Eligibility Module
The Eligibility Module contains detailed information about who can participate in the clinical trial. This includes eligibility criteria, age restrictions, gender requirements, healthy volunteer status, and study population descriptions, helping researchers understand who is eligible to participate in the study.
Eligibility Module path is as follows:
Study -> Protocol Section -> Eligibility Module
Eligibility Module
Ignite Creation Date:
2025-12-24 @ 5:24 PM
Ignite Modification Date:
2025-12-24 @ 5:24 PM
NCT ID:
NCT01695850
Eligibility Criteria:
Inclusion Criteria:
* either gender aged 18 to 65 years
* have FC diagnosed as Rome III criterial
* have diagnosis of Excessive Constipation according to the TCM theory
* complete spontaneous bowel movement (CSBM) ≦2times/w
* severity of constipation≧3pts (7 pts scale from 0 to 6pts) and the overall scoring of constipation-related symptoms≧6pts (6items in 7pts scale) for self symptom assessment in the run-in period
* normal colonic evaluation (colonoscopy or barium enema) within 12 months
* normal liver and renal function in blood test within 3 months
Exclusion Criteria:
* drug-induced constipation
* secondary causes of constipation (i.e. medical history of diabetes mellitus and thyroid disease)
* abdominal surgery (i.e. Caesarean operation)
* severe diseases (i.e. cancer and acute present asthma)
* allergy to CHM (i.e. G6PD deficiency), senna and tartrazine
* pregnancy or breast-feeding
* psychiatric or addictive disorders
Healthy Volunteers:
False
Sex:
ALL
Minimum Age:
18 Years
Maximum Age:
65 Years
Study:
NCT01695850
Study Brief:
Protocol Section:
NCT01695850