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

NCT06889246 | Completed DMC

• 2 other identifiers: HPMU.CTBE/P032402/2024/HD/AV-YDHP
• Study Type: interventional
• Target: 27
• Locations: 1 country
• Sites: 2

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 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.

Conditions

GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency; GERD (Heartburn, Regurgitation, and Dyspepsia) Severity

Keywords

Anvitra Gastric Suspension; GERD treatment; heartburn relief; regurgitation relief; dyspepsia relief

Outcome Measures

Primary Outcomes (1)

• GERD Condition Improvement Assessment

  Assessment of changes in GERD (heartburn, regurgitation, and dyspepsia) severity and frequency using the Reflux Disease Questionnaire (RDQ). The RDQ uses a scale ranging from 0 (Not at all) to 5 (Extremely severe). Higher scores indicate worse outcomes.

  Day 15 and Day 21

Secondary Outcomes (1)

• Adverse Events Monitoring

  Throughout the 21-Day Study Period

Study Arms (1)

Anvitra Gastric Suspension

EXPERIMENTAL

This arm includes 24 patients who receive the health supplement Anvitra Gastric Suspension. Participants take the product orally, 1 packet per dose, 30 minutes after breakfast, lunch and dinner, for 14 days.

Dietary Supplement: Anvitra Gastric Suspension

Interventions

Anvitra Gastric Suspension DIETARY_SUPPLEMENT

Anvitra Gastric Suspension is provided as a liquid oral preparation, designed with a pleasant flavor to ensure compliance in patients. The intervention involves administering 1 packet (15 ml) per dose three times daily, taken orally 30 minutes after meals, for a duration of 14 days. The supplement is intended to alleviate symptoms of GERD (heartburn, regurgitation, and dyspepsia). Anvitra Gastric Suspension has been widely used in clinical and community settings, with a favorable safety profile and reported effectiveness in GERD treament.

Anvitra Gastric Suspension

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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.

You may not qualify if:

• 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.
• \. Current use of medications that affect the gastrointestinal tract, medications that are known to cause or aggravate gastroesophageal reflux disease.
• \. Participation in another clinical study with a study intervention performed within the last 14 days.
• \. Planned hospitalization during the study.
• \. 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.
• \. Women only: currently pregnant (confirmed by a positive pregnancy test), breastfeeding or planning to become pregnant during the study, or not using acceptable contraception.

Sponsors & Collaborators

• Haiphong University of Medicine and Pharmacy: lead

Study Sites (2)

Center for Clinical Trial and Bioequivalence Study

Haiphong, Hải Phòng, Vietnam

Location

Center for Clinical Trial and Bioequivalence Study, Haiphong University of Medicine and Pharmacy

Haiphong, Vietnam

Location

MeSH Terms

Conditions

Gastroesophageal Reflux; Heartburn; Dyspepsia

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: NA
• Masking: NONE
• Purpose: SUPPORTIVE CARE
• Intervention Model: SINGLE GROUP
• Sponsor Type: OTHER
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: March 15, 2025
• First Posted: March 21, 2025
• Study Start: August 6, 2024
• Primary Completion: August 29, 2024
• Study Completion: December 30, 2024
• Last Updated: September 15, 2025

Record last verified: 2025-09

Data Sharing

• IPD Sharing: Will not share

Locations

VN (2)