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Efficacy of Carminal in Helicobacter Pylori Gastritis
Sponsor: Catalysis SL
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.
Official title: Evaluation of the Efficacy of Carminal on the Gastric Mucosa in Patients With Helicobacter Pylori Positive Gastritis
Key Details
Gender
All
Age Range
18 Years - Any
Study Type
INTERVENTIONAL
Enrollment
80
Start Date
2025-08-04
Completion Date
2026-10-05
Last Updated
2025-09-17
Healthy Volunteers
No
Conditions
Interventions
Carminal Oral solution
Carminal is an oral dietary supplement presented in 30 ml vials, administered once daily (1 vial BID). It contains Aloe vera extract, olive extract, glutamic acid, zinc, and other components with potential antioxidant, anti-inflammatory, and immunomodulatory effects on gastric mucosa. In this study, Carminal is administered for 14 days during standard Helicobacter pylori eradication therapy, followed by 12 weeks of continued treatment post-eradication to support mucosal recovery and improve dyspeptic symptoms.
Placebo
Placebo is an oral solution presented in 30 ml vials, identical in appearance, taste, color, and smell to Carminal, but without any active ingredients. It is administered once daily (1 vial BID) for 14 days during standard Helicobacter pylori eradication therapy, followed by 12 weeks of continued placebo treatment post-eradication. This comparator is used to evaluate the efficacy of Carminal in mucosal recovery and symptom improvement in patients with H. pylori positive gastritis.
Locations (2)
Clinical Center of Serbia - Clinic for Gastroenterohepatology
Belgrade, Central Serbia, Serbia
Zvezdara Medical Center - Department of Gastroenterology
Belgrade, Central Serbia, Serbia