Chronic constipation
Conditions
Interventions
Placebo group:placebo
Aurantii Fructus Immaturus flavonoid tablets low dose group:Aurantii Fructus Immaturus flavonoid tablets 3 tablets (tid.)
Aurantii Fructus Immaturus flavonoid tablets high dose group:Aurantii Fructus Immaturus flavonoid tablets 6 tablets (tid.)
Sponsors
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Eligibility
Sex/Gender
Male
Age
18 Years to 200 Years
Inclusion criteria
Inclusion criteria: 1: Voluntary participation and signed informed consent 2: Male or female subjects =18 years of age 3: Female subjects who are not pregnant or breastfeeding at the start of the study and male and female subjects who are using contraception during the study 4: Normal colonoscopy at a tertiary care hospital within 3 years prior to screening or those with mild abnormalities in the judgement of the investigator that do not explain the symptoms of constipation. Subjects who have intestinal polyps with a polyp status that does not require immediate treatment (criteria for needing treatment: polyps directly >0.5cm or number >3 or visible villous tissue etc.) and intestinal polyp removers who have had no bleeding for at least 1 month are eligible to participate in the study 5: Meet the Rome IV diagnostic criteria for functional constipation: symptoms for at least 6 months prior to diagnosis and the following criteria for the last 3 months (as required by the revised Rome IV diagnostic criteria for functional constipation). The subject reports few loose stools when laxatives are not used which does not meet the Rome IV diagnostic criteria for Irritable Bowel Syndrome (IBS); does not use manoeuvre-assisted defecation (e.g. finger-assisted defecation pelvic support for defecation); and reports spontaneous defecation less than 3 times per week. Subjects report at least two of the following: 1/4 (25%) or more straining to pass stools 1/4 (25%) or more dry bulbous or hard stools (Bristol Stool Profile Scale type 1-2) 1/4 (25%) or more incomplete stools 1/4 (25%) or more anorectal obstruction/blockages 6: Decreased intestinal transport function as determined by intestinal transport function testing 7: Subject completes a screening period diary card for at least 10 days as assessed within 14 days prior to treatment 8: Subject agrees not to make any new major lifestyle changes between the time of signing informed consent and the final visit
Exclusion criteria
Exclusion criteria: 1: Known allergy or contraindication to the study drug or remedial drug 2: Presence of currently unexplained and clinically significant alarm symptoms 3: Known constipation due to secondary factors (multiple sclerosis Parkinson's disease spinal cord injury etc.) 4: Known organic diseases of the intestine (e.g. inflammatory bowel disease intestinal obstruction etc.) 5: Colonic transport test showing an outlet obstruction type 6: Other chronic conditions in which the subject has abdominal pain abdominal discomfort that may interfere with efficacy assessment (e.g. chronic pancreatitis endometriosis etc.) 7: Active peptic ulcer 8: Previous gastrointestinal surgery 9: Presence of a history of malignancy 10: Alcohol abuse or severe psychiatric disorders 11: Known clinically significant liver or renal impairment active viral hepatitis diabetic peripheral neuropathy and other organic diseases 12: Subject has used a remedial medication (bisacodyl) or any other laxative suppository or enema within 72 hours prior to the first dose of medication 13: Subject reported use of the remedial drug bisacodyl for =3 days during any of the two weeks of the 2-week pre-treatment assessment period 14: Subjects deemed by the investigator to be unsuitable to participate in the study
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Colonic transit time; | — |
Secondary
| Measure | Time frame |
|---|---|
| First SBM/CSBM;Response rate for constipation (CSBM+1);Quality of life;frequency of defecation (CSBM SBM);Use of remedial medicines;Treatment satisfaction;Stool consistency; | — |
Countries
China
Contacts
Public ContactXiaohua Hou
Union Hospital Tongji Medical College Huazhong University of Science and Technology
Outcome results
None listed