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| Name | Class |
|---|---|
| Second Affiliated Hospital, School of Medicine, Zhejiang University | OTHER |
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The goal of this observational study is to evaluate if Danning Tablets are effective in alleviating dyspepsia in patients with any of the following digestive symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation.
The main questions it aims to answer are:
How effective are Danning Tablets for patients with indigestion symptoms? What are the impact factors (e.g. severity of conditions, demographic features, dose and length of treatment etc.) of the efficacy of Danning Tablets for indigestion patients?
Participants already taking Danning Tablets as part of their regular medical care for indigestion will take questionnaires by the end of two weeks and four weeks respectively from the start of their treatment.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| Patients with dyspepsia symptoms taking Danning Tablets |
|
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Danning Tablet | Drug | Danning Tablet is the only exposure in this observational study. |
|
| Measure | Description | Time Frame |
|---|---|---|
| Dyspepsia symptoms responder rate post treatment | A responder status is defined as patients reaching both a decrease of at least 50% regarding the Gastrointestinal Symptom Rating Scale (GSRS) score, and either symptom-free or markedly improved in the Global Patient Assessment (GPA) . GSRS consists of 15 items for assessment of gastrointestinal symptoms. The 15 items include five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Each item is rated on a 7-point Likert scale. The reliability and validity of the GSRS are well-documented. GSRS can be self-administered in approximately 3~5 minutes. The GPA asks patients the question "Please rate the strength of your upper abdominal complaints in the past 14 days. Please select how much they have changed compared to the condition at the onset of treatment: symptom-free, markedly improved, slightly improved, unchanged, worse". | From enrollment to the end of 4 weeks post enrollment |
| Measure | Description | Time Frame |
|---|---|---|
| GPA responder rate | A responder status is defined as patients reaching either symptom-free or markedly improved in the GPA. | From enrollment to the end of 2 weeks and 4 weeks post enrollment |
| GSRS score responder rate |
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Inclusion Criteria:
Exclusion Criteria:
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Patients with dyspepsia symptoms taking Danning Tablets
| Name | Role | Phone | Extension | |
|---|---|---|---|---|
| Yichen GAO, Master of Pharmacy | Contact | +86 13818076897 | gaoyichen@shpl.com.cn | |
| Litao JIA, Doctor of Medicine | Contact | +86 13958158234 | jialitao@zju.edu.cn |
| Name | Affiliation | Role |
|---|---|---|
| Jianting CAI, Doctor of Medicine | Second Affiliated Hospital, School of Medicine, Zhejiang University | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| The Second Affiliated Hospital Zhejiang University School of Medicine | Recruiting | Hangzhou | Zhejiang | 310009 | China |
The investigators have decided not to share IPD for confidentiality purpose. Yet IPD may be shared upon reasonable request on a one to one basis.
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A responder status is defined as patients reaching a decrease of at least 50% regarding the GSRS score.
| From enrollment to the end of 2 weeks and 4 weeks post enrollment |
| Abdominal pain rating | Abdominal pain rating is defined as the multiplication of symptom frequency and severity rates. Abdominal pain frequency and severity are recorded in patient diary card. Symptom frequency is rated on a 5-point Likert scale. Symptom severity is rated through Visual Analogue Scale (VAS). | From enrollment to the end of 2 weeks and 4 weeks post enrollment |
| Quality of Life assessment through EQ-5D-5L | TheEuroQol 5 Dimension 5-level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems. | From enrollment to the end of 2 weeks and 4 weeks post enrollment |
| Adverse event rate | From enrollment to the end of 2 weeks and 4 weeks post enrollment |
| ID | Term |
|---|---|
| D004415 | Dyspepsia |
| D000855 | Anorexia |
| D005764 | Gastroesophageal Reflux |
| D003248 | Constipation |
| D015746 | Abdominal Pain |
| ID | Term |
|---|---|
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
| D015154 | Esophageal Motility Disorders |
| D003680 | Deglutition Disorders |
| D004935 | Esophageal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D010146 | Pain |
| D009461 | Neurologic Manifestations |
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