Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
10 de mayo de 2022 actualizado por: Xiyuan Hospital of China Academy of Chinese Medical Sciences
A Multicenter, Randomized, Double-Blind, Placebo-Controlled Clinical Trial of WPQW Granule for Overlap of Non-Erosive Reflux Disease(NERD) and Diarrhea Predominant Diarrhea Irritable Bowel Syndrome(IBS-D)
Non-erosive reflux disease（NERD）and Diarrhea-Predominant Irritable Bowel Syndrome（IBS-D）are both the common refractory gastrointestinal diseases.
Patients, who suffered from overlapping symptoms of NERD and IBS-D, present more serious symptom manifestation, anxiety, and worse life quality than those with solely disease.
There is lack of effective treatment for overlapping gastrointestinal symptoms.
Traditional Chinese Medicine (TCM) syndrome differentiation and treatment has the advantages of overall regulation and individualized treatment, but lack of high-level evidence.
The purpose of this study is to evaluate the efficacy and safety of WPQW granule for the treatment of NERD overlapping IBS-D.
Descripción general del estudio
Estado
Reclutamiento
Condiciones
Intervención / Tratamiento
Descripción detallada
Gastroesophageal reflux disease (GERD) is a chronic relapsing acid-peptic disorder that is caused by the reflux of gastric or duodenum content.
Non-erosive reflux disease（NERD）, which account for 70%, is the most common type of GERD in the Asian population.
Diarrhea-Predominant Irritable Bowel Syndrome（IBS-D）is the mainly subtype of IBS, and the prevalence was found to be 46% in IBS.
Both diseases aforementioned are common and frequent chronic diseases in the world, and the pathogenesis of which has not been fully defined.
Current studies have shown that GERD can present in patients with IBS, vice versa.
Up to 79% of patients with IBS co-exist with GERD-like symptoms, and 71% of patients with GERD co-exist with IBS-like symptoms.
For those patients, they suffer from more serious symptom manifestation, anxiety, and worse life quality those with solely disease.
The diagnosis and treatment of Functional gastrointestinal disorders (FGIDs) mostly based on the idea of segmental diagnosis and single-target therapy in modern medicine, and there is lack of effective treatment for overlapping gastrointestinal symptoms.
The advantages of holistic diagnosis therapy and individualized treatment in Traditional Chinese Medicine（TCM）have attracted international attention, but there is still lack of high-level evidence-based medical evidence for the treatment of symptom overlap in FGIDs in TCM.
In this study, we propose to conduct a multicenter, randomized, double-blind, placebo-controlled clinical study of WPQW granule for the treatment of NERD overlapping IBS-D to evaluate the efficacy and safety of WPQW granule with the aim of obtaining high-level evidence-based medical evidence.
Tipo de estudio
Intervencionista
Inscripción (Anticipado)
216
Fase
- Fase temprana 1
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: Fengyun Wang, M.D
- Número de teléfono: +86(010)62835248
- Correo electrónico: wfy811@163.com
Ubicaciones de estudio
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Beijing
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Beijing, Beijing, Porcelana, 100091
- Reclutamiento
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
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Contacto:
- Fengyun Wang, M.D
- Número de teléfono: +86(010)62835248
- Correo electrónico: wfy811@163.com
-
-
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
18 años a 70 años (Adulto, Adulto Mayor)
Acepta Voluntarios Saludables
No
Géneros elegibles para el estudio
Todos
Descripción
Inclusion Criteria:
- Patients diagnosed with NERD and IBS-D simultaneously
- Patients who present cardinal symptoms like reflux, heartburn, abdominal pain/bloating, diarrhea, etc
- Patients diagnosed with syndrome of intermingled cold and heat of traditional Chinese medicine
- Patients have informed consent and are willing to receive corresponding treatment
Exclusion Criteria:
- Patients with hiatal hernia
- Patients with upper gastrointestinal bleeding, peptic ulcer, gastrointestinal tumor, chronic atrophic gastritis with dysplasia
- Patients with other serious organic diseases, such as acute cardiovascular disease, acute and chronic pancreatitis, cirrhosis, abnormal liver function (transaminases more than 1.5 times of normal value), abnormal thyroid function, diabetes mellitus with a history of more than 10 years, chronic renal insufficiency, hematologic disorders, and hematologic disorders, etc
- Patients with neurological disease or psychiatric impairment like severe anxiety, depression requiring long-term drug treatment
- Patients who cannot stop taking acid suppressants for a long time
- Alcohol or drug dependency or abuse
- Pregnant or lactating women
- Patients who have a history of allergies to all the test drugs
- Patients who are participating in other clinical trials or have participated in other clinical trials within 3 months
- Patients who, in the opinion of the investigator, are not suitable to participate in clinical trial
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: Triple
Armas e Intervenciones
Grupo de participantes/brazo |
Intervención / Tratamiento |
|---|---|
|
Experimental: Experimental group
Oral administration of WPQW granule with warm water，2 sachets each time, 3 times a day, 1.5-2 hours after a meal.
The medication period was 4 weeks.
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WPQW granule, 2 sachets / time, 3 times / day.
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Comparador de placebos: Control group
Oral administration of WPQW granule simulant，which containing 5% WPQW granule，with warm water，2 sachets each time, 3 times a day, 1.5-2 hours after a meal.
The medication period was 4 weeks.
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WPQW granule simulant, 2 sachets / time, 3 times / day.
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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 of visual analogue scale (VAS) score of symptoms of reflux and heartburn
Periodo de tiempo: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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During the medication period, the patients recorded the reflux and heartburn episodes (frequency and duration) within 24 hours per day on the symptom diary card, and VAS scores for reflux and heartburn symptoms was calculated as the mean score of each symptom in the past week.
The episodes in the week before medication were used as the baseline, the mean score of any symptom decreased ≥50% from the baseline was recorded as response after weekly treatment, and the number of response weeks was considered effective if it was greater than 50% of the weeks of the whole treatment period.
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baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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Change of visual analogue scale (VAS) score of symptoms of abdominal pain and diarrhea
Periodo de tiempo: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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During the medication period, the patients recorded the of abdominal pain (pain severity and frequency) and diarrhea (stool consistency and frequency based on Bristol stool form scale) within 24 hours per day on the symptom diary card.
VAS score was conducted for the most severe abdominal pain, and the mean score was calculated for each week, with the week of episodes prior to medication administration as the baseline.
It was considered effective when the weekly mean score decrease of at least 30% from baseline and the days of at least once type 6 or type 7 stool Bristol stool form every week decrease of at least 30% from baseline, referring to the efficacy evaluation of the technical guidelines for clinical studies of Chinese medicine for IBS published in 2017.
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baseline, 4 weeks during treatment period, 4 weeks during follow-up period
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Medidas de resultado secundarias
Medida de resultado |
Medida Descripción |
Periodo de tiempo |
|---|---|---|
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Change of traditional Chinese Medicine syndrome score
Periodo de tiempo: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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The symptoms related to syndrome of intermingled cold and heat were scored.
The cardinal symptom was scored 0, 2, 4, 6 and the secondary symptom scored 0, 1, 2, 3 respectively according to severity of each symptom.
Total symptom score represented the syndrome score.
Reduction in syndrome score represented Improvement.
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Change of 36-item short-form (SF-36) score
Periodo de tiempo: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Health status was evaluated by a 36-item short-form (SF-36) containing eight health concepts.
If the score descends, it indicates that the patient's condition has improved.
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Change of FGI-checklist score
Periodo de tiempo: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
A 20-item FGI-checklist was used to evaluate comprehensive symptom severity of Functional Gastrointestinal Disorder (FGID), which covering esophageal, dyspeptic and bowel symptoms.
If the score descends, it indicates that the patient's condition has improved.
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baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Change of Hospital Anxiety and Depression Scale (HAD) score
Periodo de tiempo: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
Hospital Anxiety and Depression Scale (HAD) score was used to evaluate the efficacy of experimental drug.
Reduction in total score represented Improvement
|
baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
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Colaboradores e Investigadores
Aquí es donde encontrará personas y organizaciones involucradas en este estudio.
Colaboradores
Investigadores
- Investigador principal: Xudong Tang, M.D, China Academy of Chinese Medical Sciences
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)
1 de diciembre de 2021
Finalización primaria (Anticipado)
1 de mayo de 2023
Finalización del estudio (Anticipado)
1 de mayo de 2023
Fechas de registro del estudio
Enviado por primera vez
8 de mayo de 2022
Primero enviado que cumplió con los criterios de control de calidad
10 de mayo de 2022
Publicado por primera vez (Actual)
11 de mayo de 2022
Actualizaciones de registros de estudio
Última actualización publicada (Actual)
11 de mayo de 2022
Última actualización enviada que cumplió con los criterios de control de calidad
10 de mayo de 2022
Última verificación
1 de diciembre de 2021
Más información
Términos relacionados con este estudio
Términos MeSH relevantes adicionales
- Enfermedades del Sistema Digestivo
- Procesos Patológicos
- Enfermedad
- Signos y Síntomas Digestivos
- Enfermedades Gastrointestinales
- Enfermedades del Colon Funcionales
- Enfermedades del Colon
- Enfermedades intestinales
- Trastornos de la motilidad esofágica
- Trastornos de la deglución
- Enfermedades esofágicas
- Síndrome
- Síndrome del intestino irritable
- Diarrea
- Reflujo gastroesofágico
Otros números de identificación del estudio
- ZYYCXTD-C-202010
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
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