irritable bowel syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Patients meeting diagnosis of IBS-D (Rome IV); (2) Patients providing signed informed consent; (3) Male or female aged 18 to 75 years; (4) Patients reporting a Irritable Bowel Syndromes Symptom Severity Score (IBS-SSS) of >75.
Exclusion criteria
Exclusion criteria: (1) Patients with alarm symptoms; (2) Patients with history or current evidence of inflammatory bowel disease; (3) Patients with history or current evidence of concurrent enteric infection, hyperthyroidism or other diseases causing diarrhea and abdominal pain; (4) Patients who report a anxiety score of > 50 on Self-rating Anxiety Scale (SAS) or a depression score of > 53 on Self-rating Depression Scale (SDS), or patients with other psychiatric disorders; (5) Patients with a history of gastrointestinal surgery causing similar syndromes with IBS; (6) Patients who are unable or unwilling to stop taking medication affecting the assessments of experimental drug efficacy and safety; (7) Patients who are pregnancy, breast feeding, or plan to conceive within 3 months; (8) Patients with concurrent serious diseases, such as cancer, serious cardiovascular, respiratory, hepatic, renal, or neurological disease; (9) Patients who are participating or have participated in another clinical trial within the previous 3 months; (10) Patients who are in researchers opinion unsuitable for this trial.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| AR; | — |
Secondary
| Measure | Time frame |
|---|---|
| severity of abdominal pain;severity of abdominal discomfort;severity of abdominal distension;stool frequency;stool consistency;urgency;feelings of incomplete evacuation;mucus;IBS-SSS;IBS-QOL;HADS; | — |
Countries
China
Contacts
The Second Affiliated Hospital of Guangzhou University of Chinese Medicine