Evaluation of the Efficacy of Carminal on the Gastric Mucosa in Patients With Helicobacter Pylori Positive Gastritis

Status: Recruiting
Location: See all (2) locations...
Intervention Type: Other, Dietary supplement
Study Type: Interventional
Study Phase: Phase 2
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
Participation Requirements
Sex: All
Minimum Age: 18
Healthy Volunteers: f
View:

• 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

Locations
Other Locations
Serbia
Clinical Center of Serbia - Clinic for Gastroenterohepatology
RECRUITING
Belgrade
Zvezdara Medical Center - Department of Gastroenterology
RECRUITING
Belgrade
Contact Information
Primary
Dragana Mijač, MD, PhD
draganamijac@gmail.com
+381 11 3088672
Time Frame
Start Date: 2025-08-04
Estimated Completion Date: 2026-10-05
Participants
Target number of participants: 80
Treatments
Experimental: Carminal Group
Participants in this arm (n=40) will receive:~Carminal oral solution, 30 ml once daily (1 vial BID), administered for 14 days during standard Helicobacter pylori eradication therapy.~Following successful eradication, Carminal treatment will continue for 12 additional weeks.~Carminal is a supplement containing Aloe vera extract, olive extract, glutamic acid, zinc, and other components with potential antioxidant, anti-inflammatory, and immunomodulatory effects on gastric mucosa.~The intervention aims to support mucosal recovery post-eradication and improve dyspeptic symptoms.
Placebo_comparator: Placebo Group
Participants in this arm (n=40) will receive:~Placebo, matched in appearance and administration schedule to Carminal, for 14 days during standard H. pylori eradication therapy.~Following successful eradication, placebo treatment will continue for 12 additional weeks.~This arm serves as the control group to evaluate the efficacy of Carminal in mucosal recovery and symptom improvement.
Sponsors
Leads: Catalysis SL

This content was sourced from clinicaltrials.gov

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