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

NCT06755671 | Recruiting

• 1 other identifier: CCPE202401
• Study Type: observational
• Target: 4,500
• Locations: 1 country
• Sites: 1

Brief Summary

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.

Conditions

Indigestion; Dyspepsia; Bloating; Loss of Appetite; Reflux Acid; Constipation; Upper Abdominal Pain; Functional Dyspepsia

Keywords

Danning Tablets; dyspepsia; indigestion; observational study; real world study

Outcome Measures

Primary Outcomes (1)

• 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 Outcomes (5)

• GPA responder rate

  From enrollment to the end of 2 weeks and 4 weeks post enrollment

• GSRS score responder rate

  From enrollment to the end of 2 weeks and 4 weeks post enrollment

• Abdominal pain rating

  From enrollment to the end of 2 weeks and 4 weeks post enrollment

• Quality of Life assessment through EQ-5D-5L

  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

Study Arms (1)

Patients with dyspepsia symptoms taking Danning Tablets

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

Interventions

Danning Tablet DRUG

Danning Tablet is the only exposure in this observational study.

Patients with dyspepsia symptoms taking Danning Tablets

Eligibility Criteria

• Age: 18 Years - 75 Years
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)
• Sampling Method: Non-Probability Sample

Study Population

Patients with dyspepsia symptoms taking Danning Tablets

You may qualify if:

• 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

You may not qualify if:

• 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

Sponsors & Collaborators

• Shanghai Hutchison Pharmaceuticals Limited: lead
• Second Affiliated Hospital, School of Medicine, Zhejiang University: collaborator

Study Sites (1)

The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, 310009, China

RECRUITING

MeSH Terms

Conditions

Dyspepsia; Anorexia; Gastroesophageal Reflux; Constipation; Abdominal Pain

Condition Hierarchy (Ancestors)

Signs and Symptoms, Digestive; Signs and Symptoms; Pathological Conditions, Signs and Symptoms; Esophageal Motility Disorders; Deglutition Disorders; Esophageal Diseases; Gastrointestinal Diseases; Digestive System Diseases; Pain; Neurologic Manifestations

Study Officials

• Jianting CAI, Doctor of Medicine

  Second Affiliated Hospital, School of Medicine, Zhejiang University

  PRINCIPAL INVESTIGATOR

Central Study Contacts

Yichen GAO, Master of Pharmacy

CONTACT

+86 13818076897; gaoyichen@shpl.com.cn

Litao JIA, Doctor of Medicine

CONTACT

+86 13958158234; jialitao@zju.edu.cn

Study Design

• Study Type: observational
• Observational Model: COHORT
• Time Perspective: PROSPECTIVE
• Sponsor Type: INDUSTRY
• Responsible Party: SPONSOR

Study Record Dates

• First Submitted: December 24, 2024
• First Posted: January 1, 2025
• Study Start: April 30, 2025
• Primary Completion (Estimated): June 30, 2027
• Study Completion (Estimated): June 30, 2027
• Last Updated: May 14, 2025

Record last verified: 2024-12

Data Sharing

• IPD Sharing: Will not share

Locations

CN (1)