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临床试验/DRKS00005183
DRKS00005183进行中(未招募)未知

irritable bowel syndrome – improvement to the clinical situation by the use of humic acid - WH67® - irritable bowel syndrome

WH Pharmawerk Weinböhla GmbH0 个研究点目标入组 46 人开始时间: 2013年8月2日最近更新:
适应症

试验速览

阶段
未知
状态
进行中(未招募)
发起方
入组人数
46

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
Randomized controlled study
盲法
Blinded (masking used)

入排标准

年龄范围
18 Years 至 one(—)
性别
All

入选标准

  • irritable bowel syndrome - diarrhea-predominant (RDS-D) --> according to ROM III criteria (diarrhea / pain)
  • male and female patients = 18 years
  • patients, who are willing and able to realise the study visits (e.g. no planned holidays)
  • patients, who are willing and able to complete the patient diary
  • last to weeks (screening phase) at least two times complaints (pain, discomfort) per week
  • willing to forgo medications of the forbidden medication list
  • Written informed consent

排除标准

  • irritable bowel syndrome - obstipation-predominant (RDS-O)
  • diagnosed, inflammatory bowel disease, as Morbus Crohn, Colitis ulcerosa, chronic inflammatory bowel disease
  • clinical reference to colon cancer (colonoscopy without pathological findings from the last 5 years for patient > 55 years)
  • clinical reference to an acute infection
  • history of known chronic gastritis or inflammatory bowel diseases
  • history of known coeliac
  • history of known lactose intolerance
  • patients with serious diseases in connection with vital medications
  • naturopathic measures regarding irritable bowel syndrome during the last 6 months before screening
  • current regular intake of medications influencing motility
  • addiction
  • history of known hypersensitivity compared to the substances / medical product
  • participation in other interventional trials during the last 4 weeks before screening
  • knowing pregnancy

研究者

发起方
WH Pharmawerk Weinböhla GmbH

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