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

Last updated: May 13, 2025
Sponsor: Shanghai Hutchison Pharmaceuticals Limited
Overall Status: Active - Recruiting

Phase

N/A

Condition

Anorexia

Lactose Intolerance

Ulcerative Colitis (Pediatric)

Treatment

Danning Tablet

Clinical Study ID

NCT06755671
CCPE202401
  • Ages 18-75
  • All Genders

Study 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

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 treatmentfor dyspepsia

  • Patients agree to sign the informed consent form

Exclusion

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 subtotalgastrectomy; incomplete intestinal obstruction) or mental illness, mobilitydifficulty (e.g. long-term bed ridden)

  • Comorbidity of any unstable chronic or acute disease,which may impact the evaluationof 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

Study Design

Total Participants: 4500
Treatment Group(s): 1
Primary Treatment: Danning Tablet
Phase:
Study Start date:
April 30, 2025
Estimated Completion Date:
June 30, 2027

Connect with a study center

  • The Second Affiliated Hospital Zhejiang University School of Medicine

    Hangzhou, Zhejiang 310009
    China

    Active - Recruiting

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