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NCT Number: NCT06755671

A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms

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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Key information

Conditions

Indigestion Abdominal Pain Anorexia Bloating Constipation Deglutition Disorders Digestive System Diseases Dyspepsia Esophageal Diseases Esophageal Motility Disorders Functional Dyspepsia Gastroesophageal Reflux Gastrointestinal Diseases Loss of Appetite Neurologic Manifestations Pain Pathological Conditions, Signs and Symptoms Reflux Acid Signs and Symptoms Signs and Symptoms, Digestive Upper Abdominal Pain

Age range

18 year–75 year

Sex eligibility

All sexes

Study type

Observational

Primary location

Who can participate

Healthy volunteers accepted: No

Only the study team can determine whether someone qualifies for participation.

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

Treatment and study plan

Danning Tablet

Drug

Danning Tablet is the only exposure in this observational study.

Primary outcomes

  1. Dyspepsia symptoms responder rate post treatment

    Time frame: From enrollment to the end of 4 weeks post enrollment

    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".

Secondary outcomes

  1. GPA responder rate

    Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment

    A responder status is defined as patients reaching either symptom-free or markedly improved in the GPA.

  2. GSRS score responder rate

    Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment

    A responder status is defined as patients reaching a decrease of at least 50% regarding the GSRS score.

  3. Abdominal pain rating

    Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment

    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).

  4. Quality of Life assessment through EQ-5D-5L

    Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment

    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.

  5. Adverse event rate

    Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment

Study contacts

Contact information is provided by the study sponsor or research team.

Litao JIA, Doctor of Medicine

CONTACT

[email protected]

+86 13958158234

Yichen GAO, Master of Pharmacy

CONTACT

[email protected]

+86 13818076897

Sponsors and collaborators

Lead sponsor

Shanghai Hutchison Pharmaceuticals Limited

Industry

Collaborators

  • Second Affiliated Hospital, School of Medicine, Zhejiang University

Registry information

Important dates

Study start
2025
Primary completion
2027
Study completion
2027
First posted
Jan 1, 2025
Registry last updated
May 14, 2025

OpenTrials presents study information sourced from ClinicalTrials.gov. The official registry record should be consulted for the latest information.

View the official ClinicalTrials.gov record (opens in a new tab)

This listing is for discovery and informational purposes only. It is not medical advice, does not guarantee that a study is recruiting, and does not determine eligibility. Contact the study team and a qualified healthcare professional when considering participation.

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