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

28. august 2026 opdateret af: Dr Nguyen Ngo Le Minh Anh MD, PhD, University of Science Ho Chi Minh City

Efficacy and Safety of Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy in Patients With Gastroesophageal Reflux Disease and Liver-Stomach Stagnation-Heat Syndrome: A Randomized Controlled Trial

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.

Studieoversigt

Status

Rekruttering

Betingelser

Intervention / Behandling

Undersøgelsestype

Interventionel

Tilmelding (Anslået)

50

Fase

  • Ikke anvendelig

Kontakter og lokationer

Dette afsnit indeholder kontaktoplysninger for dem, der udfører undersøgelsen, og oplysninger om, hvor denne undersøgelse udføres.

Studiekontakt

Studiesteder

  • Vietnam
      • Ho Chi Minh City, Vietnam
        • Rekruttering
        • Traditional Medicine Hospital of Ho Chi Minh City
        • Kontakt:

Deltagelseskriterier

Forskere leder efter personer, der passer til en bestemt beskrivelse, kaldet berettigelseskriterier. Nogle eksempler på disse kriterier er en persons generelle helbredstilstand eller tidligere behandlinger.

Berettigelseskriterier

Aldre berettiget til at studere

  • Voksen

Tager imod sunde frivillige

Ingen

Beskrivelse

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.

Studieplan

Dette afsnit indeholder detaljer om studieplanen, herunder hvordan undersøgelsen er designet, og hvad undersøgelsen måler.

Hvordan er undersøgelsen tilrettelagt?

Design detaljer

  • Primært formål: Behandling
  • Tildeling: Randomiseret
  • Interventionel model: Parallel tildeling
  • Maskning: Enkelt

Våben og indgreb

Deltagergruppe / Arm
Intervention / Behandling
Aktiv komparator: Omeprazole
Participants receive omeprazole according to the treatment regimen specified in the study protocol.
Procedure: Thread-Embedding Acupuncture
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.
Andre navne:
  • Acupoint Catgut Embedding
Eksperimentel: Thread-Embedding Acupuncture Plus Omeprazole
Participants receive thread-embedding acupuncture in combination with omeprazole according to the treatment regimen specified in the study protocol.
Procedure: Thread-Embedding Acupuncture
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.
Andre navne:
  • Acupoint Catgut Embedding

Hvad måler undersøgelsen?

Primære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Change in GERD-Q Score
Tidsramme: Baseline and 4 weeks
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

Sekundære resultatmål

Resultatmål
Foranstaltningsbeskrivelse
Tidsramme
Treatment Response Based on GerdQ
Tidsramme: Baseline and weekly through 4 weeks
Treatment response will be defined as a reduction of at least 2 points in the total Gastroesophageal Reflux Disease Questionnaire (GerdQ) score from baseline. The total GerdQ score ranges from 0 to 18, with higher scores indicating more severe gastroesophageal reflux disease symptoms. The proportion of participants achieving treatment response will be compared between the two study groups.
Baseline and weekly through 4 weeks
Complete Symptom Resolution Based on GerdQ
Tidsramme: 4 weeks
Complete resolution of typical gastroesophageal reflux disease (GERD) 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 GERD symptoms. Complete symptom resolution will be defined as a score of 0 for both the heartburn and regurgitation items of the GerdQ. The proportion of participants achieving complete symptom resolution at 4 weeks will be compared between the two study groups.
4 weeks
Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome
Tidsramme: Baseline and weekly through 4 weeks
Traditional medicine symptoms of Liver-Stomach Stagnated Heat syndrome will be assessed using a syndrome symptom score comprising two main symptoms (burning sensation and acid regurgitation) and six secondary symptoms (retrosternal pain, epigastric burning pain, epigastric fullness, belching or food regurgitation, irritability, and rapid hunger). Each main symptom is rated as absent, mild, moderate, or severe and scored 0, 2, 4, or 6 points, respectively. Each secondary symptom is rated as absent, mild, moderate, or severe and scored 0, 1, 2, or 3 points, respectively. The total score ranges from 0 to 30, with higher scores indicating greater syndrome severity. Change in the total syndrome score from baseline through 4 weeks will be compared between the two study groups.
Baseline and weekly through 4 weeks
Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score
Tidsramme: Baseline and 4 weeks
Treatment response for Liver-Stomach Stagnated Heat syndrome will be assessed using the percentage reduction in the total syndrome score from baseline. The efficacy index will be calculated as [(baseline score - post-treatment score) / baseline score] × 100. Clinical cure is defined as an efficacy index of at least 95%, markedly effective as 70% to less than 95%, effective as 30% to less than 70%, and ineffective as less than 30%. The proportion of participants classified as clinically cured, markedly effective, effective, or ineffective at 4 weeks will be compared between the two study groups.
Baseline and 4 weeks
Adverse Events Associated With Thread-Embedding Acupuncture
Tidsramme: Throughout the 4-week treatment period
Adverse events associated with thread-embedding acupuncture will be monitored throughout the 4-week treatment period. Events of interest include local pain, bleeding, bruising, swelling, infection, allergic reactions, and other treatment-related complications. The number and proportion of participants experiencing at least one adverse event will be recorded and compared between the two study groups.
Throughout the 4-week treatment period

Samarbejdspartnere og efterforskere

Det er her, du vil finde personer og organisationer, der er involveret i denne undersøgelse.

Sponsor

University of Science Ho Chi Minh City

Efterforskere

  • Ledende efterforsker: Minh-Anh Nguyen Ngo Le, MD,PhD, University of Medicine and Pharmacy at Ho Chi Minh City
  • Ledende efterforsker: Minh-Anh Nguyen Ngo Le, MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City

Datoer for undersøgelser

Disse datoer sporer fremskridtene for indsendelser af undersøgelsesrekord og resumeresultater til ClinicalTrials.gov. Studieregistreringer og rapporterede resultater gennemgås af National Library of Medicine (NLM) for at sikre, at de opfylder specifikke kvalitetskontrolstandarder, før de offentliggøres på den offentlige hjemmeside.

Studer store datoer

Studiestart (Faktiske)

15. april 2026

Primær færdiggørelse (Anslået)

15. september 2026

Studieafslutning (Anslået)

18. september 2026

Datoer for studieregistrering

Først indsendt

26. august 2026

Først indsendt, der opfyldte QC-kriterier

28. august 2026

Først opslået (Faktiske)

1. september 2026

Opdateringer af undersøgelsesjournaler

Sidste opdatering sendt (Faktiske)

1. september 2026

Sidste opdatering indsendt, der opfyldte kvalitetskontrolkriterier

28. august 2026

Sidst verificeret

1. august 2026

Mere information

Begreber relateret til denne undersøgelse

Nøgleord

Yderligere relevante MeSH-vilkår

Andre undersøgelses-id-numre

  • TEA-GERD-RCT2026

Plan for individuelle deltagerdata (IPD)

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