Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease
28 de agosto de 2026 atualizado por: 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.
Visão geral do estudo
Status
Recrutamento
Condições
Intervenção / Tratamento
Tipo de estudo
Intervencional
Inscrição (Estimado)
50
Estágio
- Não aplicável
Contactos e Locais
Esta seção fornece os detalhes de contato para aqueles que conduzem o estudo e informações sobre onde este estudo está sendo realizado.
Contato de estudo
- Nome: Minh-Anh Nguyen Ngo Le, MD, PhD
- Número de telefone: +84 962 644 648
- E-mail: drminhanh@ump.edu.vn
Locais de estudo
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Ho Chi Minh City, Vietnã
- Recrutamento
- Traditional Medicine Hospital of Ho Chi Minh City
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Contato:
- Hien Thu Thi Le, MD
- Número de telefone: +84886725372
- E-mail: mingyingtcm@gmail.com
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Critérios de participação
Os pesquisadores procuram pessoas que se encaixem em uma determinada descrição, chamada de critérios de elegibilidade. Alguns exemplos desses critérios são a condição geral de saúde de uma pessoa ou tratamentos anteriores.
Critérios de elegibilidade
Idades elegíveis para estudo
- Adulto
Aceita Voluntários Saudáveis
Não
Descrição
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.
Plano de estudo
Esta seção fornece detalhes do plano de estudo, incluindo como o estudo é projetado e o que o estudo está medindo.
Como o estudo é projetado?
Detalhes do projeto
- Finalidade Principal: Tratamento
- Alocação: Randomizado
- Modelo Intervencional: Atribuição Paralela
- Mascaramento: Solteiro
Armas e Intervenções
Grupo de Participantes / Braço |
Intervenção / Tratamento |
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Comparador Ativo: Omeprazole
Participants receive omeprazole according to the treatment regimen specified in the study protocol.
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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.
Outros nomes:
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Experimental: Thread-Embedding Acupuncture Plus Omeprazole
Participants receive thread-embedding acupuncture in combination with omeprazole according to the treatment regimen specified in the study protocol.
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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.
Outros nomes:
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O que o estudo está medindo?
Medidas de resultados primários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Change in GERD-Q Score
Prazo: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Medidas de resultados secundários
Medida de resultado |
Descrição da medida |
Prazo |
|---|---|---|
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Treatment Response Based on GerdQ
Prazo: Baseline and weekly through 4 weeks
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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.
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Baseline and weekly through 4 weeks
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Complete Symptom Resolution Based on GerdQ
Prazo: 4 weeks
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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.
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4 weeks
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Change in Traditional Medicine Symptoms of Liver-Stomach Heat Stagnation Syndrome
Prazo: Baseline and weekly through 4 weeks
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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.
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Baseline and weekly through 4 weeks
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Treatment Response Based on Liver-Stomach Stagnated Heat Syndrome Score
Prazo: Baseline and 4 weeks
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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.
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Baseline and 4 weeks
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Adverse Events Associated With Thread-Embedding Acupuncture
Prazo: Throughout the 4-week treatment period
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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.
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Throughout the 4-week treatment period
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Colaboradores e Investigadores
É aqui que você encontrará pessoas e organizações envolvidas com este estudo.
Patrocinador
Investigadores
- Investigador principal: Minh-Anh Nguyen Ngo Le, MD,PhD, University of Medicine and Pharmacy at Ho Chi Minh City
- Investigador principal: Minh-Anh Nguyen Ngo Le, MD, PhD, University of Medicine and Pharmacy at Ho Chi Minh City
Datas de registro do estudo
Essas datas acompanham o progresso do registro do estudo e os envios de resumo dos resultados para ClinicalTrials.gov. Os registros do estudo e os resultados relatados são revisados pela National Library of Medicine (NLM) para garantir que atendam aos padrões específicos de controle de qualidade antes de serem publicados no site público.
Datas Principais do Estudo
Início do estudo (Real)
15 de abril de 2026
Conclusão Primária (Estimado)
15 de setembro de 2026
Conclusão do estudo (Estimado)
18 de setembro de 2026
Datas de inscrição no estudo
Enviado pela primeira vez
26 de agosto de 2026
Enviado pela primeira vez que atendeu aos critérios de CQ
28 de agosto de 2026
Primeira postagem (Real)
1 de setembro de 2026
Atualizações de registro de estudo
Última Atualização Postada (Real)
1 de setembro de 2026
Última atualização enviada que atendeu aos critérios de controle de qualidade
28 de agosto de 2026
Última verificação
1 de agosto de 2026
Mais Informações
Termos relacionados a este estudo
Palavras-chave
Termos MeSH relevantes adicionais
Outros números de identificação do estudo
- TEA-GERD-RCT2026
Plano para dados de participantes individuais (IPD)
Planeja compartilhar dados de participantes individuais (IPD)?
NÃO
Informações sobre medicamentos e dispositivos, documentos de estudo
Estuda um medicamento regulamentado pela FDA dos EUA
Não
Estuda um produto de dispositivo regulamentado pela FDA dos EUA
Não
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