- ICH GCP
- Registre américain des essais cliniques
- Essai clinique NCT05369884
Efficacy and Safety of WPQW Granule for Overlap of NERD and IBS-D
10 mai 2022 mis à jour par: 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.
Aperçu de l'étude
Statut
Recrutement
Intervention / Traitement
Description détaillée
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.
Type d'étude
Interventionnel
Inscription (Anticipé)
216
Phase
- Première phase 1
Contacts et emplacements
Cette section fournit les coordonnées de ceux qui mènent l'étude et des informations sur le lieu où cette étude est menée.
Coordonnées de l'étude
- Nom: Fengyun Wang, M.D
- Numéro de téléphone: +86(010)62835248
- E-mail: wfy811@163.com
Lieux d'étude
-
-
Beijing
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Beijing, Beijing, Chine, 100091
- Recrutement
- Xiyuan Hospital of China Academy of Chinese Medical Sciences
-
Contact:
- Fengyun Wang, M.D
- Numéro de téléphone: +86(010)62835248
- E-mail: wfy811@163.com
-
-
Critères de participation
Les chercheurs recherchent des personnes qui correspondent à une certaine description, appelée critères d'éligibilité. Certains exemples de ces critères sont l'état de santé général d'une personne ou des traitements antérieurs.
Critère d'éligibilité
Âges éligibles pour étudier
18 ans à 70 ans (Adulte, Adulte plus âgé)
Accepte les volontaires sains
Non
Sexes éligibles pour l'étude
Tout
La description
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 d'étude
Cette section fournit des détails sur le plan d'étude, y compris la façon dont l'étude est conçue et ce que l'étude mesure.
Comment l'étude est-elle conçue ?
Détails de conception
- Objectif principal: Traitement
- Répartition: Randomisé
- Modèle interventionnel: Affectation parallèle
- Masquage: Tripler
Armes et Interventions
Groupe de participants / Bras |
Intervention / Traitement |
---|---|
Expérimental: 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.
|
WPQW granule, 2 sachets / time, 3 times / day.
|
Comparateur placebo: 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.
|
WPQW granule simulant, 2 sachets / time, 3 times / day.
|
Que mesure l'étude ?
Principaux critères de jugement
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of visual analogue scale (VAS) score of symptoms of reflux and heartburn
Délai: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
|
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
Délai: baseline, 4 weeks during treatment period, 4 weeks during follow-up period
|
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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Mesures de résultats secondaires
Mesure des résultats |
Description de la mesure |
Délai |
---|---|---|
Change of traditional Chinese Medicine syndrome score
Délai: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
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.
|
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
Délai: baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
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.
|
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
Délai: 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.
|
baseline, week 2, week 4 during treatment period, week 6 and week 8 during follow-up period
|
Change of Hospital Anxiety and Depression Scale (HAD) score
Délai: 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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Collaborateurs et enquêteurs
C'est ici que vous trouverez les personnes et les organisations impliquées dans cette étude.
Collaborateurs
Les enquêteurs
- Chercheur principal: Xudong Tang, M.D, China Academy of Chinese Medical Sciences
Dates d'enregistrement des études
Ces dates suivent la progression des dossiers d'étude et des soumissions de résultats sommaires à ClinicalTrials.gov. Les dossiers d'étude et les résultats rapportés sont examinés par la Bibliothèque nationale de médecine (NLM) pour s'assurer qu'ils répondent à des normes de contrôle de qualité spécifiques avant d'être publiés sur le site Web public.
Dates principales de l'étude
Début de l'étude (Réel)
1 décembre 2021
Achèvement primaire (Anticipé)
1 mai 2023
Achèvement de l'étude (Anticipé)
1 mai 2023
Dates d'inscription aux études
Première soumission
8 mai 2022
Première soumission répondant aux critères de contrôle qualité
10 mai 2022
Première publication (Réel)
11 mai 2022
Mises à jour des dossiers d'étude
Dernière mise à jour publiée (Réel)
11 mai 2022
Dernière mise à jour soumise répondant aux critères de contrôle qualité
10 mai 2022
Dernière vérification
1 décembre 2021
Plus d'information
Termes liés à cette étude
Termes MeSH pertinents supplémentaires
- Maladies du système digestif
- Processus pathologiques
- Maladie
- Signes et symptômes digestifs
- Maladies gastro-intestinales
- Maladies du côlon, fonctionnelles
- Maladies du côlon
- Maladies intestinales
- Troubles de la motricité oesophagienne
- Troubles de la déglutition
- Maladies de l'oesophage
- Syndrome
- Syndrome de l'intestin irritable
- Diarrhée
- Reflux gastro-oesophagien
Autres numéros d'identification d'étude
- ZYYCXTD-C-202010
Plan pour les données individuelles des participants (IPD)
Prévoyez-vous de partager les données individuelles des participants (DPI) ?
NON
Informations sur les médicaments et les dispositifs, documents d'étude
Étudie un produit pharmaceutique réglementé par la FDA américaine
Non
Étudie un produit d'appareil réglementé par la FDA américaine
Non
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