Carminal for H. pylori gastritis

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

Eighty adults with dyspepsia and histologically confirmed H. pylori gastritis will be randomized 1:1 to receive either 30 ml daily of the oral supplement Carminal plus standard H. pylori therapy or placebo plus standard therapy. Treatment is started after diagnostic upper endoscopy with biopsy and continued for 12 weeks after confirmed H. pylori eradication, with the full study lasting about 24 weeks. The primary outcome is mucosal healing assessed by follow-up endoscopy and histology performed after the treatment period. The trial is interventional, phase 2, and designed to detect whether adding this antioxidant Aloe vera–based supplement improves gastric mucosal recovery beyond standard eradication therapy.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* 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 Criteria:

* 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).

Where it's running

• Clinical Center of Serbia - Clinic for Gastroenterohepatology
  Belgrade, Central Serbia, Serbia Recruiting
• Zvezdara Medical Center - Department of Gastroenterology
  Belgrade, Central Serbia, Serbia Recruiting

Study contacts

• Principal investigator: Dragana Mijač, MD, PhD — Clinic for Gastroenterohepatology, Clinical Center of Serbia
• Study coordinator: Dragana Mijač, MD, PhD
• Email: draganamijac@gmail.com
• Phone: +381 11 3088672

Similar studies

Other studies for the same condition or treatment. Recruiting studies are listed first.

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.