Functional dyspepsia Digestive System
Conditions
Interventions
Patients were divided into one of the experimental groups (high-dose group, medium-dose group, low-dose group) or the control group. A central block randomization method was employed. Using the SAS st
Sponsors
Jiangxi Qingfeng Pharmaceutical Co., Ltd.
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Age =18 years and =65 years, regardless of gender 2. Voluntarily participate and sign the written informed consent form 3. Meet the diagnostic criteria for functional dyspepsia 4. Discontinuation of other prokinetic agents, gastroprotective agents, or acid-suppressing drugs for at least 4 weeks prior to enrollment
Exclusion criteria
Exclusion criteria: 1. Individuals with organic diseases such as esophagitis, atrophic gastritis, gastric and duodenal ulcers, erosions, bleeding, tumors, etc 2. Individuals with organic diseases of the liver, gallbladder, or pancreas 3. Individuals with diabetes, kidney disease, connective tissue disease, or psychiatric disorders 4. Individuals with severe primary diseases of the heart, brain, lungs, kidneys, hematopoietic system, or endocrine system 5. Individuals with a history of abdominal surgery 6. Individuals with renal insufficiency, with creatinine (Cr) levels above the upper limit of normal 7. Individuals with hepatic insufficiency, with AST and/or ALT levels 1.5 times the upper limit of normal 8. Pregnant women, those with pregnancy intentions, or women who are breastfeeding 9. Individuals with mental or legal disabilities 10. Individuals who have participated in other drug clinical trials within the 3 months prior to this trial
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The percentage of disappearance of the four Western medical symptoms of functional dyspepsia (postprandial fullness, early satiation, epigastric burning, and epigastric pain) after 4 weeks of medication. 1. Functional dyspepsia symptoms (postprandial fullness, early satiation, epigastric burning) are scored as follows: 0 points: No symptoms 1 point: Mild symptoms that do not affect daily life 2 points: Moderate symptoms that do not significantly affect daily life 3 points: Persistent symptoms that significantly affect daily life 2. For epigastric pain, the Visual Analog Scale (VAS) is used: A 10-cm straight line is employed, where the 0 cm end represents "no pain" and the 10 cm end represents "the most severe pain." Patients mark the point on the line that corresponds to their level of pain. | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastric emptying assessed using radionuclide imaging: for selected centers (West China Hospital of Sichuan University and Xiangya Hospital of Central South University), radionuclide imaging is used to assess gastric emptying function. The 2-hour gastric emptying rate and half-emptying time are observed. The test is conducted and recorded once before medication and once after 28 days of medication. The 2-hour gastric emptying rate and half-emptying time (radionuclide imaging) are compared between groups. | — |
Countries
China
Contacts
Public ContactTiancheng Qi
Outcome results
None listed