Diarrheal irritable bowel syndrome
Conditions
Interventions
Experimental group:Shu-Gan Jie-Yu capsule + Trimebutine Maleate Tablets
control group:Simulation of Shu-Gan Jie-Yu capsule + Trimebutine Maleate Tablets
Sponsors
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Eligibility
Sex/Gender
All
Age
18 Years to 70 Years
Inclusion criteria
Inclusion criteria: 1) those who meet the diagnostic criteria for diarrhoea IBS in Rome IV; 2) those who meet the diagnostic criteria of TCM syndrome of liver depression and spleen deficiency; 3) Hamilton-17 depression scale score 8 to 19; 4) abdominal pain intensity: calculated by the most severe abdominal pain score in 1 day, the weekly average value is greater than or equal to 3 points [digital scale of grade 11 (0-10)]; Meanwhile, fecal traits: the fecal traits of Bristol fecal traits scale type 6 or 7 at least once every 2 days every week; 5) initial ibs-sss score > 75; 6) Aged 18 to 70 years old; 7) patients have informed consent and are willing to receive corresponding treatment; 8) living in the local area regularly can ensure treatment follow-up and reading ability.
Exclusion criteria
Exclusion criteria: 1) constipation type, mixed type and indeterminate IBS; 2) patients with heart, brain, liver, kidney, hematopoietic system and other serious diseases and malignant tumors, whose ALT, AST > normal range is 1.2 times of the upper limit, and Cr > normal limit; 3) organic diseases of the digestive system (such as chronic pancreatitis, etc.), or systemic diseases (such as hyperthyroidism, diabetes, chronic renal insufficiency, mental and nervous system diseases, etc.) that affect digestive tract dynamics; 4) patients with a history of abdominal surgery (except caesarean section and appendectomy); 5) patients with a history of drug allergy and severe food allergy used in the study; 6) pregnant and nursing women; 7) have a history of nervous system and mental illness; 8) subjects who are participating in other clinical trials.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| The integral change of the severity score of IBS;Comprehensive response rate of abdominal pain and stool traits;Hamilton depression scale;IBS-Quality Of Life;General impression scale; | — |
Primary
| Measure | Time frame |
|---|---|
| IBS-SSS; | — |
Countries
China
Contacts
Public ContactXudong Tang
Xiyuan Hospital, Chinese Academy of Traditional Chinese Medicine
Outcome results
None listed