A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
For patients and families
In plain language
An automatic summary of structured registry data. It is an orientation aid, not a substitute for the official protocol or a physician assessment.
- What is being studied
- The protocol lists: Danning Tablet.
- Who it may be relevant to
- Registry conditions: Indigestion, Dyspepsia, Bloating, Loss of Appetite. Basic parameters: 18 years — 75 years · All.
- What needs checking
- Age, condition and sex are only basic indicators. Prior treatment, laboratory values and other mandatory requirements appear in the eligibility criteria below.
- Where it takes place
- China
- Next step
- Save the trial, show it to the treating physician, and confirm current recruitment with the study center. Costs, documents and travel →
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Overview
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.
Interventions
- Drug Danning Tablet
Danning Tablet is the only exposure in this observational study.
Primary outcome measures
- Dyspepsia symptoms responder rate post treatment [Time frame: From enrollment to the end of 4 weeks post enrollment]
Secondary outcome measures (5)
- GPA responder rate [Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- GSRS score responder rate [Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- Abdominal pain rating [Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- Quality of Life assessment through EQ-5D-5L [Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
- Adverse event rate [Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment]
Eligibility criteria
Inclusion criteria
- Patients between 18 and 75 years old
- Patients with at least one of the following symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation
- Patients already taking Danning Tablets as part of their regular medicine treatment for dyspepsia
- Patients agree to sign the informed consent form
Exclusion criteria
- Past history or comorbidity of malignant tumor
- Comorbidity of severe systemic condition including cardiovascular, cerebrovascular, renal and hematopoietic system diseases
- Past history of abdominal surgery (post pancreatic surgery, post subtotal gastrectomy; incomplete intestinal obstruction) or mental illness, mobility difficulty (e.g. long-term bed ridden)
- Comorbidity of any unstable chronic or acute disease,which may impact the evaluation of treatment efficacy as determined by the research physician
- Pregnancy or breastfeeding
- Participation in other clinical trials within the past 3 months
- Other circumstances determined as ineligible by the research physician
Criteria are shown verbatim from the registry (in English). Final eligibility is always assessed by the study center.
Healthy volunteers: No
Study design
- Observational model
- Cohort
Study locations
China · 1 center
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou
Identifiers
NCT: NCT06755671 · CCPE202401