An observational study in Indigestion, Dyspepsia and Bloating, sponsored by Shanghai Hutchison Pharmaceuticals Limited. Recruiting at 1 site in China. Open to participants aged 18 Years to 75 Years. Per ClinicalTrials.gov, last updated 2025-05-14.
Sponsored by Shanghai Hutchison Pharmaceuticals Limited · Observational
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.
372 studies on the registry are indexed under Dyspepsia; 67 are open to participants now.
This study's planned enrollment of 4,500 is above the median of 200 across 62 observational studies indexed under Dyspepsia.
Browse Dyspepsia studies →Shanghai Hutchison Pharmaceuticals Limited is the lead sponsor of 8 studies on the registry; 3 are open to participants now.
Counted across the registry records on this site, refreshed daily.
Patients with dyspepsia symptoms taking Danning Tablets
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Underlined terms in the criteria open these too. Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Informed consent
Before you join, the study team explains what taking part involves — its purpose, what happens, the risks and possible benefits — and answers your questions, so you can decide freely. Consent is usually recorded on a form (the informed consent form, ICF) signed by you or, where the law allows, by someone legally authorised to decide for you.
You can keep asking questions during the study, you are told of new information that matters, and you can choose to leave at any time.
Explained by clinicaltrials.gg, not part of the registry record. The study team decides who can take part.
1. Patients between 18 and 75 years old; 2. Patients with at least one of the following symptoms: upper abdominal pain, bloating, loss of appetite, acid reflux or constipation; 3. Patients already taking Danning Tablets as part of their regular medicine treatment for dyspepsia; 4. Patients agree to sign the informed consent form.
Drug: Danning Tablet
Danning Tablet is the only exposure in this observational study.
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".
Time frame: From enrollment to the end of 4 weeks post enrollment
GPA responder rate
A responder status is defined as patients reaching either symptom-free or markedly improved in the GPA.
Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
GSRS score responder rate
A responder status is defined as patients reaching a decrease of at least 50% regarding the GSRS score.
Time frame: 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).
Time frame: 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.
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
Plan to share: No — 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.
No publications or documents are linked to this record.
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Contact study teamGet an email when the registry record changes — status, dates, results — or when someone posts here.
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Shanghai Hutchison Pharmaceuticals Limited