Functional dyspepsia with anxiety and depression disorders
Conditions
Interventions
Experimental group:Drug treatment: The experimental group was given the formula granules of Huanglian Wendan Decoction orally half an hour after breakfast and dinner for 4 consecutive weeks.
Control group:Drug treatment: The experimental group received a placebo containing 10% of the dosage of Huanglian Wendan Decoction, taken orally half an hour after breakfast and dinner for 4 consecuti
Sponsors
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: (1) Meeting the Western medical diagnostic criteria of FD and ADD as well as the TCM syndrome differentiation criteria; (2) Aged 18 to 65 years old; (3) No obvious organic diseases were found upon gastroscopy; (4) Voluntarily signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Those who do not meet the diagnostic criteria or have too many concurrent syndromes; (2) Those with HP infection; (3) Those with organic diseases causing dyspeptic symptoms, such as peptic ulcers, reflux esophagitis, bile reflux, erosive gastritis (grade 2 or above), atrophic gastritis (except for focal atrophy in the antrum), digestive tract tumors, etc.; those with pathological findings of gastric mucosa showing dysplasia, intestinal obstruction, liver, biliary and pancreatic diseases, etc.; (4) Those with systemic diseases that can cause digestive system symptoms, such as diabetes, renal insufficiency, connective tissue diseases, etc.; (5) Those with severe heart disease, liver cirrhosis, renal failure, malignant tumors and other life-threatening diseases; (6) Pregnant or lactating women; (7) Those with a history of alcohol or drug abuse; (8) Those who have participated in drug trials within the past 3 months; (9) Those currently taking medications that may affect the efficacy evaluation of the test drug (such as acid suppressants/antacids, non-steroidal anti-inflammatory drugs, anticholinergic drugs, glucocorticoids, antidepressants, etc.); (10) Those with a history of severe allergies or known allergies to the components of this drug; (11) Those with cognitive dysfunction, depression or other serious mental disorders; (12) Those with severe hearing or vision impairment, unable to complete the scale assessment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Symptom score in Traditional Chinese Medicine;Self-Rating Anxiety Scale;Nepean Dyspepsia Index;Self-Rating Depression Scale; | — |
Secondary
| Measure | Time frame |
|---|---|
| Microbiome sequencing;Transcriptome sequencing; | — |
Countries
China
Contacts
Public ContactXiaoyan Yan
Shandong University of Traditional Chinese Medicine Affiliated Hospital
Outcome results
None listed