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

HUTCHMED

Status: Enrolling

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

Treatments: Drug: Danning Tablet

Study type: Observational

Funder types: Other; Industry

Identifiers

NCT06755671

CCPE202401

Details and patient eligibility

About

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.

Enrollment: 4,500 estimated patients

Sex: All

Ages: 18 to 75 years old

Volunteers: No Healthy Volunteers

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

Trial design

4,500 participants in 1 patient group

Patients with dyspepsia symptoms taking Danning Tablets

Description:

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.

Treatment:

Drug: Danning Tablet