Thread-Embedding Acupuncture as an Adjunct to Proton Pump Inhibitor Therapy for Gastroesophageal Reflux Disease
28 de agosto de 2026 actualizado 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.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Tipo de estudio
Intervencionista
Inscripción (Estimado)
50
Fase
- No aplica
Contactos y Ubicaciones
Esta sección proporciona los datos de contacto de quienes realizan el estudio e información sobre dónde se lleva a cabo este estudio.
Estudio Contacto
- Nombre: Minh-Anh Nguyen Ngo Le, MD, PhD
- Número de teléfono: +84 962 644 648
- Correo electrónico: drminhanh@ump.edu.vn
Ubicaciones de estudio
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Ho Chi Minh City, Vietnam
- Reclutamiento
- Traditional Medicine Hospital of Ho Chi Minh City
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Contacto:
- Hien Thu Thi Le, MD
- Número de teléfono: +84886725372
- Correo electrónico: mingyingtcm@gmail.com
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Criterios de participación
Los investigadores buscan personas que se ajusten a una determinada descripción, denominada criterio de elegibilidad. Algunos ejemplos de estos criterios son el estado de salud general de una persona o tratamientos previos.
Criterio de elegibilidad
Edades elegibles para estudiar
- Adulto
Acepta Voluntarios Saludables
No
Descripción
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.
Plan de estudios
Esta sección proporciona detalles del plan de estudio, incluido cómo está diseñado el estudio y qué mide el estudio.
¿Cómo está diseñado el estudio?
Detalles de diseño
- Propósito principal: Tratamiento
- Asignación: Aleatorizado
- Modelo Intervencionista: Asignación paralela
- Enmascaramiento: Único
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
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Comparador activo: 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.
Otros nombres:
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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.
Otros nombres:
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¿Qué mide el estudio?
Medidas de resultado primarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Change in GERD-Q Score
Periodo de tiempo: 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 resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
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Treatment Response Based on GerdQ
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Periodo de tiempo: 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
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
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
Fechas de registro del estudio
Estas fechas rastrean el progreso del registro del estudio y los envíos de resultados resumidos a ClinicalTrials.gov. Los registros del estudio y los resultados informados son revisados por la Biblioteca Nacional de Medicina (NLM) para asegurarse de que cumplan con los estándares de control de calidad específicos antes de publicarlos en el sitio web público.
Fechas importantes del estudio
Inicio del estudio (Actual)
15 de abril de 2026
Finalización primaria (Estimado)
15 de septiembre de 2026
Finalización del estudio (Estimado)
18 de septiembre de 2026
Fechas de registro del estudio
Enviado por primera vez
26 de agosto de 2026
Primero enviado que cumplió con los criterios de control de calidad
28 de agosto de 2026
Publicado por primera vez (Actual)
1 de septiembre de 2026
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
1 de septiembre de 2026
Última actualización enviada que cumplió con los criterios de control de calidad
28 de agosto de 2026
Última verificación
1 de agosto de 2026
Más información
Términos relacionados con este estudio
Palabras clave
Términos MeSH relevantes adicionales
Otros números de identificación del estudio
- TEA-GERD-RCT2026
Plan de datos de participantes individuales (IPD)
¿Planea compartir datos de participantes individuales (IPD)?
NO
Información sobre medicamentos y dispositivos, documentos del estudio
Estudia un producto farmacéutico regulado por la FDA de EE. UU.
No
Estudia un producto de dispositivo regulado por la FDA de EE. UU.
No
Esta información se obtuvo directamente del sitio web clinicaltrials.gov sin cambios. Si tiene alguna solicitud para cambiar, eliminar o actualizar los detalles de su estudio, comuníquese con register@clinicaltrials.gov. Tan pronto como se implemente un cambio en clinicaltrials.gov, también se actualizará automáticamente en nuestro sitio web. .