Thread-Embedding Acupuncture plus a Proton Pump Inhibitor for GERD

Is this trial a fit for you?

A plain-English reading of the study's rules. Only the study team can confirm whether you qualify.

What this trial studies

This interventional trial compares thread-embedding acupuncture plus omeprazole to standard therapy in adults with GERD. Participants must have GERD symptoms, a GerdQ score of 8 or higher, and meet traditional medicine criteria for Liver-Stomach Heat stagnation. The study will evaluate safety and effectiveness through clinical outcomes, following a predefined protocol. Recruitment is at the Traditional Medicine Hospital of Ho Chi Minh City under the lead sponsor, University of Science Ho Chi Minh City.

Why it matters

Who can join: the full rules

Inclusion Criteria:

* Aged 18 to 60 years.
* Diagnosed with gastroesophageal reflux disease (GERD) with a GerdQ score ≥8 and typical heartburn and/or regurgitation occurring at least 2 days per week, and considered eligible for proton pump inhibitor therapy according to the ACG 2013 guideline.
* Meets the diagnostic criteria for Liver-Stomach Heat Stagnation Syndrome according to the 2017 expert consensus on traditional medicine syndrome differentiation for GERD.
* No previous diagnosis of GERD within the past 8 weeks.
* Voluntarily agrees to participate in the study and provides written informed consent.

Exclusion Criteria:

* Presence of alarm symptoms, including dysphagia, odynophagia, palpable lymph nodes or mass, unintentional weight loss, family history of gastrointestinal malignancy, gastrointestinal bleeding, anemia, or persistent nausea/vomiting.
* Structural gastrointestinal disease confirmed by endoscopy, including esophageal malignancy or other significant organic lesions.
* Current use of medications that may influence GERD assessment or treatment, including glucocorticoids, NSAIDs, bisphosphonates, prostaglandins, oral contraceptives, antifungal agents, or sedative medications.
* Use of proton pump inhibitors, H2-receptor antagonists, or prokinetic agents within the previous 14 days.
* History of hypersensitivity to proton pump inhibitors or absorbable catgut/thread material.
* Skin inflammation, infection, or other dermatologic disease at or around the intended thread-embedding sites.
* Current pregnancy or breastfeeding.
* Currently participating in another interventional clinical study.

Where it's running

• Traditional Medicine Hospital of Ho Chi Minh City
  Ho Chi Minh City, Vietnam Recruiting

Study contacts

• Principal investigator: Minh-Anh Nguyen Ngo Le, MD,PhD — University of Medicine and Pharmacy at Ho Chi Minh City
• Study coordinator: Minh-Anh Nguyen Ngo Le, MD, PhD
• Email: drminhanh@ump.edu.vn
• Phone: +84 962 644 648

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How to take part

1. Review the eligibility criteria above with your treating physician.
2. Check the official listing on ClinicalTrials.gov for the latest contact details and recruitment status.
3. Contact the study coordinator or principal investigator to ask for pre-screening. Pre-screening is free and never obligates you to enroll.