None listed
Conditions
Interventions
Drug : I : over 20
Samryungbaekchulsan +Otilonium Bromide Placebo
II:over 20
Samryungbaekchulsan Placebo +Otilonium Bromide
III :over 20
Samryungbaekchulsan +Otilonium Bromide
IV:over 20
Samryungba
Sponsors
Catholic Kwandong University International St.Mary's Hospital
Eligibility
Sex/Gender
All
Inclusion criteria
Inclusion criteria: 1. patients aged 18-75 years 2. patients with consistent abdominal pain and discomfort should meet the Rome ? criteria of Irritable bowel syndrome(recurrent abdominal pain or discomfort at least 3days in a month in the last 3 months associated with two or more of the following. 1. Improvement with defecation, 2. onset associated with a change in frequency of stool, 3. onset associated with a change in form of stool) 3. Among Irritable bowel syndrome subtypes, participants must also be included in the Irritable bowel syndrome Diarrhea type, defined as loose (mushy) or watery stools (Bristol Stool Chart Scale 6-7) at least 2days 4. Women with childbearing potential will be required to have a negative pregnancy urine test in 7 days, and should agree to keep contraception for this examination period 5. Participants can understand and complete the questionnaire 6. Participants agree to clinical trial plan and follow up plan, voluntarily sign consent form approved by IRB
Exclusion criteria
Exclusion criteria: 1. Chronic hepatitis B, C or liver cirrosis 2. Kidney function abnormalities (serum creatinine > 2 times of normal eange), chronic renal failure patients 3. Abnormalities in liver function test (Alanine Transaminase/Aspartate Transaminase > 3 times of normal range) 4. Uncontrolled diabetes(HbA1c>8%) or hypertension( Systolic Blood Pressure>160mmHg or Diastolic Blood Pressure>100mmHg) by dietary or drug treatment (HbA1c>8%). or hypertension (systolic or diastolic blood pressure of = 140/90 mmHg), severe systemic organ disease such as heart disease(congestive heart failure, ischemic heart failure), pulmonary disease, nerve disorder. 5. History of abnormal opinion on colonoscopy or colonography in recent 5 years (except, removed colon polyp) 6. History of surgery(gastrectomy, enterectomy, hysterectomy) which affect the daily work out 7. Those with a history of the following diseases within the previous 6 months were also excluded; peptic ulcer disease, GI bleeding, gastroesophageal reflux disease, intestinal stenosis or obstruction, infectious diarrhea, and pancreatic insufficiency. 8. psychotic disorder, alcohol abuser, drug abuser 9. Patinets with severe systemic disease such as malignancy of organs other than digestive (except for cases with no recurrence for over 5 years since treatment), autoimmune disorder, stoke 10. pregnant and lactating women 11. Take medicines such as antiulcerants, gastric antiacids, aperients, antispasmodics, gastrokinetics, prostagladin drugs, antidiarrheal drugs, probiotics, intestinal drugs, serotonin drugs, antibiotics, chloride ion chnnel drugs, cholaneresis drugs, antiinflammatory drugs, antidepressants, antianxiety agents, adrenocorticotrophics in recent 2 weeks. 12. Man who taking some medicines which has drug interaction with SBS or Otilonium bromide . 13. Lactose intolerance patient that uncontrolled by food refulation 14. Glucoma patient 15. The man who have participated in another clinical research and taken other drugs in 30days befor screening test 16. Patients were excluded if they were intolerable of or sensitive to study drug
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| evaluation of severity (abdorminal pain, abdorminal distension, satisfaction of defecation, quality of life, frequency of abdorminal pain), condition of defecation (Bristol Stool Scale), frequency of ;physical test, vital signs, laboratory test, subjective symptoms, objective symptoms;symotome relaxation rate by subject global assessment of relief | — |
Secondary
| Measure | Time frame |
|---|---|
| cortisol, corticotropin-releasing hormone (CRH), serotonin, cytokines group I (10ea), cytokines group II (14ea), growth factors (3ea) | — |
Countries
Korea, Republic of
Contacts
Public ContactTae-Yong Park
Catholic Kwandong University
Outcome results
None listed