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 range
18 Years
Sex
ALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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
Questions worth asking your doctor
Bring these to your next appointment. They're a starting point for a shared conversation — not a sign you qualify or a recommendation to enrol.
1Based on my diagnosis and history, is this trial worth exploring for me — or is there a standard treatment we should try first?
2What does this trial's phase tell us about how much is already known about its safety and benefit?
3What would taking part actually involve for me — visits, tests, time, and travel?
4What are the known and possible risks or side effects I should weigh, and how would they be monitored?
5If this trial isn't the right fit, what other options or trials would you suggest I look into?
Generated to help you prepare — always confirm anything about your own eligibility and care with the study team and your doctor.
Questions for the trial coordinator
The trial coordinator is the person who runs the study day to day. These cover the practical side — logistics, costs, and what taking part would actually mean for your life. The study team confirms whether you meet the criteria; these are questions to ask, not a sign you qualify.
1What does taking part actually involve week to week — how many visits, where, and how long does each one take?
2What costs are covered by the study, and what might I have to pay for myself, including travel, parking, or time off work?
3What happens during screening, and what happens if the study team confirms I don't meet the criteria after those tests?
4Who pays for the scans, blood work, and other tests the trial requires — the study, my insurance, or me?
5How will being in the trial affect my regular care, and will my own doctor stay informed and involved?
6Can I leave the trial at any point if I change my mind, and what would happen to my care if I do?
A starting point for the conversation — always confirm anything about your own eligibility, costs, and care with the study team and your doctor.
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
. 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
. 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.