A 4 week, randomized, double-blind human trial to evaluate the efficacy and safety of Fermented hot pepper(Gochujang powder) on intestinal microflora and improved bowel movements

Not Applicable

Recruiting

Conditions: Diseases of the digestive system

Registration Number: KCT0007670

Lead Sponsor: Jeonbuk National University Hospital

Brief Summary: Not available

Detailed Description: Not available

Recruitment & Eligibility

Status: Recruiting

Sex: All

Target Recruitment: 45

Inclusion Criteria

(1) Males and females aged over 19 and below 70 at the screening examination
(2) Participants who meet the functional constipation diagnosis criteria of Roman Diagnostic Standard IV
• The following symptoms begin six months ago and the symptoms are more than two in the past three months
? over 25% of the times of bowel movements the excessive force is given in bowel movements
? More than 25% of the number of bowel movements in the case of hard and lumpy stools
? residual feeling after bowel movements is over 25% of the whole bowel movements times
? the anal closure feeling in bowel movements is 25% or more of the times of bowel movements
? More than 25% of the number of bowel movements when the manual manipulation to help bowel movements is required
? bowel movements of less than three times a week
(3) Participants who have fully understand the information provided about the study voluntarily decided to participate and agree to comply with precautions

Exclusion Criteria

1) Patients who have clinically significant acute or chronic cardiovascular relationships, endocrine systems, immune systems, respiratory systems, hepatic biliary systems, kidneys and urinary systems, neuropsychiatric systems, musculoskeletal systems, inflammatory and blood and tumor, gastrointestinal diseases, etc.
2) Patients with a history of significant hypersensitivity reactions to red pepper and red pepper paste ingredients
3) Patients who have received anti-psychotic medication within three months before screening examinations
4) Patients who have or are suspected of alcoholism or substance abuse
5) Patients who have participated in other clinical trials within 3 months prior to the screening examination
6) Women who are pregnant or breastfeeding
7) Patients who have not accepted the implement of appropriate contraceptive method among women who are fertile
8) Patients who are judged ineligible to participate in the trial by the principal investigator for other reasons, including laboratory test outcomes