Functional constipation
Conditions
Interventions
Functional Constipation:AGIROMC1-1 (TC) vs 8100-10 capsules w/24TC
Sponsors
Union Hospital, Tongji Medical College, Huazhong University of Science and Technology
Eligibility
Sex/Gender
All
Age
18 Years to 75 Years
Inclusion criteria
Inclusion criteria: Subjects must meet all the following inclusion criteria: 1. Aged 18 to 75 years; 2. Meet the diagnostic criteria for functional constipation in Roman IV, that is, the symptoms appear at least 6 months before diagnosis, and the following diagnostic criteria are met in the last 3 months, that is, 2 or more of the following must be included: (1) More than 25% of defecation is strenuous; (2) More than 25% of defecation was dry bulb feces or hard feces (Bristol feces traits Scale type 1-2). (3) more than 25% of defecation is not enough; (4) More than 25% of defecation have a sense of anal obstruction/blockage; (5) More than 25% of defecation requires manual assistance (e.g. finger assisted defecation, pelvic floor support) (6) Spontaneous defecation less than 3 times per week; Loose stool is rare when laxative is not used and does not meet the diagnostic criteria for irritable bowel syndrome. 3. The subject's constipation is functional, so the colonoscopy results of the third grade a hospital in the past 2 years should be provided to exclude organic lesions mentioned in the second exclusion criteria; 4. Able and willing to comply with the taboos and restrictions specified in the scheme; 5. Subjects must be willing and able to fill in the questionnaire and diary; 6. Subjects can be followed up in accordance with the provisions in the test plan during the test period; 7. Subjects agree to use contraception during the study period; 8. The subject understands the purpose and procedure of the test and voluntarily participates in the test and voluntarily signs written informed consent.
Exclusion criteria
Exclusion criteria: Subjects who meet one or more of the following criteria shall be excluded: 1. Allergic to barium; 2. Organic lesions of the large intestine are known or suspected, i.e., obstruction, cancer, or inflammatory disease; 3. Stenosis, obstruction, diverticulum, perforation, bleeding and infection of the digestive tract are known or suspected; 4. Subjects have severe and clinically uncontrolled cardiovascular, pulmonary, liver, neurological or psychiatric diseases (including alcohol or drug abuse), cancer or AIDS, gastrointestinal or endocrine diseases; 5. Previous operation to change the structure of digestive tract (except appendectomy); 6. Use or possible use of restrictive drugs that affect gastrointestinal motility during the study period (e.g., anticholinergics, opiates, antispasmodic drugs, stimulants, and tricyclic antidepressants); 7. During screening, blood routine, urine routine, stool routine, liver function, renal function, blood electrolyte and blood thyroid stimulating hormone showed clinically significant abnormalities (e.g., platelet 3 ULN, total bilirubin > 1.5 ULN); 8. Positive faecal occult blood test at screening stage; 9. Positive blood pregnancy test during screening for women of childbearing age; 10. Women who are pregnant or breastfeeding; 11. Participated in other interventional clinical trials in recent three months; 12. Other conditions not suitable for inclusion evaluated by the researcher.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Consistent rate of positive detection;Consistent rate of negative detection;Consistent rate of total detection; | — |
Countries
China
Contacts
Public ContactXiaohua Hou
Huazhong University of Science and Technology Shenzhen Union Hospital
Outcome results
None listed