The exploratory study for the efficacy and the safety of Daikenchuto(TJ-100) on abdominal pain and abdominal fullness feeling in the patients with fecal incontinence.
Not Applicable
- Conditions
- Abdominal pain and abdominal fullness feeling in the patients with fecal incontinence
- Registration Number
- JPRN-UMIN000030252
- Lead Sponsor
- Medical Corporation Seiaikai, Gion Usshita Hospital
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Complete: follow-up complete
- Sex
- All
- Target Recruitment
- 50
Inclusion Criteria
Not provided
Exclusion Criteria
1)Patients who have anal sphincter injury 2)Patients who have severe mental illness 3)Patients who can not perform their daily activities 4)Suspected organic disease such as the cancer in gastrointestinal tract 5)Presence of serious complications (liver, kidney, heart, or blood disease or metabolic disease) 6)Patients who took drugs prohibited for concomitant use 2 weeks before entry. 7)History of allergic reactions to Kampo medicines 8)Pregnant or lactating women or those who are planning to conceive during the study period 9)Considered ineligible to participate by principal investigator or sub-investigator
Study & Design
- Study Type
- Interventional
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method 1) Numeric Rating Scale (NRS) of abdominal pain 2) NRS of abdominal fullness feeling
- Secondary Outcome Measures
Name Time Method