Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 4:09 PM
Ignite Modification Date:
2025-12-24 @ 4:09 PM
NCT ID:
NCT03119766
Eligibility Criteria:
Inclusion Criteria:
1. Patients of both genders aged 18-45 years old.
2. Diagnosis of functional dyspepsia established according to Rome-IV criteria (2016).
3. Severity of symptoms of dyspepsia ≥ 6 on the GIS scale.
4. Negative test result for H. pylori infection .
5. Availability of signed patient information sheet and informed consent form for participation in the clinical trial.
6. Patients who gave their consent to use reliable contraception during the study
Exclusion Criteria:
1. Organic diseases of the gastrointestinal tract (gastroesophageal reflux disease (GERD), peptic ulcer, chronic pancreatitis, cholelithiasis, hepatosis, hepatitis, hepatic cirrhosis, etc.)
2. Verified diagnosis of other functional GI diseases, i.e. biliary dyskinesia, irritable bowel syndrome, etc.
3. Discontinuation of proton pump inhibitors, prokinetics, antispasmodics, antacids, bismuth preparations less than 7 days before randomization.
4. H. pylori eradication within 2 months prior to enrollment.
5. Intestinal infection within 2 months prior to enrollment.
6. History/suspicion of oncology of any location.
7. Previously diagnosed cardiovascular diseases with functional class IV (according to the classification of the New-York Heart Association, 1964), hypothyroidism, diabetes mellitus, chronic renal disease С3-5, hepatic diseases with portal hypertension and/or signs of severe decompensation of function (\> 6 points according to the Child-Pugh classification).
8. Any other severe comorbidity that, in the opinion of the investigator, may affect patient participation in the clinical trial.
9. Allergy/intolerance intolerances to any of the components of the study drugs.
10. Pregnancy, breast-feeding.
11. Patients who, from the investigator's point of view, will not comply with the observation requirements of the study or adhere to study drug dosing regimens.
12. Scheduled hospitalization during the study for any diagnostic or therapeutic procedures.
13. Use of drugs or alcohol (more than 2 alcohol units daily), presence of mental diseases.
14. Use of any medications specified in the "Prohibited Concomitant Treatment" within 1 month prior to inclusion in the study.
15. Participation in other clinical trials in the previous 3 months.
16. Patients who are related to any of the on-site research personnel directly involved in the conduct of the trial or are an immediate relative of the study investigator. 'Immediate relative' means husband, wife, parent, son, daughter, brother, or sister (regardless of whether they are natural or adopted).
17. Patients who work for MATERIA MEDICA HOLDING (i.e. the company's employees, temporary contract workers, appointed officials responsible for carrying out the research or immediate relatives of the aforementioned).
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
45 Years
Study:
NCT03119766
Study Brief:
Protocol Section:
NCT03119766