A multicenter, randomized, controlled, trial for efficacy of Chang-Yan-Ning granules in the treatment of functional diarrhea (FDi) and diarrhea-predominant irritable bowel syndrome (IBS-D)

Phase 4

• Conditions: functional diarrhea (FDi) and diarrhea-predominant irritable bowel syndrome (IBS-D)

• Registration Number: ITMCTR2000002901
• Lead Sponsor: Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Last Update Posted: 20 February 2023

Recruitment & Eligibility

• Status: Pending
• Sex: All
• Target Recruitment: Not specified

Inclusion Criteria

1. Informed consent signed by the patient;
2. Aged 18-65 years old;
3. The Rome IV diagnostic criteria clearly diagnosed as diarrheal irritable bowel syndrome (ibs-d) or functional diarrhea (FDi);
4. Discontinuation of contravention medications for abdominal symptoms or diarrhea in the pre-treatment phase;
5. No major changes in the patient's lifestyle during the visit that might affect the symptoms of diarrhoea (for example, starting a new diet, or changing normal exercise patterns);
6. Colonoscopy in domestic tertiary hospitals or above within two years reported normal results or abnormal results that researchers considered to be of no clinical significance, such as chronic colitis diagnosed due to congestion and edema, but no bleeding fecal erosion ulcer, colon polyps of less than 3mm in diameter and less than 5 in number.

Exclusion Criteria

1. Organic diseases of the intestine, such as inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, celiac disease, lactose intolerance or other organic diseases;
2. Previous history of abdominal and pelvic surgery, such as cholecystectomy, etc. (except for appendectomy, patients without intestinal complications such as intestinal obstruction after c-section, and endoscopic treatment of intestinal polyps);
3. Chronic pancreatitis, tumor, peptic ulcer, tuberculous peritonitis, cirrhosis and other diseases of the digestive system (patients with chronic cholecystitis diagnosed by b-mode ultrasound can be included if there is no typical gallbladder colic);
4. Abnormal stool routine results: occult blood in stool (+) or white blood cells (+);
5. Have other serious systemic diseases, including severe lesions of heart, lung, kidney and other important organs, immunoregulatory diseases, metabolic diseases (diabetes, hyperthyroidism or hypothyroidism) or malignant tumors, reproductive diseases such as ovarian cysts, endometriosis, etc.;
6. During the experiment, it is impossible to stop the concomitant drugs that affect the gastrointestinal movement and function, such as antibiotics, intestinal microecological preparations, proton pump inhibitors, etc.;
7. Pregnant or lactating patients;
8. Less than 3 months after participating in or completing other clinical trials;
9. Other researchers think not suitable for candidates.

Study & Design

• Study Type: Interventional study
• Study Design: Not specified

Primary Outcome Measures

Name	Time	Method
The total effective rate;