ACTRN12609000558224已完成2 期
A double blind randomised placebo controlled clinical trial testing the effectiveness of a Chinese herbal medicine extract formulation for constipation-predominant Irritable Bowel Syndrome.
niversity of Western Sydney0 个研究点目标入组 160 人开始时间: 2009年7月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 160
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomised controlled trial
- 主要目的
- Treatment
- 盲法
- Blinded (masking used)
入排标准
- 年龄范围
- 18 Years 至 65 Years(—)
- 性别
- All
入选标准
- •1. Have a normal colonic evaluation test within the previous 5 years (colonoscopy or barium enema, or other colonic imaging).
- •2. Normal blood test results (full blood count, liver function test, urea & creatinine) performed within the last 3 months.
- •3. Confirmed C-IBS diagnosis by a Gastroenterologist or General Practitioner (GP).
排除标准
- •1. Pregnancy or breast-feeding.
- •2. Significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, or haematological disorders.
- •3. Diabetes mellitus requiring insulin therapy.
- •4. Epilepsy.
- •5. Inflammatory bowel disease.
- •6. Gastrointestinal tract neoplasm.
- •7. Celiac disease (by Tissue Transglutaminase (TTG) performed in the previous five years).
- •8. Current psychiatric illness or dementia (excluding clinically diagnosed depression or anxiety where the patient has been stable on medication for at least three months).
- •9. Current alcoholism or drug abuse.
- •10. Previous bowel surgery (excluding appendectomy, cholecystectomy, fundoplication).
- •11. Any serious medical or psychological disorder likely to preclude completion of the trial.
- •12. The use of Quinine, Digoxin, Thiazides, Potassium Sparing Diuretics, Ephedrine Hydrochloride, Iron-containing agents and Pancreatin drugs.
- •13. Severe Idiopathic constipation.
研究者
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