GERD (Heartburn, Regurgitation, and Dyspepsia) FrequencyANVITRANCT06889246
The Anti-gastroesophageal Reflux Effect of Anvitra Gastric Suspension on Outpatients With Gastroesophageal Reflux Disease
A study testing Anvitra Gastric Suspension in people with GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency and GERD (Heartburn, Regurgitation, and Dyspepsia) Severity, run by Haiphong University of Medicine and Pharmacy at 2 sites in Vietnam.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 years and older
- Conditions the study is for
- GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency, GERD (Heartburn, Regurgitation, and Dyspepsia) Severity
- What is being tested?
- Anvitra Gastric Suspension
- Type of treatment
- Pill or oral medicine
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 27 participants
- Where
- 2 sitesVietnam
- Study dates
- 6 Aug 2024to 30 Dec 2024
- Phase
- Interventional
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 years and older
- All sexes
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- 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.
Who cannot join
- 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.
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- 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.
Trial locations and contacts
2 sites in 1 country.
Vietnam2 sites
Center for Clinical Trial and Bioequivalence Study
Haiphong, Hải Phòng
Center for Clinical Trial and Bioequivalence Study, Haiphong University of Medicine and Pharmacy
Haiphong
About this study
Official title: 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.
Read the detailed description
The study spans 22 days for each participant, consisting of three phases:
- Screening Phase (1 day): Eligibility determined based on inclusion and exclusion criteria.
- Treatment Phase (14 days): Daily administration of the research product.
- 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
- Being tested
- Anvitra Gastric Suspension
- Keywords
- Anvitra Gastric Suspension, GERD treatment, heartburn relief, regurgitation relief, dyspepsia relief
- Medical subject headings
- Gastroesophageal Reflux, Heartburn, Dyspepsia
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Anvitra Gastric SuspensionDietary 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.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Dietary Supplement: Anvitra Gastric Suspension |
What is being measured
The primary outcome is the main question the study is designed to answer.
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.
Measured: Day 15 and Day 21
Secondary outcomes (1)
Adverse Events Monitoring
Monitoring and recording of adverse events associated with Anvitra Gastric Suspension throughout the study period
Measured: Throughout the 21-Day Study Period
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Mar 2025
- Study start6 Aug 2024
- Primary completion29 Aug 2024
- Study completion30 Dec 2024
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for GERD (Heartburn, Regurgitation, and Dyspepsia) FrequencyStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 27 participants (actual)
Sponsor and investigators
- Lead sponsor
- Haiphong University of Medicine and Pharmacy
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06889246
- Sponsor's protocol ID
- HPMU.CTBE/P0324
- Other IDs
- 02/2024/HD/AV-YDHP
- Acronym
- ANVITRA
- Status last verified
- Sep 2025
- First submitted
- 15 Mar 2025
- Last updated
- 15 Sep 2025
- Results posted
- No
- Data monitoring committee
- Yes
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: As the request of the sponsor
Study at a glance
From the registry record, last updated by the sponsor on 15 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- 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
- ClinicalTrials.gov ID
- NCT06889246
- Acronym / sponsor ID
- ANVITRA / HPMU.CTBE/P0324
- 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
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 27 participants (actual)
- Lead sponsor
- Haiphong University of Medicine and PharmacyUniversity, hospital or other
- Study start
- 6 Aug 2024 (actual)
- Primary completion
- 29 Aug 2024 (actual)
- Study completion
- 30 Dec 2024 (actual)
- First posted
- 21 Mar 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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:
- Screening Phase (1 day): Eligibility determined based on inclusion and exclusion criteria.
- Treatment Phase (14 days): Daily administration of the research product.
- 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 design
- Primary purpose
- Supportive care
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Anvitra Gastric Suspension | Experimental | Dietary Supplement: Anvitra Gastric SuspensionThis 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. |
Who may qualify
- Ages
- 18 years and older
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (6 listed)
- 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.
Key exclusion criteria (9 listed)
- 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.
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Anvitra Gastric SuspensionAnvitra 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. | Dietary supplement | Anvitra Gastric Suspension |
Primary outcome
GERD Condition Improvement Assessment
Time frame: Day 15 and Day 21
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.
1 secondary outcome
Adverse Events Monitoring
Time frame: Throughout the 21-Day Study Period
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 15 Sep 2025.
- Individual participant dataSharing planned: No. As the request of the sponsor
Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
The record lists no contact. Use the official record to reach the sponsor.
2 sites in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing Anvitra Gastric Suspension in people with GERD (Heartburn, Regurgitation, and Dyspepsia) Frequency and GERD (Heartburn, Regurgitation, and Dyspepsia) Severity, run by Haiphong University of Medicine and Pharmacy at 2 sites in Vietnam.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 6 inclusion and 9 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 15 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 2 sites in Vietnam. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
GERD Condition Improvement Assessment (time frame: Day 15 and Day 21). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 15 Sep 2025.