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

Open-label, Single-center Clinical Trial to Evaluate the Anti-gastroesophageal Reflux Effect of Anvitra Gastric Suspension Health Supplements on Outpatients With Gastroesophageal Reflux at Hai Phong Medical University Hospital in 2024

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.

Study Overview

• Status: Completed
• Conditions: GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency; GERD (Heartburn, Regurgitation, and Dyspepsia) Severity
• Intervention / Treatment: Dietary supplement: Anvitra Gastric Suspension

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): 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, and answers to the reflux disease questionnaire (RDQ). The study accepts the results of previous esophagogastric endoscopy within 28 days. The results of the endoscopy will be used to exclude other diseases of the digestive tract according to the exclusion criteria. The participant will be instructed to stop all drugs or any products that have the effect of reducing gastric acid secretion, anti-reflux and drugs that can aggravate reflux. At the end of Visit 1, participants will be provided with Anvitra Gastric Suspension for approximately 14 days until Visit 2. Participants will be instructed and self-administered Anvitra Gastric Suspension for the first time under the supervision of study site staff at Visit 1.

The investigator will contact daily to check the product usage history, remind participants to use the product and record any AEs/SAEs by using RDQ to assess the change in severity of symptoms each day.

Visit 2 On the morning of Day D15, all participants must carefully record the time of the last study intervention (evening of Day D14). Participants will be checked for vital signs, paraclinical tests, clinical examination, and answer the RDQ.

A telephone follow-up will occur approximately 7 days after (day D21) the last treatment dose to continue recording of AEs/SAEs.

• Study Type: Interventional
• Enrollment (Actual): 27
• Phase: Not Applicable

Contacts and Locations

Study Locations

• Vietnam
  • Haiphong, Vietnam
    • Center for Clinical Trial and Bioequivalence Study, Haiphong University of Medicine and Pharmacy
  • Hải Phòng
    • Haiphong, Hải Phòng, Vietnam
      • Center for Clinical Trial and Bioequivalence Study

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

Description

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.

Study Plan

How is the study designed?

Design Details

• Primary Purpose: Supportive Care
• Allocation: N/A
• Interventional Model: Single Group Assignment
• Masking: None (Open Label)

Number of Arms

1

Arms and Interventions

Participant Group / Arm

Intervention / Treatment

Experimental: Anvitra Gastric Suspension; 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; 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.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	Measure Description	Time Frame
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 Outcome Measures

Outcome Measure	Measure Description	Time Frame
Adverse Events Monitoring	Monitoring and recording of adverse events associated with Anvitra Gastric Suspension throughout the study period	Throughout the 21-Day Study Period

Collaborators and Investigators

• Sponsor: Haiphong University of Medicine and Pharmacy

Study record dates

Study Major Dates

• Study Start (Actual): August 6, 2024
• Primary Completion (Actual): August 29, 2024
• Study Completion (Actual): December 30, 2024

Study Registration Dates

• First Submitted: March 15, 2025
• First Submitted That Met QC Criteria: March 15, 2025
• First Posted (Actual): March 21, 2025

Study Record Updates

• Last Update Posted (Estimated): September 15, 2025
• Last Update Submitted That Met QC Criteria: September 8, 2025
• Last Verified: September 1, 2025

More Information

Terms related to this study

• Keywords: GERD treatment; Anvitra Gastric Suspension; heartburn relief; regurgitation relief; dyspepsia relief
• Additional Relevant MeSH Terms: Signs and Symptoms, Digestive; Digestive System Diseases; Gastrointestinal Diseases; Esophageal Diseases; Esophageal Motility Disorders; Deglutition Disorders; Pathological Conditions, Signs and Symptoms; Signs and Symptoms; Gastroesophageal Reflux; Dyspepsia; Heartburn
• Other Study ID Numbers: HPMU.CTBE/P0324; 02/2024/HD/AV-YDHP (Other Grant/Funding Number: Anvy Joint Stock Company)

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: As the request of the sponsor

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No
• product manufactured in and exported from the U.S.: No