An interventional study of Anvitra Gastric Suspension in GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency and GERD (Heartburn, Regurgitation, and Dyspepsia) Severity, sponsored by Haiphong University of Medicine and Pharmacy. Completed at 2 sites in Vietnam. Open to participants aged 18 Years and older. Per ClinicalTrials.gov, last updated 2025-09-15.
Sponsored by Haiphong University of Medicine and Pharmacy · Not applicable, Interventional, and Supportive care
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.
The study spans 22 days for each participant, consisting of three phases:
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 27 is below the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →Haiphong University of Medicine and Pharmacy is the lead sponsor of 10 studies on the registry; 6 are open to participants now.
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Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
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 .
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraception
Ways of preventing pregnancy. “Highly effective” methods fail less than 1% of the time a year when used correctly — for example an IUD or an implant.
Criteria usually say which methods count and how long to keep using them after the last dose, sometimes for male participants too. Some studies accept a partner’s vasectomy if it was confirmed successful and that person is the participant’s only sexual partner.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
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.
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.
Time frame: Day 15 and Day 21
Adverse Events Monitoring
Monitoring and recording of adverse events associated with Anvitra Gastric Suspension throughout the study period
Time frame: Throughout the 21-Day Study Period
Plan to share: No — As the request of the sponsor
No publications or documents are linked to this record.
This study is completed, as verified in Sep 2025. You cannot join it, but the record below documents what was studied.
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Haiphong University of Medicine and Pharmacy