Gastroesophageal Reflux Disease (GERD)NCT07910656
PDO Thread Embedding Plus Binh Vi Tablets for Gastroesophageal Reflux Disease
A study testing PDO Thread Embedding, Esomeprazole 40 mg Oral Tablet and Binh Vi Tablets in people with Gastroesophageal Reflux Disease (GERD), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site in Vietnam.
Trial summary
The goal of this clinical trial is to learn if PDO thread embedding combined with Binh Vi tablets and Esomeprazole works better than Binh Vi tablets and Esomeprazole alone in treating gastroesophageal reflux disease (GERD) in adults. Read more about this study
- Who is it for?
- Ages 18 to 60 years
- Conditions the study is for
- Gastroesophageal Reflux Disease (GERD)
- What is being tested?
- PDO Thread Embedding, Esomeprazole 40 mg Oral Tablet and Binh Vi Tablets
- Type of treatment
- Pill or oral medicine, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 86 participants
- Where
- 1 siteVietnam
- Study dates
- 20 Mar 2026to 31 Aug 2026
- 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 to 60 years
- All sexes
- No healthy volunteers
- Adult
Who may be able to join
- Adults aged 18 to under 60 years presenting for examination and treatment at Ho Chi Minh City Traditional Medicine Hospital, regardless of sex or occupation.
- Diagnosis of gastroesophageal reflux disease (GERD), defined as a GerdQ score of 8 or higher, with heartburn and/or regurgitation occurring at least 2 days per week, and an indication for standard-dose proton pump inhibitor (PPI) therapy according to the 2022 American College of Gastroenterology (ACG) and 2017 World Gastroenterology Organisation (WGO) guidelines.
- Not currently receiving treatment for GERD.
- Willingness to participate in the study and comply with the treatment regimen.
Who cannot join
- Known inflammatory bowel disease; serious hepatic, renal, respiratory, or cardiovascular disease; serious comorbid conditions; rare hereditary disorders (including fructose intolerance, glucose-galactose malabsorption, or congenital sucrase-isomaltase deficiency); or a history of drug or alcohol abuse.
- Clinical alarm symptoms, including dysphagia, odynophagia, recurrent bronchial symptoms, aspiration pneumonia, dyspnea, recurrent or persistent cough, gastrointestinal bleeding, frequent nausea and/or vomiting, persistent pain, ongoing unintentional weight loss, lymphadenopathy, an epigastric mass, newly developed atypical symptoms between ages 45 and 55, or a family history of carcinoma of the esophagus or stomach.
- History of esophageal and/or gastrointestinal surgery.
- Current use of medications that may interfere with GERD treatment or assessment, including systemic glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), calcium channel blockers, anticholinergics, bisphosphonates, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, tetracyclines, HIV protease inhibitors, rifampin, potassium supplements, iron, quinidine, zidovudine, alpha-adrenergic agents, beta-2 adrenergic agonists, benzodiazepines, barbiturates, dopamine, estrogens, progesterone, opioid analgesics, nitrates, prostaglandins, or theophylline.
- Use of GERD medication within the specified washout periods before screening: PPIs within 14 days; histamine-2 receptor antagonists or prokinetics within 10 days; alginate-containing medications or antacids within 3 days; or herbal medicines for GERD at least 2 days per week.
- Receipt of traditional medicine treatment for GERD within 14 days before screening.
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- Any contraindication to acupoint thread embedding according to the 2013 Vietnamese Ministry of Health guidance, including an acute medical emergency, severe physical debilitation, reduced resistance, pregnancy, infection or skin disease at the acupoint sites, or allergy to absorbable sutures or acupuncture needles.
- History of adverse reactions to proton pump inhibitors (PPIs), including reactions to formulation excipients.
- Current use of anticoagulants or a coagulation disorder due to another medical condition.
- Current participation in another interventional study.
- Psychiatric illness or dementia.
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Evaluation of the Effectiveness of PDO Thread Embedding Combined With Binh Vi Tablets in the Treatment of Gastroesophageal Reflux Disease (GERD)
The goal of this clinical trial is to learn if PDO thread embedding combined with Binh Vi tablets and Esomeprazole works better than Binh Vi tablets and Esomeprazole alone in treating gastroesophageal reflux disease (GERD) in adults.
The main questions it aims to answer are:
Read more
- Does adding PDO thread embedding improve GERD symptoms more effectively?
- Does the combined treatment improve participants' quality of life?
- What adverse effects may occur during PDO thread embedding? Researchers will compare PDO thread embedding combined with Esomeprazole 40 mg and Binh Vi tablets to Esomeprazole 40 mg and Binh Vi tablets alone to evaluate symptom improvement, clinical response, quality of life, and safety.
Participants will:
- Be randomly assigned to receive either PDO thread embedding plus Esomeprazole 40 mg and Binh Vi tablets, or Esomeprazole 40 mg and Binh Vi tablets alone.
- Receive treatment for 4 weeks. Participants in the PDO thread embedding group will receive 2 sessions, one every 2 weeks.
- Visit the clinic for treatment and checkups.
- Complete questionnaires about GERD symptoms and quality of life at the start of the study, at 2 weeks, and at 4 weeks.
Read the detailed description
Study Population:
Adults aged 18 to under 60 years diagnosed with gastroesophageal reflux disease (GERD) who meet the study's eligibility criteria will be randomly assigned to one of two groups.
Group 1 (Control):
Esomeprazole 40 mg + Binh Vi tablets. Treatment period: 4 weeks.
Group 2 (Intervention):
PDO thread embedding + Esomeprazole 40 mg + Binh Vi tablets.
PDO thread embedding procedure:
Two sessions over 4 weeks, once every 2 weeks. A total of 12 PDO threads will be inserted at 12 locations during each session. Acupoints: Bilateral Pishu (BL20), Weishu (BL21), Neiguan (PC6), Zusanli (ST36), and Fenglong (ST40), plus Zhongwan (CV12) and Danzhong (CV17).
Evaluation:
Assessment time points: baseline (T0), week 2 (T2), and week 4 (T4). Primary outcome: Change in the total Gastroesophageal Reflux Disease Questionnaire (GerdQ) score.
Secondary outcomes: GERD symptom scores, clinical response according to Traditional Medicine criteria, and health-related quality of life measured using the EQ-5D-5L questionnaire.
Safety: Monitoring of adverse events associated with PDO thread embedding during the 4-week study period.
Study site: Ho Chi Minh City Traditional Medicine Hospital, Vietnam. Study period: March 20, 2026, to August 31, 2026.
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Being tested
- PDO Thread Embedding, Esomeprazole 40 mg Oral Tablet, Binh Vi Tablets
- Keywords
- GERD, Gastroesophageal Reflux Disease, PDO Thread Embedding, Binh Vi Tablets, Traditional Medicine, GerdQ, EQ-5D-5L
- Medical subject headings
- Gastroesophageal Reflux
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
PDO Thread EmbeddingProcedure or surgery
PDO thread embedding is performed twice over 4 weeks, at baseline (T0) and week 2 (T2), with 12 PDO threads per session. Acupoints: bilateral Pishu (BL20), Weishu (BL21), Neiguan (PC6), Zusanli (ST36), and Fenglong (ST40), plus Zhongwan (CV12) and Danzhong (CV17) on the midline. Needle-thread sizes: 31G-30 mm (7.0-30 mm thread) or 29G-40 mm (6.0-50 mm thread), selected according to tissue thickness.
Esomeprazole 40 mg Oral TabletDrug
Esomeprazole 20 mg tablets manufactured by STADA Vietnam. Dose: 40 mg (two 20 mg tablets) orally once daily, 30 minutes before breakfast, for 28 consecutive days. Administered in both study groups.
Binh Vi TabletsDrug
Binh Vi tablets manufactured by Ho Chi Minh City Traditional Medicine Hospital, Vietnam. Dose: 10 tablets orally twice daily for 28 consecutive days. Administered in both study groups.
| Study group | Role | What they receive |
|---|---|---|
| PDO Thread Embedding + Esomeprazole 40 mg + Binh Vi Tablets | Experimental | Participants receive PDO thread embedding twice over 4 weeks, once every 2 weeks, in addition to Esomeprazole 40 mg and Binh Vi tablets. Receives: Procedure: PDO Thread Embedding; Drug: Esomeprazole 40 mg Oral Tablet; Drug: Binh Vi Tablets |
| Esomeprazole 40 mg + Binh Vi Tablets | Active comparator | Participants receive Esomeprazole 40 mg and Binh Vi tablets alone for 4 weeks, without PDO thread embedding. Receives: Drug: Esomeprazole 40 mg Oral Tablet; Drug: Binh Vi Tablets |
What is being measured
The primary outcome is the main question the study is designed to answer.
Change in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score From Baseline to Week 4
The GerdQ is a validated questionnaire used to assess the frequency of gastroesophageal reflux disease symptoms and their impact. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms. The change in total GerdQ score from baseline to week 4 will be compared between the two study groups.
Measured: Baseline (T0) to week 4 (T4)
Secondary outcomes (4)
Change in GerdQ Score From Baseline to Week 2
The change in total GerdQ score from baseline to week 2 will be used to assess the short-term change in gastroesophageal reflux disease symptoms in both study groups.
Measured: Baseline (T0) to week 2 (T2)
Clinical Response According to Traditional Medicine Criteria
Clinical response will be evaluated according to the traditional medicine criteria specified in the study protocol and compared between the two study groups.
Measured: Baseline (T0) to week 4 (T4)
Change in EQ-5D-5L Quality-of-Life Scores From Baseline to Week 4
Health-related quality of life will be assessed using the EQ-5D-5L questionnaire. Changes in the EQ-5D-5L scores from baseline to week 4 will be compared between the two study groups.
Measured: Baseline (T0) to week 4 (T4)
Incidence of Adverse Events
The number and proportion of participants experiencing adverse events during the study will be recorded and compared between the two study groups. Adverse events associated with PDO thread embedding and other study interventions will be documented.
Measured: From baseline (T0) through week 4 (T4)
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted2 Nov 2026
- Study start20 Mar 2026
- Primary completion31 Aug 2026
- Study completion31 Aug 2026
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Publications (11)Papers the sponsor has linked to this study.
- Other trials for Gastroesophageal Reflux Disease (GERD)Studies of the same condition, open and under way.
- More trials run by University of Medicine and Pharmacy at Ho Chi Minh CityThe sponsor's other registered studies.
- 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
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Model description
- Participants were randomly assigned to one of two parallel groups. The intervention group received PDO thread embedding plus Esomeprazole 40 mg and Binh Vi tablets. The control group received Esomeprazole 40 mg and Binh Vi tablets alone. Both groups received treatment for 4 weeks.
- Masking
- Single blind
- Who is masked
- Outcomes assessor
- Enrolment
- 86 participants (actual)
Sponsor and investigators
- Sponsor type
- University, hospital or other
- Collaborators
- Traditional Medicine Hospital of Ho Chi Minh City
- Responsible party
- Principal investigator, Bui Tien Thanh, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigators
- Thanh Tien Bui, MSc, MD, Principal investigator, Ho Chi Minh City Traditional Medicine Hospital
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT07910656
- Sponsor's protocol ID
- 26118-DHYD
- Other IDs
- 1350/DHYD-HDĐĐ
- Status last verified
- Oct 2026
- First submitted
- 27 Oct 2026
- Last updated
- 2 Nov 2026
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: Individual participant data (IPD) will not be shared outside the research team in order to protect participant confidentiality and privacy.
Publications
Min YW, Lim SW, Lee JH, Lee HL, Lee OY, Park JM, Choi MG, Rhee PL. Prevalence of Extraesophageal Symptoms in Patients With Gastroesophageal Reflux Disease: A Multicenter Questionnaire-based Study in Korea. J Neurogastroenterol Motil. 2014 Jan;20(1):87-93. doi: 10.5056/jnm.2014.20.1.87. Epub 2013 Dec 30.
PubMed 24466449Cheng Y, Kou F, Liu J, Dai Y, Li X, Li J. Systematic assessment of environmental factors for gastroesophageal reflux disease: An umbrella review of systematic reviews and meta-analyses. Dig Liver Dis. 2021 May;53(5):566-573. doi: 10.1016/j.dld.2020.11.022. Epub 2020 Dec 16.
PubMed 33339748Zamani M, Alizadeh-Tabari S, Hasanpour AH, Eusebi LH, Ford AC. Systematic review with meta-analysis: association of Helicobacter pylori infection with gastro-oesophageal reflux and its complications. Aliment Pharmacol Ther. 2021 Oct;54(8):988-998. doi: 10.1111/apt.16585. Epub 2021 Aug 26.
PubMed 34437710Garcia-Gonzales DA, Shonkoff SBC, Hays J, Jerrett M. Hazardous Air Pollutants Associated with Upstream Oil and Natural Gas Development: A Critical Synthesis of Current Peer-Reviewed Literature. Annu Rev Public Health. 2019 Apr 1;40:283-304. doi: 10.1146/annurev-publhealth-040218-043715.
PubMed 30935307Kazemi AH, Adel-Mehraban MS, Jamali Dastjerdi M, Alipour R. A comprehensive practical review of acupoint embedding as a semi-permanent acupuncture: A mini review. Medicine (Baltimore). 2024 Jun 7;103(23):e38314. doi: 10.1097/MD.0000000000038314.
PubMed 38847703Luo Z, Hu X, Chen C, Zhu L, Zhang W, Shen Y, He J. Effect of Catgut Embedment in Du Meridian Acupoint on Mental and Psychological Conditions of Patients with Gastroesophageal Reflux Disease. Evid Based Complement Alternat Med. 2020 Sep 22;2020:5415813. doi: 10.1155/2020/5415813. eCollection 2020.
PubMed 33029166YIN, J., PENG, Z., SHI, L., CHEN, C., CHEN, Y., & LI, G. Visual analysis of related researches in the treatment of gastroesophageal reflux disease with traditional Chinese medicine based on Citespace. Journal of Clinical Medicine in Practice, 26(22), 65-71.
Goh KL, Lee YY, Leelakusolvong S, Makmun D, Maneerattanaporn M, Quach DT, Raja Ali RA, Sollano JD, Tran VH, Wong RK. Consensus statements and recommendations on the management of mild-to-moderate gastroesophageal reflux disease in the Southeast Asian region. JGH Open. 2021 Jul 31;5(8):855-863. doi: 10.1002/jgh3.12602. eCollection 2021 Aug.
PubMed 34386592Xiao J, Yang Y, Zhu Y, Qin Y, Li Y, Fu M, Zhai Z, Zhu L. Efficacy and Safety of Traditional Chinese Medicine on Nonerosive Reflux Disease: A Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2018 May 24;2018:1505394. doi: 10.1155/2018/1505394. eCollection 2018.
PubMed 29977310Nirwan JS, Hasan SS, Babar ZU, Conway BR, Ghori MU. Global Prevalence and Risk Factors of Gastro-oesophageal Reflux Disease (GORD): Systematic Review with Meta-analysis. Sci Rep. 2020 Apr 2;10(1):5814. doi: 10.1038/s41598-020-62795-1.
PubMed 32242117Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018 Mar;67(3):430-440. doi: 10.1136/gutjnl-2016-313589. Epub 2017 Feb 23.
PubMed 28232473
Study at a glance
From the registry record, last updated by the sponsor on 2 Nov 2026. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Evaluation of the Effectiveness of PDO Thread Embedding Combined With Binh Vi Tablets in the Treatment of Gastroesophageal Reflux Disease (GERD)
- ClinicalTrials.gov ID
- NCT07910656
- Acronym / sponsor ID
- 26118-DHYD
- Conditions
- Gastroesophageal Reflux Disease (GERD)
- Keywords
- GERD, Gastroesophageal Reflux Disease, PDO Thread Embedding, Binh Vi Tablets, Traditional Medicine, GerdQ, EQ-5D-5L
- Study type
- Interventional
- Recruitment status
- Completed
- Enrolment
- 86 participants (actual)
- Lead sponsor
- University of Medicine and Pharmacy at Ho Chi Minh CityUniversity, hospital or other
- Collaborators
- Traditional Medicine Hospital of Ho Chi Minh City
- Study start
- 20 Mar 2026 (actual)
- Primary completion
- 31 Aug 2026 (actual)
- Study completion
- 31 Aug 2026 (actual)
- First posted
- 2 Nov 2026 (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.
The goal of this clinical trial is to learn if PDO thread embedding combined with Binh Vi tablets and Esomeprazole works better than Binh Vi tablets and Esomeprazole alone in treating gastroesophageal reflux disease (GERD) in adults.
The main questions it aims to answer are:
- Does adding PDO thread embedding improve GERD symptoms more effectively?
- Does the combined treatment improve participants' quality of life?
- What adverse effects may occur during PDO thread embedding? Researchers will compare PDO thread embedding combined with Esomeprazole 40 mg and Binh Vi tablets to Esomeprazole 40 mg and Binh Vi tablets alone to evaluate symptom improvement, clinical response, quality of life, and safety.
Participants will:
- Be randomly assigned to receive either PDO thread embedding plus Esomeprazole 40 mg and Binh Vi tablets, or Esomeprazole 40 mg and Binh Vi tablets alone.
- Receive treatment for 4 weeks. Participants in the PDO thread embedding group will receive 2 sessions, one every 2 weeks.
- Visit the clinic for treatment and checkups.
- Complete questionnaires about GERD symptoms and quality of life at the start of the study, at 2 weeks, and at 4 weeks.
Detailed description
Study Population:
Adults aged 18 to under 60 years diagnosed with gastroesophageal reflux disease (GERD) who meet the study's eligibility criteria will be randomly assigned to one of two groups.
Group 1 (Control):
Esomeprazole 40 mg + Binh Vi tablets. Treatment period: 4 weeks.
Group 2 (Intervention):
PDO thread embedding + Esomeprazole 40 mg + Binh Vi tablets.
PDO thread embedding procedure:
Two sessions over 4 weeks, once every 2 weeks. A total of 12 PDO threads will be inserted at 12 locations during each session. Acupoints: Bilateral Pishu (BL20), Weishu (BL21), Neiguan (PC6), Zusanli (ST36), and Fenglong (ST40), plus Zhongwan (CV12) and Danzhong (CV17).
Evaluation:
Assessment time points: baseline (T0), week 2 (T2), and week 4 (T4). Primary outcome: Change in the total Gastroesophageal Reflux Disease Questionnaire (GerdQ) score.
Secondary outcomes: GERD symptom scores, clinical response according to Traditional Medicine criteria, and health-related quality of life measured using the EQ-5D-5L questionnaire.
Safety: Monitoring of adverse events associated with PDO thread embedding during the 4-week study period.
Study site: Ho Chi Minh City Traditional Medicine Hospital, Vietnam. Study period: March 20, 2026, to August 31, 2026.
Study design
- Primary purpose
- Treatment
- Allocation
- Randomised
- Intervention model
- Parallel groups
- Masking
- Single blind (outcomes assessor)
- Number of arms
- 2
- Model description
- Participants were randomly assigned to one of two parallel groups. The intervention group received PDO thread embedding plus Esomeprazole 40 mg and Binh Vi tablets. The control group received Esomeprazole 40 mg and Binh Vi tablets alone. Both groups received treatment for 4 weeks.
| Arm | Type | Receives |
|---|---|---|
| PDO Thread Embedding + Esomeprazole 40 mg + Binh Vi Tablets | Experimental | Procedure: PDO Thread Embedding, Drug: Esomeprazole 40 mg Oral Tablet, Drug: Binh Vi TabletsParticipants receive PDO thread embedding twice over 4 weeks, once every 2 weeks, in addition to Esomeprazole 40 mg and Binh Vi tablets. |
| Esomeprazole 40 mg + Binh Vi Tablets | Active comparator | Drug: Esomeprazole 40 mg Oral Tablet, Drug: Binh Vi TabletsParticipants receive Esomeprazole 40 mg and Binh Vi tablets alone for 4 weeks, without PDO thread embedding. |
Who may qualify
- Ages
- 18 to 60 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult
Key inclusion criteria (4 listed)
- Adults aged 18 to under 60 years presenting for examination and treatment at Ho Chi Minh City Traditional Medicine Hospital, regardless of sex or occupation.
- Diagnosis of gastroesophageal reflux disease (GERD), defined as a GerdQ score of 8 or higher, with heartburn and/or regurgitation occurring at least 2 days per week, and an indication for standard-dose proton pump inhibitor (PPI) therapy according to the 2022 American College of Gastroenterology (ACG) and 2017 World Gastroenterology Organisation (WGO) guidelines.
- Not currently receiving treatment for GERD.
- Willingness to participate in the study and comply with the treatment regimen.
Key exclusion criteria (11 listed)
- Known inflammatory bowel disease; serious hepatic, renal, respiratory, or cardiovascular disease; serious comorbid conditions; rare hereditary disorders (including fructose intolerance, glucose-galactose malabsorption, or congenital sucrase-isomaltase deficiency); or a history of drug or alcohol abuse.
- Clinical alarm symptoms, including dysphagia, odynophagia, recurrent bronchial symptoms, aspiration pneumonia, dyspnea, recurrent or persistent cough, gastrointestinal bleeding, frequent nausea and/or vomiting, persistent pain, ongoing unintentional weight loss, lymphadenopathy, an epigastric mass, newly developed atypical symptoms between ages 45 and 55, or a family history of carcinoma of the esophagus or stomach.
- History of esophageal and/or gastrointestinal surgery.
- Current use of medications that may interfere with GERD treatment or assessment, including systemic glucocorticoids, nonsteroidal anti-inflammatory drugs (NSAIDs), calcium channel blockers, anticholinergics, bisphosphonates, ketoconazole, itraconazole, voriconazole, clarithromycin, telithromycin, tetracyclines, HIV protease inhibitors, rifampin, potassium supplements, iron, quinidine, zidovudine, alpha-adrenergic agents, beta-2 adrenergic agonists, benzodiazepines, barbiturates, dopamine, estrogens, progesterone, opioid analgesics, nitrates, prostaglandins, or theophylline.
- Use of GERD medication within the specified washout periods before screening: PPIs within 14 days; histamine-2 receptor antagonists or prokinetics within 10 days; alginate-containing medications or antacids within 3 days; or herbal medicines for GERD at least 2 days per week.
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 |
|---|---|---|
| PDO Thread EmbeddingPDO thread embedding is performed twice over 4 weeks, at baseline (T0) and week 2 (T2), with 12 PDO threads per session. Acupoints: bilateral Pishu (BL20), Weishu (BL21), Neiguan (PC6), Zusanli (ST36), and Fenglong (ST40), plus Zhongwan (CV12) and Danzhong (CV17) on the midline. Needle-thread sizes: 31G-30 mm (7.0-30 mm thread) or 29G-40 mm (6.0-50 mm thread), selected according to tissue thickness. | Procedure or surgery | PDO Thread Embedding + Esomeprazole 40 mg + Binh Vi Tablets |
| Esomeprazole 40 mg Oral TabletEsomeprazole 20 mg tablets manufactured by STADA Vietnam. Dose: 40 mg (two 20 mg tablets) orally once daily, 30 minutes before breakfast, for 28 consecutive days. Administered in both study groups. | Drug | Esomeprazole 40 mg + Binh Vi Tablets, PDO Thread Embedding + Esomeprazole 40 mg + Binh Vi Tablets |
| Binh Vi TabletsBinh Vi tablets manufactured by Ho Chi Minh City Traditional Medicine Hospital, Vietnam. Dose: 10 tablets orally twice daily for 28 consecutive days. Administered in both study groups. | Drug | Esomeprazole 40 mg + Binh Vi Tablets, PDO Thread Embedding + Esomeprazole 40 mg + Binh Vi Tablets |
Primary outcome
Change in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score From Baseline to Week 4
Time frame: Baseline (T0) to week 4 (T4)
The GerdQ is a validated questionnaire used to assess the frequency of gastroesophageal reflux disease symptoms and their impact. The total score ranges from 0 to 18, with higher scores indicating more severe symptoms. The change in total GerdQ score from baseline to week 4 will be compared between the two study groups.
4 secondary outcomes
Change in GerdQ Score From Baseline to Week 2
Time frame: Baseline (T0) to week 2 (T2)
Clinical Response According to Traditional Medicine Criteria
Time frame: Baseline (T0) to week 4 (T4)
Change in EQ-5D-5L Quality-of-Life Scores From Baseline to Week 4
Time frame: Baseline (T0) to week 4 (T4)
Incidence of Adverse Events
Time frame: From baseline (T0) through week 4 (T4)
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 2 Nov 2026.
- Background: PubMed 24466449Min YW, Lim SW, Lee JH, Lee HL, Lee OY, Park JM, Choi MG, Rhee PL. Prevalence of Extraesophageal Symptoms in Patients With Gastroesophageal Reflux Disease: A Multicenter Questionnaire-based Study in Korea. J Neurogastroenterol Motil. 2014 Jan;20(1):87-93. doi: 10.5056/jnm.2014.20.1.87. Epub 2013 Dec 30.
- Background: PubMed 33339748Cheng Y, Kou F, Liu J, Dai Y, Li X, Li J. Systematic assessment of environmental factors for gastroesophageal reflux disease: An umbrella review of systematic reviews and meta-analyses. Dig Liver Dis. 2021 May;53(5):566-573. doi: 10.1016/j.dld.2020.11.022. Epub 2020 Dec 16.
- Background: PubMed 34437710Zamani M, Alizadeh-Tabari S, Hasanpour AH, Eusebi LH, Ford AC. Systematic review with meta-analysis: association of Helicobacter pylori infection with gastro-oesophageal reflux and its complications. Aliment Pharmacol Ther. 2021 Oct;54(8):988-998. doi: 10.1111/apt.16585. Epub 2021 Aug 26.
- Background: PubMed 30935307Garcia-Gonzales DA, Shonkoff SBC, Hays J, Jerrett M. Hazardous Air Pollutants Associated with Upstream Oil and Natural Gas Development: A Critical Synthesis of Current Peer-Reviewed Literature. Annu Rev Public Health. 2019 Apr 1;40:283-304. doi: 10.1146/annurev-publhealth-040218-043715.
- Background: PubMed 38847703Kazemi AH, Adel-Mehraban MS, Jamali Dastjerdi M, Alipour R. A comprehensive practical review of acupoint embedding as a semi-permanent acupuncture: A mini review. Medicine (Baltimore). 2024 Jun 7;103(23):e38314. doi: 10.1097/MD.0000000000038314.
- Background: PubMed 33029166Luo Z, Hu X, Chen C, Zhu L, Zhang W, Shen Y, He J. Effect of Catgut Embedment in Du Meridian Acupoint on Mental and Psychological Conditions of Patients with Gastroesophageal Reflux Disease. Evid Based Complement Alternat Med. 2020 Sep 22;2020:5415813. doi: 10.1155/2020/5415813. eCollection 2020.
- BackgroundYIN, J., PENG, Z., SHI, L., CHEN, C., CHEN, Y., & LI, G. Visual analysis of related researches in the treatment of gastroesophageal reflux disease with traditional Chinese medicine based on Citespace. Journal of Clinical Medicine in Practice, 26(22), 65-71.
- Background: PubMed 34386592Goh KL, Lee YY, Leelakusolvong S, Makmun D, Maneerattanaporn M, Quach DT, Raja Ali RA, Sollano JD, Tran VH, Wong RK. Consensus statements and recommendations on the management of mild-to-moderate gastroesophageal reflux disease in the Southeast Asian region. JGH Open. 2021 Jul 31;5(8):855-863. doi: 10.1002/jgh3.12602. eCollection 2021 Aug.
- Background: PubMed 29977310Xiao J, Yang Y, Zhu Y, Qin Y, Li Y, Fu M, Zhai Z, Zhu L. Efficacy and Safety of Traditional Chinese Medicine on Nonerosive Reflux Disease: A Meta-Analysis of Randomized Controlled Trials. Evid Based Complement Alternat Med. 2018 May 24;2018:1505394. doi: 10.1155/2018/1505394. eCollection 2018.
- Background: PubMed 32242117Nirwan JS, Hasan SS, Babar ZU, Conway BR, Ghori MU. Global Prevalence and Risk Factors of Gastro-oesophageal Reflux Disease (GORD): Systematic Review with Meta-analysis. Sci Rep. 2020 Apr 2;10(1):5814. doi: 10.1038/s41598-020-62795-1.
- Background: PubMed 28232473Eusebi LH, Ratnakumaran R, Yuan Y, Solaymani-Dodaran M, Bazzoli F, Ford AC. Global prevalence of, and risk factors for, gastro-oesophageal reflux symptoms: a meta-analysis. Gut. 2018 Mar;67(3):430-440. doi: 10.1136/gutjnl-2016-313589. Epub 2017 Feb 23.
- Individual participant dataSharing planned: No. Individual participant data (IPD) will not be shared outside the research team in order to protect participant confidentiality and privacy.
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Post-Marketing Surveillance to Evaluate the Safety and Effectiveness of Zastaprazan Citrate
Erosive Gastroesophageal Reflux Disease
Recruiting
Mesh Vs Pledgets for Repair of Paraesophageal Hernia
Paraesophageal Hernia, GERD
Not yet recruitingPhase 4
Effects of Tirzepatide on Esophagogastric Junction Mechanics, Reflux Burden, and Gastric Physiology in Adults With Obesity
Obese Adults
Recruiting
Phrenoesophageal Ligament Reconstruction With Mesh
Hiatus Hernia, Gastreoesophageal Reflux Disease
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.
Thanh Tien Bui, MSc, MD principal investigator
Ho Chi Minh City Traditional Medicine Hospital
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing PDO Thread Embedding, Esomeprazole 40 mg Oral Tablet and Binh Vi Tablets in people with Gastroesophageal Reflux Disease (GERD), run by University of Medicine and Pharmacy at Ho Chi Minh City at 1 site 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 4 inclusion and 11 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 2 Nov 2026. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site 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?
Change in Gastroesophageal Reflux Disease Questionnaire (GerdQ) Score From Baseline to Week 4 (time frame: Baseline (T0) to week 4 (T4)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
On the ClinicalTrials.gov record for NCT07910656, which also lists 11 linked publications.
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 2 Nov 2026.