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COMPLETED

NCT07910656

PDO Thread Embedding Plus Binh Vi Tablets for Gastroesophageal Reflux Disease

Sponsor: University of Medicine and Pharmacy at Ho Chi Minh City

View on ClinicalTrials.gov

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. 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.

Official title: Evaluation of the Effectiveness of PDO Thread Embedding Combined With Binh Vi Tablets in the Treatment of Gastroesophageal Reflux Disease (GERD)

Key Details

Gender

All

Age Range

18 Years - 60 Years

Study Type

INTERVENTIONAL

Enrollment

Start Date

2026-03-20

Completion Date

2026-08-31

Last Updated

2026-11-02

Healthy Volunteers

Conditions

Gastroesophageal Reflux Disease (GERD)

Interventions

PROCEDURE

PDO Thread Embedding

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.

DRUG

Esomeprazole 40 mg Oral Tablet

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.

DRUG

Binh Vi Tablets

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.

Inclusion Criteria: * 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. Exclusion Criteria: * 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. * 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.

Locations (1)

Ho Chi Minh City Traditional Medicine Hospital

Ho Chi Minh City, Vietnam