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

NCT07797959 | Recruiting

• 1 other identifier: TEA-GERD-RCT2026
• Study Type: interventional
• Target: 50
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

GERD; Gastroesophageal Reflux Disease

Keywords

Liver-Stomach constraint-heat; Traditional medicine; Acupoint catgut embedding; Thread-embedding acupuncture; Omeprazole

Outcome Measures

Primary Outcomes (1)

• Change in GERD-Q Score

  Gastroesophageal reflux disease symptoms will be assessed using the Gastroesophageal Reflux Disease Questionnaire (GerdQ). The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. Change in the total GerdQ score from baseline to 4 weeks will be assessed between the two study groups.

  Baseline and 4 weeks

Secondary Outcomes (5)

• Treatment Response Based on GerdQ

  Baseline and weekly through 4 weeks

• Complete Symptom Resolution Based on GerdQ

  4 weeks

• Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome

  Baseline and weekly through 4 weeks

• Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score

  Baseline and 4 weeks

• Adverse Events Associated With Thread-Embedding Acupuncture

  Throughout the 4-week treatment period

Study Arms (2)

Omeprazole

ACTIVE COMPARATOR

Participants receive omeprazole according to the treatment regimen specified in the study protocol.

Procedure: Thread-Embedding Acupuncture

Thread-Embedding Acupuncture Plus Omeprazole

EXPERIMENTAL

Participants receive thread-embedding acupuncture in combination with omeprazole according to the treatment regimen specified in the study protocol.

Procedure: Thread-Embedding Acupuncture

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.

Also known as: Acupoint Catgut Embedding

Omeprazole; Thread-Embedding Acupuncture Plus Omeprazole

Eligibility Criteria

• Age: 18 Years - 60 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64)

You may qualify if:

• 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.

You may not qualify if:

• 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.

Sponsors & Collaborators

• University of Science Ho Chi Minh City: lead

Study Sites (1)

Traditional Medicine Hospital of Ho Chi Minh City

Ho Chi Minh City, Vietnam

RECRUITING

MeSH Terms

Conditions

Gastroesophageal Reflux

Condition Hierarchy (Ancestors)

Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases

Study Officials

• Minh-Anh Nguyen Ngo Le, MD,PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

• Minh-Anh Nguyen Ngo Le, MD, PhD

  University of Medicine and Pharmacy at Ho Chi Minh City

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Minh-Anh Nguyen Ngo Le, MD, PhD

CONTACT

+84 962 644 648; drminhanh@ump.edu.vn

Study Design

• Study Type: interventional
• Phase: not applicable
• Allocation: RANDOMIZED
• Masking: SINGLE
• Who Masked: OUTCOMES ASSESSOR
• Masking Details: Participants were not blinded because the thread-embedding acupuncture intervention could not be concealed. The investigator responsible for post-intervention outcome assessment and data analysis was blinded to treatment allocation.
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Principal Investigator

Study Record Dates

• First Submitted: August 26, 2026
• First Posted: September 1, 2026
• Study Start: April 15, 2026
• Primary Completion: September 15, 2026
• Study Completion: September 18, 2026
• Last Updated: September 1, 2026

Record last verified: 2026-08

Data Sharing

• IPD Sharing: Will not share

Locations

VN (1)