NCT07179237 Efficacy of Carminal in Helicobacter Pylori Gastritis

Trial Parameters

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Brief Summary

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.

Eligibility Criteria

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 judg

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