None listed
Conditions
Interventions
Dietary Supplement : •TMG22-7(high content of Effective Microorganisms, gochujang powder): 2 times a day, 3 packs once, after breakfast/dinner(25.3 g/day, 19 g/day for gochujang powder)
•TCG22-25(low
Sponsors
Jeonbuk National University Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
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
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
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| change of intestinal microbiome;colon transit time | — |
Secondary
| Measure | Time frame |
|---|---|
| bowel related questionnaire;PGA(Patient global assessment);intestinal environment improvement related index | — |
Countries
Korea, Republic of
Contacts
Public Contacthui-yeon jang
Jeonbuk National University Hospital
Outcome results
None listed