Functional dyspepsia overlapping gastroesophageal reflux disease
Conditions
Interventions
Control group:Placebo
Treatment group:Chaipu Shuwe Granules
Sponsors
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: (1) Meet the diagnostic criteria of Western medicine and the syndrome differentiation criteria of Traditional Chinese Medicine; (2) Aged 18-70 years regardless of gender; (3) No use of medications that may affect the study results (such as prokinetic agents acid-suppressing drugs etc.) within 2 weeks prior to enrollment; (4) Negative for Helicobacter pylori as confirmed by 13C or 14C breath test or endoscopic pathological examination within 6 months prior to enrollment; (5) Voluntary participation in this clinical study and signing of the informed consent form. (5) Negative for H. pylori by 13C or 14C breath test or endoscopic pathology within 6 months before enrollment; (6) Volunteer to participate in this clinical study and sign an informed consent form.
Exclusion criteria
Exclusion criteria: (1) Presence of gastroduodenal ulcers reflux esophagitis (Grade B or higher) Barrett's esophagus pyloric obstruction gastrointestinal tumors gastrointestinal tuberculosis pancreatobiliary diseases or other organic digestive diseases confirmed by gastroscopy within the past 6 months; (2) History of major gastrointestinal surgery (e.g. esophageal or gastric resection); (3) Structural abnormalities of the digestive tract or other organic diseases that may cause secondary reflux or dyspepsia (e.g. other types of esophagitis hiatal hernia achalasia diabetic gastroparesis heterotopic gastric mucosa connective tissue disorders etc.); (4) Women who are planning pregnancy currently pregnant or breastfeeding; (5) Individuals classified as legally disabled or those with severe mental emotional or behavioral disorders; (6) Severe primary cardiovascular cerebrovascular hepatic renal endocrine or hematologic diseases or other life-threatening conditions; (7) Allergy to the study medication or a history of drug-induced liver injury caused by traditional Chinese medicine; (8) Participation in other clinical trials within the past 4 weeks or concurrent enrollment in another clinical trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Total symptom score of FD overlapping with GERD;Reflux Disease Questionnaire (RDQ) score; | — |
Secondary
| Measure | Time frame |
|---|---|
| Self-Rating Depression Scale (SDS);Traditionl Chinese Medicine Syndrome Points;Self-Rating Anxiety Scale (SAS);SF-36 Quality of Life Questionnaire;Patient-Reported Clinical Outcome Evaluation Scale (PRO) Score for Chronic Gastrointestinal Disease; | — |
Countries
China
Contacts
Public ContactLing Jianghong
Shuguang Hospital Affiliated to Shanghai University of Traditional Chinese Medicine
Outcome results
None listed