Clinical Trial of Efficacy and Safety of Kolofort in Functional Dyspepsia Patients
Condition: Dyspepsia
MeSH terms: Dyspepsia
Study type: Interventional
Phase: Phase 4

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

Detailed description: 
      Design: a multicenter double-blind placebo-controlled randomized clinical trial to evaluate
      the efficacy and safety of the study treatment.

      The study will enroll the patients of both genders aged 18-45 years old with verified
      diagnosis of "functional dyspepsia" according to Rome-IV criteria and intensity of dyspeptic
      symptoms ≥ 6 according to GIS (Gastrointestinal symptom score).

      At the screening visit 1 (Visit 1, from -14 to -1 days), after signing patient information
      sheet (informed consent form) to participate in the clinical trial, complaints and medical
      history are collected, an objective examination is performed. The investigator evaluates
      intensity of dyspeptic symptoms according to GIS. The patient undergoes an abdomen ultrasound
      examination, esophagogastroduodenoscopy (EGDS) , and diagnostic tests for Helicobacter pylori
      (H. pylori) infection. In case of the previous use of proton pump inhibitors, prokinetics,
      antispasmodics, antacids, bismuth drugs the investigator evaluates the possibility of
      canceling these drugs at least 7 days before the patient is randomized. For women of
      reproductive age, a pregnancy test is performed.

      On the day of randomization (Visit 2, Day 0) collection of complaints and objective
      examination are carried out. The investigator evaluates the results of laboratory and
      instrumental research methods, the severity of dyspepsia symptoms on the GIS scale, registers
      changes in concomitant therapy.

      If a patient meets all inclusion criteria and does not have any exclusion criteria, he/she is
      randomized into one of two groups: patients in Group 1 receive Kolofort for 8 weeks; patients
      in Group 2 - Placebo on the study drug regimen. The patient completes the Nepean Dyspepsia
      Index (NDI) and Quality of Life (SF-36) questionnaires.

      The patient's treatment lasts for 8 weeks, during which 3 visits to the research center are
      carried out. At Visit 3 (Week 2 ± 3 days), complaints are collected, an objective examination
      of the patient is performed. The investigator monitors the prescribed and concomitant
      therapy, evaluates the safety of therapy and the degree of adherence to treatment
      (compliance). At visit 4 (week 4±3 days) and 5 (week 8±3 days) the investigator collects
      complaints, registers the physical examination data, monitors the prescribed and concomitant
      therapy, assesses the safety of the treatment and compliance. Questionnaires GIS, NDI are
      filled in.

      Additionally, at Visit 5 the patient fills out the SF-36 scale, the investigator fills out
      the Clinical Global Impression-Efficacy Index (CGI-EI).

      The patients will be allowed to take symptomatic therapy and medications for their
      co-morbidities during the study, except for the medicines listed in "Prohibited Concomitant
      Treatment".
    

Intervention name(s): Kolofort; Placebo
Intervention type(s): Drug; Drug
Intervention description(s): Oral administration; Oral administration
Allocation: Randomized
Intervention model: Parallel Assignment
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary purpose: Treatment