregnancy or breastfeeding

Study & Design

Study Type: interventional

Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
Total score of gastrointestinal symptom rating scale. Timepoint: At baseline, 2, 4 and 8 weeks after starting the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale (GSRS) questionnaire.;Quality of Life. Timepoint: At baseline, 2, 4 and 8 weeks after starting the intervention. Method of measurement: 10-item short form of Nepean Dyspepsia Index (NDI-10).;Eating and drinking habits. Timepoint: At baseline, 2, 4 and 8 weeks after starting the intervention. Method of measurement: Eating and drinking habits questionnaire.

Secondary Outcome Measures

Name	Time	Method
Drug side effects. Timepoint: During the intervention and up to one month after the end of the intervention. Method of measurement: Drug side effects questionnaire.