Status:
RECRUITING
Efficacy of Carminal in Helicobacter Pylori Gastritis
Lead Sponsor:
Catalysis SL
Conditions:
H Pylori Gastritis
H Pylori Infection
Eligibility:
All Genders
18+ years
Phase:
PHASE2
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 g...
Detailed Description
Helicobacter pylori-induced gastritis is an infectious disease based on objective pathological criteria. After the successful eradication of the infection, the recovery of the mucosa occurs through a ...
Eligibility Criteria
Inclusion
- 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
- 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).
Key Trial Info
Start Date :
August 4 2025
Trial Type :
INTERVENTIONAL
Allocation :
ESTIMATED
End Date :
October 5 2026
Estimated Enrollment :
80 Patients enrolled
Trial Details
Trial ID
NCT07179237
Start Date
August 4 2025
End Date
October 5 2026
Last Update
September 17 2025
Active Locations (2)
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1
Clinical Center of Serbia - Clinic for Gastroenterohepatology
Belgrade, Central Serbia, Serbia, 11000
2
Zvezdara Medical Center - Department of Gastroenterology
Belgrade, Central Serbia, Serbia, 11000