Functional bloating
Conditions
Interventions
Control Group:Take Simo Decoction Placebo
Sponsors
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: Inclusion criteria: 1. Those who meet the Roman IV diagnostic criteria for functional abdominal distension; ? Recurrent abdominal distention and/or abdominal distention, averaging at least 1 day per week; Abdominal distention and/or abdominal distention are more prominent than other symptoms; ? Routine examination (including colonoscopy) found no evidence of organic, systemic or surrogate disease that could explain the above symptoms; ? Symptoms appeared for at least 6 months before diagnosis, and the above diagnostic criteria were met in the last 3 months; 2. Patients aged between 18 and 65 years (including endpoints), regardless of gender, were outpatients; 3. During the trial, the forbidden drugs that may affect the effectiveness evaluation of the test drugs, such as prokinetic drugs, digestive enzyme preparations, anticholinergic drugs, glucocorticoids, etc., can be stopped; 4. Those who voluntarily participated in the study and signed the informed consent; 5. VAS of major symptoms during the one-week initiation period
Exclusion criteria
Exclusion criteria: Exclusion criteria: 1. Patients with bowel cancer, inflammatory bowel disease, ischemic bowel disease, large colorectal polyp and other organic bowel diseases; 2. Patients with a history of gastrointestinal surgery; 3. Patients with serious primary diseases of cardiovascular, cerebrovascular, liver, kidney and hematopoietic system (ALT, AST more than 2 times the upper limit of normal value), diabetes, thyroid dysfunction and other endocrine system diseases; 4. Chemical dyspepsia caused by cholecystitis, cholelithiasis and chronic pancreatitis; 5. Known allergic to the composition of the drug; 6. Women who are pregnant or breastfeeding or have a birth plan within the last 3 months 7. Long-term alcoholism, drug dependence, mental illness; 8. Have received or are receiving other drug clinical investigators within 3 months prior to participating in this study; 9. The investigator considers it unsuitable to participate in clinical research.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Gastrointestinal Symptom Rating Scale;Evaluation of individual symptoms of functional abdominal distension;Visual analog rating Scale;Hospital Anxiety depression Scale score;Overall disease response rate; | — |
Countries
China
Contacts
Public ContactXudong Tang
Xiyuan Hospital, China Academy of Chinese Medical Sciences
Outcome results
None listed