An interventional study of PDO Thread Embedding and Esomeprazole 40 mg Oral Tablet in Gastroesophageal Reflux Disease (GERD), sponsored by University of Medicine and Pharmacy at Ho Chi Minh City. Completed at 1 site in Vietnam. Open to participants aged 18 Years to 60 Years. Per ClinicalTrials.gov, last updated 2026-11-02.
Sponsored by University of Medicine and Pharmacy at Ho Chi Minh City · Not applicable, Interventional, and Treatment
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:
Participants will:
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.
1,211 studies on the registry are indexed under Gastroesophageal Reflux; 202 are open to participants now.
This study's enrollment of 86 is above the median of 68 across 796 interventional studies indexed under Gastroesophageal Reflux.
Browse Gastroesophageal Reflux studies →University of Medicine and Pharmacy at Ho Chi Minh City is the lead sponsor of 127 studies on the registry; 44 are open to participants now.
Counted across the registry records on this site, refreshed daily.
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:
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.
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Corticosteroids (steroids)
Anti-inflammatory medicines such as prednisone, prednisolone and dexamethasone — not the anabolic steroids used for muscle.
Studies differ in what they allow: check which steroid medicines, routes (tablets, injections, creams, inhalers, eye drops) and doses this study accepts.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
HIV
The human immunodeficiency virus, which weakens the immune system.
Many studies now accept people whose HIV is controlled on treatment, judged by the viral load and the CD4 count. Check the limits this study sets.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Washout period
A planned gap after a treatment, so that its effects can lessen before the study treatment or a study assessment. Ask the study team and the doctor who prescribed it before changing any medicine.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Contraindication
A reason a treatment, test or procedure should not be given to a particular person, such as an allergy, another illness or a medicine they take.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Excipients
The other ingredients in a medicine besides the active drug, such as fillers, colours or preservatives.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Participants receive PDO thread embedding twice over 4 weeks, once every 2 weeks, in addition to Esomeprazole 40 mg and Binh Vi tablets.
Procedure: PDO Thread Embedding · Drug: Esomeprazole 40 mg Oral Tablet · Drug: Binh Vi Tablets
Participants receive Esomeprazole 40 mg and Binh Vi tablets alone for 4 weeks, without PDO thread embedding.
Drug: Esomeprazole 40 mg Oral Tablet · Drug: Binh Vi Tablets
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 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 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.
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.
Time frame: Baseline (T0) to week 4 (T4)
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.
Time frame: 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.
Time frame: 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.
Time frame: 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.
Time frame: From baseline (T0) through week 4 (T4)
Plan to share: No — Individual participant data (IPD) will not be shared outside the research team in order to protect participant confidentiality and privacy.
Ran from Mar 2026 to primary completion in Aug 2026, 5 months.
Of 192 non-industry interventional studies with no phase under Gastroesophageal Reflux, half reached primary completion within 31 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 68. This study's 5 months is below that.
Counting every sponsor, half of 225 studies reached it within 32 months; a quarter within 12 and three quarters within 68.
How these figures are worked out, and which studies are left out of them.
From the registry record's own update history. This site started tracking changes on Sep 25, 2026; for anything earlier, see the record history on ClinicalTrials.gov ↗
This study is completed, as verified in Oct 2026. You cannot join it, but the record below documents what was studied.
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