Evaluation of Carminal Supplement Effects on Gastric Mucosa in Patients with Helicobacter Pylori Positive Gastritis

What this Trial Is About

Researchers are studying patients with Helicobacter pylori positive gastritis to evaluate the effects of a supplement called Carminal on gastric mucosa recovery after eradication of the infection. The study focuses on how Carminal, which contains Aloe vera extract and other substances with potential antioxidant and anti-inflammatory properties, may influence healing and symptoms related to this condition. The trial is conducted under strict protocols and compliance with Good Clinical Practice in Serbia. Participants are randomly assigned to one of two groups: one receives Carminal oral solution at 30 ml once daily for 14 days alongside standard Helicobacter pylori eradication therapy, then continues Carminal for 12 more weeks after successful eradication. The other group receives a placebo matched in appearance and schedule, following the same treatment timeline. The treatment period lasts about 24 weeks, including initial therapy and follow-up. During the study, participants undergo upper endoscopy with histology at the start and end of treatment to assess the gastric mucosa. Researchers measure dyspepsia severity using validated scores at multiple time points, track Helicobacter pylori status, and record patient satisfaction and any adverse events throughout the trial. The final evaluation occurs 12 weeks after the last dose of Carminal or placebo, including control endoscopy and histological assessment to monitor mucosal recovery and symptom changes.

Efficacy of Carminal in Helicobacter Pylori Gastritis