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

NCT ID: NCT06755671

Last Updated: 2025-05-14

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

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Recruitment Status

RECRUITING

Total Enrollment

4500 participants

Study Classification

OBSERVATIONAL

Study Start Date

2025-04-30

Study Completion Date

2027-06-30

Brief Summary

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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.

Detailed Description

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Conditions

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

Study Design

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Observational Model Type

COHORT

Study Time Perspective

PROSPECTIVE

Study Groups

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Patients with dyspepsia symptoms taking Danning Tablets

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.

Danning Tablet

Intervention Type DRUG

Danning Tablet is the only exposure in this observational study.

Interventions

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Danning Tablet

Danning Tablet is the only exposure in this observational study.

Intervention Type DRUG

Eligibility Criteria

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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
Minimum Eligible Age

18 Years

Maximum Eligible Age

75 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

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Second Affiliated Hospital, School of Medicine, Zhejiang University

OTHER

Sponsor Role collaborator

Shanghai Hutchison Pharmaceuticals Limited

INDUSTRY

Sponsor Role lead

Responsible Party

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Responsibility Role SPONSOR

Principal Investigators

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Jianting CAI, Doctor of Medicine

Role: PRINCIPAL_INVESTIGATOR

Second Affiliated Hospital, School of Medicine, Zhejiang University

Locations

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The Second Affiliated Hospital Zhejiang University School of Medicine

Hangzhou, Zhejiang, China

Site Status RECRUITING

Countries

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China

Central Contacts

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Yichen GAO, Master of Pharmacy

Role: CONTACT

+86 13818076897

Litao JIA, Doctor of Medicine

Role: CONTACT

+86 13958158234

Facility Contacts

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Jianting CAI, Doctor of Medicine

Role: primary

+86 13805716757

Litao JIA, Doctor of Medicine

Role: backup

+86 13958158234

Other Identifiers

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CCPE202401

Identifier Type: -

Identifier Source: org_study_id

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