Chronic Constipation
Conditions
Interventions
lactulose: lactulose
Lactulose combined with Medilac:Lactulose combined with Medilac
Sponsors
Union Hospital Affilated to Tongji Medical College of Huazhong Universsity of Science andTechnology
Eligibility
Sex/Gender
All
Age
18 Years to 65 Years
Inclusion criteria
Inclusion criteria: 1. The patient participated voluntarily and signed the informed consent; 2. Aged 18-65 years; 3. The Roman IV diagnostic criteria clearly identified functional constipation; 4. Patients in the screening period (i.e., the 14±3 days prior to the start of the treatment phase) completed symptom logging for at least 10 days; 5. Patients should stop taking drugs that violate the regimen for constipation in the pre-screening stage; 6. During the visit, the patient does not make any significant changes in lifestyle that may affect the symptoms of constipation (e.g. starting a new diet or changing the usual exercise pattern); 7. Abnormal results reported by colonoscopy in domestic hospitals above grade III within two years were normal or considered by researchers to have no clinical significance, such as chronic colitis diagnosed by hyperemia and edema, but no erosion ulcer, colonic polyps with diameter less than 3mm and numbers less than 5.
Exclusion criteria
Exclusion criteria: 1. Organic intestinal diseases, such as inflammatory bowel disease, intestinal tuberculosis, malabsorption syndrome, CD, lactose intolerance or other organic diseases; 2. Previous history of abdominal and pelvic surgery, such as cholecystectomy (except for appendectomy, cesarean section without intestinal complications such as intestinal obstruction, and endoscopic treatment of intestinal polyps); 3. Parenteral diseases of the digestive system, such as chronic pancreatitis, tumor, peptic ulcer, tuberculous peritonitis, chronic liver disease, liver cirrhosis, etc. (patients with chronic cholecystitis diagnosed by B-mode ultrasound can be included if they do not have typical bile colic); 4. Abnormal results of routine stool: fecal occult blood (+) or red blood cells (+) or white blood cells (+); 5. Other systemic diseases, including serious lesions in the heart, lung, kidney and other important organs, immunomodulatory diseases, metabolic diseases (diabetes, hyperthyroidism or hypothyroidism) or malignant tumors, and reproductive diseases such as ovarian cysts and endometriosis; 6. Warning symptoms (such as abdominal pain at night, weight loss, etc.) before screening; 7. Person who has A history of drug abuse or alcohol abuse (substances or drug use caused by the abnormal state of adaptation, which can lead to clinical pathology, in 12 months at least one performance: a. Repeated use of drugs or alcohol cause work, school or family to breach or failure, b. many times in the body of the danger of certain occasions to use drugs or alcohol, c. has the legal issues related to drug or alcohol use, d. though due to drugs or alcohol bring social or interpersonal relationship problem, still continue to use the material), and this drug allergies; 8. In the test, it is impossible to stop the concomitant drugs that affect gastrointestinal movement and function, such as antibiotics, intestinal microecological agents, proton pump inhibitors, etc.; 9. Women who are pregnant or breastfeeding or who plan to become pregnant during the course of the trial; 10. Less than 3 months after participation in or completion of other clinical trials; 11. Other researchers said it was not suitable for the candidates.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Defecation frequency;Fecal character;intestinal flora;Enterodynamic analysis; | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of overall symptom remission;abdominal discomfort;time in toilet;The endless feeling of defecation;defecate need assistance;Unsuccessful times of defecation per day;A feeling of bowel obstruction or obstruction;HAMD, HAMA, PAC-QOL PAC-SYM; | — |
Countries
China
Contacts
Public ContactShi Liu
Union Hospital Affiliated with Tongji Medical College of Huazhong University of Science and Technology
Outcome results
None listed