Efficacy of Carminal in Helicobacter Pylori Gastritis
Evaluation of the Efficacy of Carminal on the Gastric Mucosa in Patients With Helicobacter Pylori Positive Gastritis
Catalysis SL
80 participants
Aug 4, 2025
INTERVENTIONAL
Conditions
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
Inclusion Criteria4
- 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 Criteria8
- 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).
Interested in this trial?
Get notified about updates and connect with the research team.
Interventions
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 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)
View Full Details on ClinicalTrials.gov
For the most up-to-date information, visit the official listing.
NCT07179237