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.

Study Overview

• Status: Recruiting
• Conditions: Functional Dyspepsia; Dyspepsia; Constipation; Reflux Acid; Loss of Appetite; Bloating; Indigestion; Upper Abdominal Pain
• Intervention / Treatment: Drug: Danning Tablet

• Study Type: Observational
• Enrollment (Estimated): 4500

Contacts and Locations

• Study Contact: Name: Yichen GAO, Master of Pharmacy; Phone Number: +86 13818076897; Email: gaoyichen@shpl.com.cn
• Study Contact Backup: Name: Litao JIA, Doctor of Medicine; Phone Number: +86 13958158234; Email: jialitao@zju.edu.cn

Study Locations

• China
  • Zhejiang
    • Hangzhou, Zhejiang, China, 310009
      • Recruiting
      • the Second Affiliated Hospital Zhejiang University School of Medicine
      • Contact: Litao JIA, Doctor of Medicine; Phone Number: +86 13958158234; Email: jialitao@zju.edu.cn
      • Contact: Jianting CAI, Doctor of Medicine; Phone Number: +86 13805716757; Email: jtcai6757@163.com

Participation Criteria

Eligibility Criteria

• Ages Eligible for Study: Adult; Older Adult
• Accepts Healthy Volunteers: No

• Sampling Method: Non-Probability Sample

Study Population

Patients with dyspepsia symptoms taking Danning Tablets

Description

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

Study Plan

How is the study designed?

Number of groups / cohorts

1

Cohorts and Interventions

Group / Cohort	Intervention / Treatment
Patients with dyspepsia symptoms taking Danning Tablets; 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.	Drug: Danning Tablet; Danning Tablet is the only exposure in this observational study.

What is the study measuring?

Primary Outcome Measures

Outcome Measure	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

Secondary Outcome Measures

Outcome Measure	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	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

Collaborators and Investigators

• Sponsor: Shanghai Hutchison Pharmaceuticals Limited
• Collaborators: Second Affiliated Hospital, School of Medicine, Zhejiang University
• Investigators: Principal Investigator: Jianting CAI, Doctor of Medicine, Second Affiliated Hospital, School of Medicine, Zhejiang University

Study record dates

Study Major Dates

• Study Start (Actual): April 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027

Study Registration Dates

• First Submitted: December 24, 2024
• First Submitted That Met QC Criteria: December 24, 2024
• First Posted (Actual): January 1, 2025

Study Record Updates

• Last Update Posted (Actual): May 14, 2025
• Last Update Submitted That Met QC Criteria: May 13, 2025
• Last Verified: December 1, 2024

More Information

Terms related to this study

• Keywords: observational study; dyspepsia; real world study; indigestion; Danning Tablets
• Additional Relevant MeSH Terms: Pain; Neurologic Manifestations; Signs and Symptoms, Digestive; Abdominal Pain; Constipation; Dyspepsia; Anorexia
• Other Study ID Numbers: CCPE202401

Plan for Individual participant data (IPD)

• Plan to Share Individual Participant Data (IPD)?: NO
• IPD Plan Description: 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.

Drug and device information, study documents

• Studies a U.S. FDA-regulated drug product: No
• Studies a U.S. FDA-regulated device product: No