IndigestionNCT06755671
A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
An observational study of Indigestion and Dyspepsia, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.
Trial 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. Read more about this study
- Who is it for?
- Ages 18 to 75 years
- Conditions the study is for
- Indigestion, Dyspepsia, Bloating
- What is being tested?
- Danning Tablet
- Type of treatment
- Pill or oral medicine
- How many people
- 4,500 participants
- Where
- 1 siteChina
- Study dates
- 30 Apr 2025to 30 Jun 2027
- Phase
- Observational
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 75 years
- All sexes
- No healthy volunteers
- Adult, Older adult
Study population: Patients with dyspepsia symptoms taking Danning Tablets
Who may be able to join
- 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
Who cannot join
- 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 locations and contacts
1 site in 1 country. Contact the study team or a site near you to ask about taking part.
China1 site, 1 recruiting
- Recruiting
The Second Affiliated Hospital Zhejiang University School of Medicine
Hangzhou, Zhejiang, 310009
Jianting CAI, Doctor of Medicine, +86 13805716757, jtcai6757@163.com
Litao JIA, Doctor of Medicine, +86 13958158234, jialitao@zju.edu.cn
About this study
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:
Read more
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.
- Conditions
- Indigestion, Dyspepsia, Bloating, Loss of Appetite, Reflux Acid, Constipation
- Being tested
- Danning Tablet
- Keywords
- Danning Tablets, dyspepsia, indigestion, observational study, real world study
- Medical subject headings
- Dyspepsia, Anorexia, Gastroesophageal Reflux, Constipation, Abdominal Pain
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
Danning TabletDrug
Danning Tablet is the only exposure in this observational study.
| Study group | Role | What they receive |
|---|---|---|
| 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. Receives: Drug: Danning Tablet |
What is being measured
The primary outcome is the main question the study is designed to answer.
Dyspepsia symptoms responder rate post treatment
A responder status is defined as patients reaching both a decrease of at least 50% regarding the Gastrointestinal Symptom Rating Scale (GSRS) score, and either symptom-free or markedly improved in the Global Patient Assessment (GPA) .
GSRS consists of 15 items for assessment of gastrointestinal symptoms. The 15 items include five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Each item is rated on a 7-point Likert scale. The reliability and validity of the GSRS are well-documented. GSRS can be self-administered in approximately 3~5 minutes.
The GPA asks patients the question "Please rate the strength of your upper abdominal complaints in the past 14 days. Please select how much they have changed compared to the condition at the onset of treatment: symptom-free, markedly improved, slightly improved, unchanged, worse".
Measured: From enrollment to the end of 4 weeks post enrollment
Secondary outcomes (5)
GPA responder rate
A responder status is defined as patients reaching either symptom-free or markedly improved in the GPA.
Measured: From enrollment to the end of 2 weeks and 4 weeks post enrollment
GSRS score responder rate
A responder status is defined as patients reaching a decrease of at least 50% regarding the GSRS score.
Measured: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Abdominal pain rating
Abdominal pain rating is defined as the multiplication of symptom frequency and severity rates. Abdominal pain frequency and severity are recorded in patient diary card. Symptom frequency is rated on a 5-point Likert scale. Symptom severity is rated through Visual Analogue Scale (VAS).
Measured: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Quality of Life assessment through EQ-5D-5L
TheEuroQol 5 Dimension 5-level (EQ-5D-5L) is a self-report survey that measures quality of life across 5 domains: mobility, self-care, usual activities, pain/discomfort, and anxiety/depression. Each dimension has 5 levels: no problems, slight problems, moderate problems, severe problems and extreme problems.
Measured: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Adverse event rate
Measured: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted1 Jan 2025
- Study start30 Apr 2025
- Primary completion30 Jun 2027 (estimated)
- Study completion30 Jun 2027 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for IndigestionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Prospective
- Enrolment
- 4,500 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals Limited
- Sponsor type
- Industry (pharma, biotech, devices)
- Responsible party
- Sponsor
- Investigators
- Jianting CAI, Doctor of Medicine, Principal investigator, Second Affiliated Hospital, Zhejiang University, School of Medicine
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06755671
- Sponsor's protocol ID
- CCPE202401
- Status last verified
- Dec 2024
- First submitted
- 24 Dec 2024
- Last updated
- 14 May 2025
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
- Individual data sharing
- No: The investigators have decided not to share IPD for confidentiality purpose. Yet IPD may be shared upon reasonable request on a one to one basis.
Study at a glance
From the registry record, last updated by the sponsor on 14 May 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- A Prospective Multicentre Real-world Assessment of the Efficacy of Danning Tablets in Alleviating Digestive Symptoms
- ClinicalTrials.gov ID
- NCT06755671
- Acronym / sponsor ID
- CCPE202401
- Conditions
- Indigestion, Dyspepsia, Bloating, Loss of Appetite, Reflux Acid, Constipation
- Keywords
- Danning Tablets, dyspepsia, indigestion, observational study, real world study
- Study type
- Observational
- Recruitment status
- Recruiting
- Enrolment
- 4,500 participants (estimated)
- Lead sponsor
- Shanghai Hutchison Pharmaceuticals LimitedIndustry (pharma, biotech, devices)
- Collaborators
- Second Affiliated Hospital, Zhejiang University, School of Medicine
- Study start
- 30 Apr 2025 (actual)
- Primary completion
- 30 Jun 2027 (estimated)
- Study completion
- 30 Jun 2027 (estimated)
- First posted
- 1 Jan 2025 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
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.
Study design
- Observational model
- Cohort
- Time perspective
- Prospective
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| Patients with dyspepsia symptoms taking Danning Tablets | – | Drug: Danning Tablet1. 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. |
Who may qualify
- Ages
- 18 to 75 years
- Sex
- All
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
- Study population
- Patients with dyspepsia symptoms taking Danning Tablets
Key inclusion criteria (4 listed)
- 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
Key exclusion criteria (7 listed)
- 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
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| Danning TabletDanning Tablet is the only exposure in this observational study. | Drug | Patients with dyspepsia symptoms taking Danning Tablets |
Primary outcome
Dyspepsia symptoms responder rate post treatment
Time frame: From enrollment to the end of 4 weeks post enrollment
A responder status is defined as patients reaching both a decrease of at least 50% regarding the Gastrointestinal Symptom Rating Scale (GSRS) score, and either symptom-free or markedly improved in the Global Patient Assessment (GPA) . GSRS consists of 15 items for assessment of gastrointestinal symptoms. The 15 items include five symptom clusters: Reflux, Abdominal pain, Indigestion, Diarrhoea and Constipation. Each item is rated on a 7-point Likert scale. The reliability and validity of the GSRS are well-documented. GSRS can be self-administered in approximately 3~5 minutes. The GPA asks patients the question "Please rate the strength of your upper abdominal complaints in the past 14 days. Please select how much they have changed compared to the condition at the onset of treatment: symptom-free, markedly improved, slightly improved, unchanged, worse".
5 secondary outcomes
GPA responder rate
Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
GSRS score responder rate
Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Abdominal pain rating
Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Quality of Life assessment through EQ-5D-5L
Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Adverse event rate
Time frame: From enrollment to the end of 2 weeks and 4 weeks post enrollment
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 14 May 2025.
- Individual participant dataSharing planned: No. The investigators have decided not to share IPD for confidentiality purpose. Yet IPD may be shared upon reasonable request on a one to one basis.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part.
Jianting CAI, Doctor of Medicine principal investigator
Second Affiliated Hospital, Zhejiang University, School of Medicine
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Indigestion and Dyspepsia, run by Shanghai Hutchison Pharmaceuticals Limited at 1 site in China.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 7 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: looking for participants now, as of the sponsor's last update on 14 May 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in China. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
Contact Yichen GAO, Master of Pharmacy (+86 13818076897, gaoyichen@shpl.com.cn), or a site near the patient. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Dyspepsia symptoms responder rate post treatment (time frame: From enrollment to the end of 4 weeks post enrollment). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 14 May 2025.