Effect of Flixweed and Fig on Irritable Bowel Syndrome With Predominant Constipation: a Single Blind Randomized Clinical Trial.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 150
- 试验地点
- 2
- 主要终点
- irritable bowel syndrome constipation predominant symptom
研究概览
简要总结
This study evaluates effect of Ficus carica and Descurainia Sophia on irritable bowel syndrome predominant constipation. one-third of patients will receive Ficus carica, another one-third will receive Descurainia Sophia and remained patients only will follow their regular diet for 4 months.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Single (Investigator)
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •patients with irritable bowel syndrome predominant constipation
排除标准
- •Subjects with significant cardiovascular, renal, hepatic, pulmonary, endocrine, metabolic, hematologic disorders,
- •structural abnormalities of the gastrointestinal tract or
- •diseases ⁄conditions that affected bowel transition,
- •any prokinetic or laxative drug used during the past month,
- •any medication that may affect gastrointestinal motility,
- •other therapeutic dietary advice for IBS,
- •used Fig or Flixweed during the last month,
- •diarrhea,
- •pregnancy or
- •breast-feeding
结局指标
主要结局
irritable bowel syndrome constipation predominant symptom
时间窗: 4 months
IBS severity score system questionnaires will use for evaluation of IBS-C symptoms at the pre and post-intervention. This tool is validated for use in IBS patients that assess 5 clinically relevant items during past 10-days and including severity of abdominal pain, frequency of abdominal pain, severity of abdominal distention, dissatisfaction with bowel movement and interference of IBS with life in general. Each items was scored with a 100 mm visual analogue scale (VAS).
次要结局
- quality of life in IBS-C patients(4 months)
- frequency of defecation and hard stool(4 months)
研究者
Makan Pourmasoumi
MSc Student, Food Security Research Center, Department of Community nutrition, School of Nutrition & Food Sciences, Isfahan University of Medical Sciences, Isfahan, Iran
Isfahan University of Medical Sciences