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โ† Trials
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Efficacy of Carminal in Helicobacter Pylori Gastritis

RecruitingPhase 2Ages 18 Years - anyAllCatalysis SL
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In plain words

What the trial is, and whether it could suit you

Eighty patients will be included and randomized in two groups, one group (40 patients) will be administered 30 ml of the supplement Carminal, once a day, plus therapy for HP gastitis and the control group (40 patients) will be given standard therapy for HP gastritis with placebo. Treatment will begin after complection of upper endoscopy with histology results from biopted gastric mucosa. Treatment with Carminal will be continued after successful HP eradication during 12 weeks. The final evaluation will take place 12 weeks after the last Carminal intake, when control endoscopy with histology will be performed. The study will last approximately 24 weeks.

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๐Ÿ“‹ Eligibility rules (as published)
Inclusion Criteria: * Patients aged 18 years or older * Patients with clinical symptoms of dyspepsia * Patients diagnosed with Helicobacter pylori positive gastritis, confirmed by upper endoscopy with histology * Patients who give written informed consent to participate in the study Exclusion Criteria: * Patients with peptic ulcer disease * Patients with previous gastric surgery * Patients with current malignancy or the history of any previous malignancies * Patients taking another investigational product, or have taken any investigational product in the last year * Patients with known hypersensitivity to any ingredients found in the investigational product. * Decompensated intercurrent illnesses, including: active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, and psychiatric illnesses that may limit adherence to the requirements of the clinical trial, or any other special condition that, according to the physician's judgement, jeopardises the patient's health or life during participation in the trial. * Planned pregnancy for the duration of trial, pregnancy, breast feeding, or postpartum period. * Patients with human immunodeficiency virus (HIV).
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What it tests

  • Carminal Oral solution
  • Placebo
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Where

2 sites
Clinical Center of Serbia - Clinic for Gastroenterohepatology
Belgrade, Serbia
Zvezdara Medical Center - Department of Gastroenterology
Belgrade, Serbia
๐Ÿค Taking part is your choice, and you can leave at any time. Only the trial team can confirm you are eligible โ€” always decide together with your own doctor.
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