Diarrhea-predominant irritable bowel syndrome (IBS)
Conditions
Interventions
Peifecare Group:None
Conba Intestinal Inflammation Ning Granule Group:None
Sponsors
Quzhou People's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. Voluntarily participate in this study and sign the "Informed Consent Form"; 2. Aged 18-65 years; 3. Clearly diagnosed with diarrhea-predominant irritable bowel syndrome (IBS-D) according to the Rome IV diagnostic criteria; 4. Patients have discontinued medications that violate the protocol for abdominal symptoms or diarrhea during the pre-treatment phase; 5. Patients do not make any significant lifestyle changes that could affect diarrhea symptoms during the study visits (e.g., starting a new diet or changing their usual exercise routine); 6. Colonoscopy reports from domestic tertiary hospitals within the past two years are normal or abnormalities are considered clinically insignificant by the investigator, such as chronic colitis diagnosed due to congestion and edema, but without blood, erosion, or ulcers; and with colon polyps having a diameter of <=3 mm and fewer than 5 in number.
Exclusion criteria
Exclusion criteria: 1. Organic diseases of the intestinal tract, such as colorectal cancer, inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, lactose intolerance, or other organic diseases; 2. History of abdominal or pelvic surgery, such as cholecystectomy (patients who have undergone appendectomy or cesarean section without intestinal complications such as intestinal obstruction, and those who have undergone endoscopic treatment for intestinal polyps are excluded); 3. Chronic pancreatitis, tumors, peptic ulcer, tuberculous peritonitis, cirrhosis, and other non-intestinal digestive system diseases (patients diagnosed with chronic cholecystitis by ultrasound can be included if they do not have typical biliary colic); 4. Abnormal routine stool results: fecal occult blood () or white blood cells (); 5. Severe systemic diseases in other organs, including serious lesions of the heart, brain, lungs, kidneys, immune regulatory diseases, metabolic diseases (diabetes, hyperthyroidism, or hypothyroidism), malignant tumors, or reproductive system diseases such as ovarian cysts, endometriosis, etc.; 6. Unclear diagnosis or multiple comorbidities; 7. Inability to discontinue concomitant medications affecting gastrointestinal motility and function during the trial, such as antibiotics, intestinal probiotics, proton pump inhibitors, etc.; 8. Pregnant or breastfeeding patients; 9. Patients currently participating in or having completed other clinical trials within the last 3 months; 10. Patients who have taken medications for treating IBS within 2 weeks prior to enrollment; 11. Patients with allergies or who are allergic to the study drug; 12. Other reasons deemed by the investigator that make the patient unsuitable for enrollment.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| IBS-SSS scale score;Clinical efficacy in patients with IBS-D; | — |
Secondary
| Measure | Time frame |
|---|---|
| Adverse event (AE) incidence;Quality of life scores of study subjects;Anxiety and depression score; | — |
Countries
China
Contacts
Public ContactJi Weiping
Quzhou People's Hospital
Outcome results
None listed