Efficacy and Safety of nF1; A 8 week, Multi center, Randomized, Double-blind, Placebo-Controlled Clinical Trial
- Conditions
- Diseases of the digestive system
- Registration Number
- KCT0002867
- Lead Sponsor
- Biogenicskorea
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Recruiting
- Sex
- All
- Target Recruitment
- 111
1) All men and women aged between 20 and 75 years
2) The subject, whose symptoms of the disease manifested before at least 6 month, in the last 3 months. Also, more than two of the followings that apply to oneself.
? Straining during more than 25% of defecations
? Lumpy or hard stools in more than 25% of defecations
? Sensation of incomplete evacuation for more than 25% of defecations
? Sensation of anorectal obstruction/blockage for more than 25% of defecations
? Manual maneuvers to facilitate more than 25% of defecations (e.g., digital evacuation, support of the pelvic floor)
? Fewer than three defecations per week
1) Subjects who underwent abdominal surgery (except, appendectomy, Caesarian section, herniotomy)
2) IBS-C: irritable bowel syndrome with constipation(According to Rome IV diagnostic criteria)
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method umber of defecation and stool type
- Secondary Outcome Measures
Name Time Method Calprotectin;Adverse Event