Clinical trial NCT06755671: A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
Official title: A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
Study type: OBSERVATIONAL
Overall status: RECRUITING
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
Lead sponsor: Shanghai Hutchison Pharmaceuticals Limited
Sponsor class: INDUSTRY
Collaborators: name: Second Affiliated Hospital, School of Medicine, Zhejiang University
First posted: 2025-01-01
Enrollment: 4500
Sex: ALL
Minimum age (years): 18
Maximum age (years): 75
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Observational model: COHORT
Time perspective: PROSPECTIVE
Sampling method: NON_PROBABILITY_SAMPLE
Study population: Patients with dyspepsia symptoms taking Danning Tablets

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.


Eligibility 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

Primary outcomes:
measure: Dyspepsia symptoms responder rate post treatment
timeFrame: From enrollment to the end of 4 weeks post enrollment
Secondary outcomes:
measure: GPA responder rate
timeFrame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
measure: GSRS score responder rate
timeFrame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
measure: Abdominal pain rating
timeFrame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
measure: Quality of Life assessment through EQ-5D-5L
timeFrame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
measure: Adverse event rate
timeFrame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Other outcomes:
Locations:
city: Hangzhou
country: China
facility: The Second Affiliated Hospital Zhejiang University School of Medicine
state: Zhejiang
Study officials:
affiliation: Second Affiliated Hospital, School of Medicine, Zhejiang University
name: Jianting CAI, Doctor of Medicine
role: PRINCIPAL_INVESTIGATOR
References: