The Anti-gastroesophageal Reflux Effect of Anvitra Gastric Suspension Health Supplements on Outpatients With Gastroesophageal Reflux Disease

Launched by HAIPHONG UNIVERSITY OF MEDICINE AND PHARMACY · Mar 15, 2025

Keywords

ClinConnect Summary

The study spans 22 days for each participant, consisting of three phases:

1. Screening Phase (1 day): Eligibility determined based on inclusion and exclusion criteria.
2. Treatment Phase (14 days): Daily administration of the research product.
3. Follow-Up Phase (7 days): Monitoring of post-treatment outcomes.

Visit 1 After clinical examination, patients who meet the criteria for participation in the study, with a preliminary diagnosis of gastroesophageal reflux, the participant signs the consent form, the participant is checked for vital signs, paraclinical tests, clinical examination, a...

Gender

ALL

Eligibility criteria

• Inclusion Criteria:
• • 1. Age 18 years or older at the time of signing the ICF
• • 2. Diagnosis of GERD
• • 3. Los Angeles Grade A or B esophagitis
• • 4. Symptoms of heartburn, reflux, or dyspepsia
• • 5. The participant is willing and able, in the opinion of the investigator, to modify current GERD therapy as required by the protocol.
• • 6. 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:
• • 1. 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
• • 2. History of other gastrointestinal diseases, severe diseases of other organs
• • 3. Esophagitis grade C, D according to the Los Angeles classification
• • 4. 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.
• • 6. Current use of medications that affect the gastrointestinal tract, medications that are known to cause or aggravate gastroesophageal reflux disease.
• • 7. Participation in another clinical study with a study intervention performed within the last 14 days.
• • 8. Planned hospitalization during the study.
• • 9. The investigator's judgment that the participant should not participate in the study if the participant is unable to comply with the study procedures, restrictions and requirements.
• • 10. Women only: currently pregnant (confirmed by a positive pregnancy test), breastfeeding or planning to become pregnant during the study, or not using acceptable contraception.