A 12 week, Randomized, Double-Blind, Placebo-Controlled, Exploratory Clinical Trial for the Evaluation of the Efficacy and Safety of BA on Inflammatory Bowel Disease(Ulcerative Colitis)
- Conditions
- Not Applicable
- Registration Number
- KCT0008045
- Lead Sponsor
- Hongcheon Institute of Medicinal Herb
- Brief Summary
Not available
- Detailed Description
Not available
Recruitment & Eligibility
- Status
- Completed
- Sex
- All
- Target Recruitment
- 30
1) adults over 19 and under 70
2) Mayo Clinic Score (MCS) with a total score of 3 or more and 10 or less
3) A person who is able to maintain IBD treatment drugs (such as 5-ASA) in accordance with IBD treatment standards and prescriptions by the person in charge of treatment
4) A person who agrees to participate in the human body application test and signs a written consent form prior to the commencement of the human body application test
1) A person who is currently being treated for infectious diseases including severe cardiovascular system, immune system, respiratory system, hepatometer, kidney and urology system, nervous system, musculoskeletal system, mental health, and skin
2) A person with a history of forearm resection
3) Those who are likely to undergo bowel resection within 3 months
4) A person who has a history of solid cancer and blood cancer within five years;
5) People with autoimmune diseases including Crohn's disease
6) A person who has or has complications such as stenosis or perforation in the gastrointestinal tract
7) A person who has administered immunomodulators or biological agents such as systemic steroids, TNF-a Inhibitors, Azathioprine, and MTX within 3 months of visit 1
8) Those who consume excess alcohol within one year (men > 210 g/week, women > 140 g/week) based on visit 1
9) BMI = 30 kg/m2 factor
10) Patients with uncontrolled hypertension (measured after stabilizing for 10 minutes with systolic blood pressure of 160 mmHg or higher or diastolic blood pressure of 100 mmHg or higher)
11) Uncontrolled diabetics (above 180 mg/dL of fasting blood sugar)
12) A person whose AST (GOT) or ALT (GPT) is three times or more than the upper limit of the normal limit of the implementing institution;
13) A person whose creatinine is twice or more than the upper limit of the implementation agency's normal limit
14) A person who is pregnant or who has a plan to become pregnant during the nursing mother or during this human body application test
15) A person who has participated in other interventional clinical trials (including human application tests) within 3 months of visit 1 or plans to participate in other interventional clinical trials (including human application tests) after the start of this human application test
16) A person who is sensitive to or allergic to food ingredients for this human body application test
17) A person who judges that the tester is inappropriate for other reasons
Study & Design
- Study Type
- Interventional Study
- Study Design
- Not specified
- Primary Outcome Measures
Name Time Method Dissolution rate through MCS
- Secondary Outcome Measures
Name Time Method Fecal Calprotectin;IBDQ(Inflammatory Bowel Disease Questionnaire)