Skip to content

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)

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)

Status
Active, not recruiting
Phases
Phase 4
Study type
Interventional
Source
ChiCTR
Registry ID
ChiCTR2000028830
Enrollment
Unknown
Registered
2020-01-05
Start date
2020-01-13
Completion date
Unknown
Last updated
2020-01-13

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

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

Interventions

Sponsors

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University
Lead Sponsor

Eligibility

Sex/Gender
All
Age
18 Years to 65 Years

Inclusion criteria

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

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.

Design outcomes

Primary

MeasureTime frame
The total effective rate;

Countries

China

Contacts

Public ContactChen Shujie

Sir Run Run Shaw Hospital, College of Medicine, Zhejiang University

4094108@qq.com+86 13867489890

Outcome results

None listed

Source: ChiCTR (via WHO ICTRP) · Data processed: Feb 13, 2026