KCT0001621招募中未知
Clinical interaction study on concurrent use of Samryungbaekchulsan and Otilonium Bromide for irritable bowel syndrome : safety and effectiveness
Catholic Kwandong University International St.Mary's Hospital0 个研究点目标入组 80 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 未知
- 状态
- 招募中
- 发起方
- 入组人数
- 80
研究概览
简要总结
pre-results; submitting an article for the study protocol in-progress
研究设计
- 研究类型
- Interventional Study
入排标准
- 年龄范围
- 18(Year) 至 75(Year)（—）
- 性别
- All
入选标准
- •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
排除标准
- •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
研究者
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