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RECRUITING Not applicable ClinicalTrials.gov

Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease

Sponsor: University of Science Ho Chi Minh City • ClinicalTrials.gov ID: NCT07797959

Registry updated: 2026-09-01
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Description

This study aims to evaluate the effectiveness of thread-embedding acupuncture combined with omeprazole in patients with gastroesophageal reflux disease (GERD) presenting with the traditional medicine pattern of Liver-Stomach constraint-heat. Participants will receive either thread-embedding acupuncture combined with omeprazole or the comparator treatment according to the study protocol. Clinical outcomes will be assessed to determine the effectiveness and safety of the intervention.

Interventions

  • Thread-Embedding Acupuncture (Procedure)
    Participants will receive acupoint catgut embedding in addition to standard treatment with omeprazole. Acupoint catgut embedding will be performed twice during the 4-week treatment period, at 2-week intervals. Sterile chromic catgut 3/0 will be embedded at Zhongwan (CV12), Shangwan (CV13), Xiawan (CV10), Zusanli (ST36), Tianshu (ST25), and Taichong (LR3) according to the standardized procedure. Participants will be monitored for 30 minutes after each procedure for adverse events.

Eligibility criteria

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.

Conditions

GERD Gastroesophageal Reflux Disease

Locations

  • Traditional Medicine Hospital of Ho Chi Minh City — Ho Chi Minh City, Vietnam
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Official Source

Data sourced from ClinicalTrials.gov, a service of the U.S. National Institutes of Health.

View Official Record