Actively Recruiting
Efficacy of Carminal in Helicobacter Pylori Gastritis
Led by Catalysis SL · Updated on 2025-09-17
80
Participants Needed
2
Research Sites
61 weeks
Total Duration
On this page
AI-Summary
What this Trial Is About
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.
CONDITIONS
Official Title
Efficacy of Carminal in Helicobacter Pylori Gastritis
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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
You will not qualify if you...
- 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
- Patients with decompensated intercurrent illnesses including active infections, symptomatic congestive heart failure, unstable angina pectoris, cardiac arrhythmia, liver disease, psychiatric illnesses limiting adherence, or other conditions jeopardizing health
- Patients who are pregnant, breastfeeding, in postpartum period, or planning pregnancy during the trial
- Patients with human immunodeficiency virus (HIV) infection
AI-Screening
AI-Powered Screening
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Trial Site Locations
Total: 2 locations
1
Clinical Center of Serbia - Clinic for Gastroenterohepatology
Belgrade, Central Serbia, Serbia, 11000
Actively Recruiting
2
Zvezdara Medical Center - Department of Gastroenterology
Belgrade, Central Serbia, Serbia, 11000
Actively Recruiting
Research Team
D
Dragana Mijač, MD, PhD
CONTACT
How is the study designed?
Study Type
INTERVENTIONAL
Masking
TRIPLE
Allocation
RANDOMIZED
Model
PARALLEL
Primary Purpose
SUPPORTIVE_CARE
Number of Arms
2
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