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临床试验/ACTRN12609000558224
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

发起方
niversity of Western Sydney

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