NCT06889246

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

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

• Status: Completed
• Phase: N/A
• Study type: Interventional
• Enrollment: 27 (actual)
• Sponsor: Haiphong University of Medicine and Pharmacy · Academic / Other
• Sex: All
• Age: 18 Years
• Healthy volunteers: Not accepted

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.

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.

Conditions

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

Interventions

Type	Name	Description
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.

Timeline

• Start date: 2024-08-06
• Primary completion: 2024-08-29
• Completion: 2024-12-30
• First posted: 2025-03-21
• Last updated: 2025-09-15

Locations

2 sites across 1 country: Vietnam