Status:
COMPLETED
The Anti-gastroesophageal Reflux Effect of Anvitra Gastric Suspension on Outpatients With Gastroesophageal Reflux Disease
Lead Sponsor:
Haiphong University of Medicine and Pharmacy
Conditions:
GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency
GERD (Heartburn, Regurgitation, and Dyspepsia) Severity
Eligibility:
All Genders
18+ years
Phase:
NA
Brief 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 wil...
Detailed Description
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): D...
Eligibility Criteria
Inclusion
- 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
- 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.
- 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.
Key Trial Info
Start Date :
August 6 2024
Trial Type :
INTERVENTIONAL
Allocation :
ACTUAL
End Date :
December 30 2024
Estimated Enrollment :
27 Patients enrolled
Trial Details
Trial ID
NCT06889246
Start Date
August 6 2024
End Date
December 30 2024
Last Update
September 15 2025
Active Locations (2)
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1
Center for Clinical Trial and Bioequivalence Study
Haiphong, Hải Phòng, Vietnam
2
Center for Clinical Trial and Bioequivalence Study, Haiphong University of Medicine and Pharmacy
Haiphong, Vietnam