Irritable Bowel Syndrome
Conditions
Interventions
Sponsors
Eligibility
Inclusion criteria
Inclusion criteria: (1) Meeting the diagnostic criteria for IBS in the Consensus on Integrative Medicine Diagnosis and Treatment of Irritable Bowel Syndrome (2017) with the TCM syndrome type being cold-heat mixed syndrome; (2) Exclusion of intestinal organic lesions by colonoscopy; (3) Aged 18–65 years; (4) No administration of IBS treatment drugs in the past month; (5) No history of abdominal surgery; (6) Hamilton Depression Scale score =7 and =17 Hamilton Anxiety Scale score =7 and =14; (7) Informed about the study and signed the informed consent form.
Exclusion criteria
Exclusion criteria: (1) Aged 65 years; (2) Constipation-predominant IBS mixed IBS or unsubtyped IBS; (3) Diarrhea caused by tumors bacterial/viral infections poisoning etc.; (4) Participation in other clinical trials or allergy/intolerance to the study drugs; (5) Use of drugs affecting intestinal function or pain within the past month; (6) Pregnant or lactating women; (7) Comorbid mental disorders inflammatory bowel disease or severe cardiovascular hepatic renal or cerebrovascular diseases; (8) Refusal of traditional Chinese medicine.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Serum levels of CRH, ACTH, and cortisol;Serum brain-gut peptide levels (VIP 5-HT SP BDNF); | — |
Secondary
| Measure | Time frame |
|---|---|
| Traditional Chinese Medicine (TCM) syndrome scores;Overall symptom evaluation;Single symptom evaluation; | — |
Countries
China
Contacts
Affiliated Hospital of Shanxi University of Chinese Medicine