Actively Recruiting
A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
Led by Shanghai Hutchison Pharmaceuticals Limited · Updated on 2025-05-14
4500
Participants Needed
1
Research Sites
N/A
Total Duration
On this page
Sponsors
S
Shanghai Hutchison Pharmaceuticals Limited
Lead Sponsor
S
Second Affiliated Hospital, School of Medicine, Zhejiang University
Collaborating Sponsor
AI-Summary
What this Trial Is About
This observational study aims to evaluate the effectiveness of Danning Tablets in relieving dyspepsia symptoms in patients who experience digestive issues such as upper abdominal pain, bloating, loss of appetite, acid reflux, or constipation. It seeks to understand how factors like symptom severity, patient demographics, dosage, and treatment duration influence the tablets' impact. The study is sponsored by Shanghai Hutchison Pharmaceuticals Limited and focuses on patients already using Danning Tablets in their regular care. Participants in this study are adults aged 18 to 75 who are currently taking Danning Tablets for indigestion symptoms as part of their regular treatment. The study involves collecting questionnaire responses at two and four weeks after starting their treatment to assess changes in symptoms and quality of life. There is no control group since this is an observational study of patients already taking the medication. Throughout the study, participants will complete assessments measuring the rate of symptom improvement, including dyspepsia symptom relief, gastrointestinal symptom rating scales, abdominal pain ratings, and quality of life using the EQ-5D-5L questionnaire. Adverse events are also monitored during the two- and four-week periods. The main outcome is the responder rate for dyspepsia symptoms at four weeks after enrollment, with all participation lasting up to four weeks.
CONDITIONS
Brief Title
A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
Who Can Participate
Eligibility Criteria
You may qualify if you...
- 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 will not qualify if you...
- 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
AI-Screening
AI-Powered Screening
Complete this quick 3-step screening to check your eligibility
Your Study Journey
Duration - 2 to 4 weeks
Participants are screened for eligibility to participate in the trial.
Duration - 4 weeks
Participants take Danning Tablets as part of their regular medicine treatment for dyspepsia.
1 baseline visit and 1 follow-up visit
Trial Site Locations
Total: 1 location
1
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, China, 310009
Actively Recruiting
Research Team
Y
Yichen GAO, Master of Pharmacy
L
Litao JIA, Doctor of Medicine
How is the study designed?
Study Type
OBSERVATIONAL
Masking
N/A
Allocation
N/A
Model
N/A
Primary Purpose
N/A
Number of Arms
1
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