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
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