Ghors-Gol-Mohammadi in functional dyspepsia
Phase 3
Recruiting
- Conditions
- Functional dyspepsia.Functional dyspepsia
- Registration Number
- IRCT20221209056758N1
- Lead Sponsor
- Babol University of Medical Sciences
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 70
Inclusion Criteria
Patients with complaints of Functional dyspepsia
Diagnosis of functional dyspepsia based on ROME IV criteria by gastroenterologist
Helicobacter pylori infection positive test
Exclusion Criteria
History of peptic ulcer or reflux disease
Endoscopy with specific pathological findings
The presence of underlying diseases including heart failure, high blood pressure, kidney failure and uremic disease, cirrhosis
History of abdominal surgery
Any type of malignancy, history of chemotherapy and radiotherapy or exposure to radioactive radiation
Pregnancy and breastfeeding
Helicobacter pylori infection negative test
NSAIDs or any herbal medicine use
Smoking and alcohol consumption
History of any sensitivity to formulation components
Study & Design
- Study Type
- interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method The effect of «Ghors-Gol-mohammadi» on the severity of Functiona dyspepsia symptoms based on the total score of the GSRS questionnaire. Timepoint: At the beginning of the study, the second, fourth, sixth and eighth weeks from the beginning of the intervention. Method of measurement: Gastrointestinal Symptom Rating Scale questionnaire.
- Secondary Outcome Measures
Name Time Method The effect of Ghors-Gol-mohammadi on the severity of gastrointestinal symptoms in each of the 5 subgroups of symptoms of the Gastrointestinal Symptom Rating Scale questionnaire and the symptoms related to postprandial distress syndrome. Timepoint: Before starting the intervention, the second, fourth, and eighth following weeks. Method of measurement: Gastrointestinal Symptom Rating Scale.;Score of quality of life. Timepoint: before the starting the intervention and at the eighth week. Method of measurement: Persian Nepean Quality of Life Questionnaire (NDI-10).;Helicobacter pylori infection. Timepoint: Before the starting of the study and at the sixth week. Method of measurement: Urea breath test.