The Anti-gastroesophageal Reflux Effect of Anvitra Gastric Suspension on Outpatients With Gastroe… (NCT06889246) | Clinical Trial Compass
CompletedNot Applicable
The Anti-gastroesophageal Reflux Effect of Anvitra Gastric Suspension on Outpatients With Gastroesophageal Reflux Disease
Vietnam27 participantsStarted 2024-08-06
Plain-language summary
This is an open-label, single-center clinical trial evaluating the efficacy and safety of Anvitra Gastric Suspension health supplements in adult patients with gastroesophageal reflux. Participants will be given Anvitra for 14 consecutive days and will continue to be monitored for 7 days after the intervention. The study aims to assess improvements in GERD (gastroesophageal reflux disease) symtoms, as well as monitor adverse events associated with the interventions. Data will be collected over a 22-day period, including screening, treatment, and follow-up phases.
Who can participate
Age range18 Years
SexALL
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Inclusion criteria
✓. Age 18 years or older at the time of signing the ICF
✓. Diagnosis of GERD
✓. Los Angeles Grade A or B esophagitis
✓. Symptoms of heartburn, reflux, or dyspepsia
✓. The participant is willing and able, in the opinion of the investigator, to modify current GERD therapy as required by the protocol.
✓. Ability to sign an informed consent form for participation in the study as described in Appendix A, including compliance with the requirements and restrictions listed in the ICF and in this protocol.
Exclusion criteria
✕. Concomitant esophageal stenosis, tumors, esophageal cancer, Barrett's esophagus, stomach cancer, gastric ulcer: confirmed by the results of esophagogastroduodenoscopy at the first examination and/or medical records
✕. History of other gastrointestinal diseases, severe diseases of other organs
✕. Esophagitis grade C, D according to the Los Angeles classification
What they're measuring
1
GERD Condition Improvement Assessment
Timeframe: Day 15 and Day 21
Trial details
NCT IDNCT06889246
SponsorHaiphong University of Medicine and Pharmacy
✕. Unable to perform esophagogastroduodenoscopy: esophageal diseases that can cause esophageal perforation (esophageal burns due to chemicals, drugs causing esophageal stenosis), thoracic aortic aneurysm, heart failure, myocardial infarction, hypertensive crisis, respiratory failure, difficulty breathing due to any cause, severe cough, severe scoliosis, elderly patients, mentally ill patients who cannot cooperate, hypotension, patients who do not agree to perform. 5. Severe hepatic or renal impairment and other chronic medical conditions.