IBS-D
Conditions
Interventions
Placebo + test group:Drug
Sponsors
Union Hospital affiliated to Tongji Medical College of Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. Meet the diagnostic criteria for diarrheal irritable bowel syndrome (IBS-D) in Rome IV; 2. Aged between 18 and 65 years; 3. IBS-SSS total score >=75 points; 4. The selection criteria for the baseline period must meet the following requirements: During the placebo introduction period, the weekly average of the NRS score of the most severe abdominal pain intensity per day >=3 points; During the introduction period of placebo >=2 days, at least once a day stool characteristics of Bristol type 6 or 7; Accumulated emergency medication (pinaverium bromide tablets and/or montmorillonite powder) during the introduction period =5 days; 5. Colonoscopy in a tertiary hospital within 2 years before screening Check and keep the check report. At the same time, the interval between colonoscopy check and ICF signing >=28 days; 6. Able to understand and abide by the test procedure, participate in the test voluntarily and sign the informed consent.
Exclusion criteria
Exclusion criteria: 1. Subjects currently suffering from constipation, mixed or indeterminate IBS; 2. Subjects with gastrointestinal alarm symptoms within 14 days before screening, Such as blood in the stool, fecal occult blood test positive, anemia, abdominal mass, ascites, fever, weight loss, family history of colorectal cancer; 3. Those who have been diagnosed with organic diseases of the digestive system, such as inflammatory bowel disease, bowel Tuberculosis, intestinal polyps (except for polyps =half a month), intestinal diverticulum, intestinal tumors, etc., or are still combined with peptic ulcers, infectious diarrhea, etc.; 4. A clear diagnosis in the past People with diseases similar to irritable bowel syndrome, such as eosinophilic enteritis, microscopic colitis (including collagenous colitis and lymphocytic colitis), lactose intolerance, malabsorption syndrome, etc.; 5. Those who have been clearly diagnosed with non-intestinal digestive system diseases, such as tuberculous peritonitis, gallstones, cirrhosis, chronic pancreatitis, etc.; 6. Those who have been clearly diagnosed with diseases that affect digestive tract function, such as hyperthyroidism or hypothyroidism (Except those who have recovered), endometriosis, chronic renal insufficiency, autoimmune disease, diabetes, neurological (such as anorexia nervosa, etc.) or mental system disease (such as severe depression or severe anxiety), etc.; 7. Previous history of digestive system surgery (except for appendectomy and intestinal polypectomy), such as cholecystectomy, etc.; 8. Previously suffering from severe heart and cerebrovascular diseases, liver and kidney function significantly abnormal (alanine amino transfer Enzyme or aspartate aminotransferase>1.5 ULN, or total bilirubin>1.5 ULN, or Cr exceeds the upper limit of normal), hematopoietic diseases, and tumors; 9. From signing ICF to completion During the V5 visit or withdrawal from the trial visit, drugs that affect gastrointestinal motility and function cannot be stopped or planned, such as prokinetics, anticholinergics, calcium channel blockers, 5-HT3 receptor antagonists, Antidiarrheals, antacids, antidepressants, anti-anxiety drugs, intestinal flora regulators, antibiotics, etc.; 10. People with allergies or allergic to the components of the test drug; 11. Suspected or confirmed history of alcohol or drug abuse; 12. Have received or are receiving treatment with any other experimental drugs or test devices in the past 3 months; 13. Have a serious mental illness or language barrier, cannot fully understand this study and sign an informed consent; 14. Pregnancy or breastfeeding Female; 15. The male subjects partner or female subject plans to become pregnant during the trial period, or is unwilling to take reliable contraceptive measures for contraception within 4 weeks after signing the informed consent form to the last taking the trial drug; 16. The investigator believes Subjects have other conditions that are not suitable for participating in this study.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| The effective rate of improvement of abdominal pain and defecation traits in randomized controlled trial subjects after treatment.; | — |
Countries
China
Contacts
Public ContactXilin Peng
Diao Group Chengdu Pharmaceutical Co., Ltd.
Outcome results
None listed