Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients
Condition: Dyspepsia
MeSH terms: Dyspepsia
Intervention: Kolofort; Placebo
Intervention description: Oral administration; Oral administration
Phase: Phase 4
Study type: Interventional
Primary purpose: Treatment
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Enrollment: 370.0
Sex: All
Minimum age: 18 Years
Maximum age: 45 Years
Healthy volunteers: No

Summary:

      Purpose of the study:

      To obtain additional data on efficacy and safety of Kolofort in the treatment of patients
      with functional dyspepsia.
    

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).