Reflexology for Patients Suffering From Chronic Constipation- a Phase II B, Single Armed, Open Label Study.
试验速览
- 阶段
- 2 期
- 入组人数
- 40
- 试验地点
- 1
- 主要终点
- Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
研究概览
简要总结
The purpose of this study is to examine if the use of reflexology can alleviate chronic constipation. The trial will last 26 week per patient, 2 week of screening period, 12 weeks of treatment and 12 weeks of follow up. Included in the study will be 40 men and women, 18 years of age or older, which are able to comply with the study guidelines; Fewer than three spontaneous bowel movement per week; and one or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months: (1) straining, lumpy or (2) hard stools, and (3) a sensation of incomplete evacuation. Exclusion criteria are: Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials; Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period; Rome III criteria for the irritable bowel syndrome; History of pelvic-floor dysfunction; Neurological pathologies; Psychiatric conditions; Chronic use of medication with a gastro intestinal-activity.
研究设计
- 研究类型
- Interventional
- 分配方式
- Na
- 干预模型
- Single Group
- 主要目的
- Treatment
- 盲法
- None
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 是
入选标准
- •Age of 18-55 years
- •Fewer than three SBMs per week (occurring without the use of a laxative, enema, or suppository within the preceding 24 hours)
- •One or more of the following symptoms/signs during more than 25% of bowel movements for at least 12 weeks within the preceding 12 months:(1)straining, lumpy or (2) hard stools, and (3)a sensation of incomplete evacuation Six or fewer SBMs/week and fewer than three complete CSBMs/week during the 14-day baseline period.
- •Ability to comply with the study guidelines
排除标准
- •Loose or watery stool in the absence of laxative use for more than 25% of bowel movements during the 12 weeks preceding the trials.
- •Mushy stool defined as a score of 6 on the Bristol Stool Form Scale for any SBM during the baseline period.
- •Rome III criteria for the irritable bowel syndrome.
- •History of pelvic-floor dysfunction.
- •Neurological pathologies
- •Psychiatric conditions
- •Chronic use of medication with a GI-activity.
结局指标
主要结局
Change in complete spontaneous bowel movements (CSBM)/week from baseline to 24 weeks
时间窗: 24 weeks
Will be assessed daily during the 24 weeks of the study
Increase of at least one CSBM per week from baseline for 9 or more weeks during the 24-week treatment period
时间窗: 24 weeks
Will be assessed weekly during the 24 weeks of the study
次要结局
- Stool frequency/Week (CSBMs and spontaneous bowel movements (SBMs)(24 weeks)
- Stool consistency/week using the 7- point Bristol Stool Form Scale, during the 24 weeks of the study period(24 weeks)
- Severity of straining using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount).(24 weeks)
- Abdominal discomfort, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)(24 weeks)
- Severity of bloating, using a 5-point ordinal scale (1 indicates not at all; 5 an extreme amount)(24 weeks)
- Constipation severity (using a 5-point ordinal scale, with higher scores indicating greater severity)(24 weeks)
- Constipation relief (based on a 7-point balanced scale, with 1 indicating complete relief, 4 indicating no change, and 7 indicating very severe constipation)(24 weeks)
- Satisfaction with the trial results, using a 5-point ordinal scale(24 weeks)
- Health related quality of life (using the validated Patient Assessment of Constipation Quality of Life instrument (PAC-QOL)(24 weeks)
- Treatment side effects(24 weeks)