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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)

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)

Status
Active, not recruiting
Phases
Unknown
Study type
Interventional
Source
CRIS
Registry ID
KCT0008045
Enrollment
30
Registered
2022-12-29
Start date
2022-04-28
Completion date
Unknown
Last updated
2023-01-10

For informational purposes only — not medical advice. Sourced from public registries and may not reflect the latest updates. Terms

Conditions

None listed

Interventions

Dietary Supplement : Take a test food (500mL/day as a bamboo (bamboo shoots) sandstone extract compound) or a control food (500mL/bottle of purified water mixed with mugwort-flavored food additives) o

Sponsors

Hongcheon Institute of Medicinal Herb
Lead Sponsor

Eligibility

Sex/Gender
All

Inclusion criteria

Inclusion criteria: 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

Exclusion criteria

Exclusion criteria: 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

Design outcomes

Primary

MeasureTime frame
Dissolution rate through MCS

Secondary

MeasureTime frame
Fecal Calprotectin;IBDQ(Inflammatory Bowel Disease Questionnaire)

Countries

Korea, Republic of

Contacts

Public ContactHyun Gun Kim

Soon Chun Hyang University

medgun@naver.com+82-2-709-9202

Outcome results

None listed

Source: CRIS (via WHO ICTRP) · Data processed: Feb 4, 2026