Functional Dyspepsia (FD)
Conditions
Interventions
experimental group:The investigational product shall be taken orally with water, one sachet per dose, twice daily, for 12 consecutive weeks.
placebo-controlled:The placebo shall be taken orally after reconstitution with water, one sachet per dose, twice daily, for 12 consecutive weeks.
Sponsors
Soochow University
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: [1] Aged 18–65 years, male or female; [2] Presence of persistent or intermittent upper abdominal discomfort, bloating, postprandial fullness, or early satiation for at least 3 months (meeting the Rome IV diagnostic criteria for functional dyspepsia); [3] Signed informed consent.
Exclusion criteria
Exclusion criteria: [1] Use of gastric acid suppressants (H2 receptor antagonists or proton pump inhibitors), prokinetic agents (e.g., mosapride or domperidone), or gastric mucosal protectants (e.g., teprenone, sucralfate, gefarnate, glutamine, rebamipide, bismuth agents, etc.) within the 2 weeks prior to screening; [2] Presence of definite organic gastrointestinal diseases (e.g., active peptic ulcer, inflammatory bowel disease, gastrointestinal malignancy, etc.); [3] Pregnant or lactating women, or those planning to become pregnant during the trial period; [4] Severe cardiac, hepatic, or renal insufficiency; malignant tumors; or psychiatric disorders; [5] Known or suspected allergy to the investigational product or its excipients; [6] Participation in another clinical trial of any investigational drug within 1 month prior to screening enrollment; [7] Any other condition that, in the investigator's opinion, indicates poor compliance or makes the subject unsuitable for participation in this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| GSRS (Gastrointestinal Symptom Rating Scale) total score;Gastric Mucosal Symptom Observation Score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Gastroscopy Score;Degree of Subxiphoid Tenderness;Fecal Calprotectin Level;Serum Pepsinogen I/II Ratio;Blood Lipopolysaccharide (LPS);Stool Form and Frequency;Quality of Life Questionnaire; | — |
Countries
China
Contacts
Public ContactGuochong Chen
Soochow University
Outcome results
None listed