Evaluating the effectiveness of Danning Tablets for digestive symptoms
A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
This study is testing if Danning Tablets can help people aged 18 to 75 feel better from digestive issues like indigestion and bloating while they are already using the medication.
Quick facts
| Study type | Observational |
|---|---|
| Enrollment | 4500 (estimated) |
| Ages | 18 Years to 75 Years |
| Sex | All |
| Sponsor | Shanghai Hutchison Pharmaceuticals Limited Industry-sponsored |
| Locations | 1 site (Hangzhou, Zhejiang) |
| Trial ID | NCT06755671 on ClinicalTrials.gov |
What this trial studies
This observational study aims to assess the efficacy of Danning Tablets in alleviating digestive symptoms such as indigestion, bloating, and acid reflux in patients already using the medication. Participants aged 18 to 75 will complete questionnaires at two and four weeks into their treatment to evaluate symptom relief and identify factors influencing effectiveness. The study focuses on real-world data to provide insights into the practical benefits of Danning Tablets for managing dyspepsia.
Who should consider this trial
Good fit: Ideal candidates are adults aged 18 to 75 who are currently taking Danning Tablets for digestive issues.
Not a fit: Patients with severe systemic conditions or a history of certain surgeries or mental illness may not benefit from this study.
Why it matters
Potential benefit: If successful, this study could provide evidence supporting the use of Danning Tablets as an effective treatment for digestive symptoms.
How similar studies have performed: While this approach is observational, similar studies evaluating real-world effectiveness of treatments have shown promising results.
Eligibility criteria
Show full inclusion / exclusion criteria
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
Where this trial is running
Hangzhou, Zhejiang
- The Second Affiliated Hospital Zhejiang University School of Medicine — Hangzhou, Zhejiang, China (Recruiting)
Study contacts
- Principal investigator: Jianting CAI, Doctor of Medicine — Second Affiliated Hospital, School of Medicine, Zhejiang University
- Study coordinator: Yichen GAO, Master of Pharmacy
- Email: gaoyichen@shpl.com.cn
- Phone: +86 13818076897
How to participate
- Review the eligibility criteria above with your treating physician.
- Visit the official trial page on ClinicalTrials.gov for the most current contact information and recruitment status.
- Contact the listed study coordinator or principal investigator to request pre-screening. Pre-screening is free and never obligates you to enroll.