NCT01185431已完成不适用
Randomized, Double-Blind, Placebo-Controlled, Parallel Trial in Female Volunteers With Functional Constipation, to Evaluate the Improvement in Bowl Movement of Ficus Carica
适应症
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 2
- 主要终点
- Colonic transit time
研究概览
简要总结
This trial is being conducted to look for following changes when fig paste is taken by female subjects with functional constipation:
To evaluate the improvement of the bowel
To assess the quality of life and impact on female reproductive function
To evaluate the influence on glucose, cholesterol, HDL-cholesterol, LDL-cholesterol
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
- Triple (Participant, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 19 Years 至 40 Years（Adult）
- 性别
- Female
- 接受健康志愿者
- 否
入选标准
- •Subjects who are female volunteers (unmarried), 19~40 years
- •Subject who have functional constipation by ROME IIII criteria
- •Subject who have over 36 hour colonic transit time
- •Subject must provide written informed consent to participate in the study
排除标准
- •Subject with a history or evidence of clinically significant gastrointestinal, anorectal, hepatic, renal, neurological, pulmonary, endocrine, blood tumor, psychiatric, Cardiovascular disease
- •Subjects who have a gastrointestinal (GI) disease (Crohn's disease, etc.) that would increase the influence with absorbance medication or a GI surgery excluding appendectomy and hernia surgery
- •Subject with uterine fibroids at ultrasonography
- •Subject is pregnant, planning to become pregnant, or breast-feeding
- •Subjects with childbearing potential (i.e. pre-menopausal, not surgically sterile) not willing to use a medically accepted contraceptive (oral contraception) regimen
- •Known history of moderate to severe hepatic impairment (i.e., serum ALT>1.5×ULN, AST>1.5×ULN)
- •Subjects with uncontrolled hypotension (indicated by a sitting systolic blood pressure ≤ 95 mmHg or diastolic blood pressure ≤ 60 mmHg measured) and hypertension (indicated by a sitting systolic blood pressure≥ 150 mmHg or diastolic blood pressure≥ 95 mmHg measured) at vital sign measurement
- •Subjects with significant hypersensitivity about Ficus carica
- •Subjects who received certain medications that cause the alteration of bowel movement within the past 2weeks prior to first administration
- •Subjects who participated in other clinical investigation within 2 months prior to first administration
- •Subject who drink constantly (21 units/week over)
- •Subject who have Irritable bowel syndrome by ROME IIII criteria
- •Any significant condition that, in the opinion of the investigator, could interfere with the subject's participation or compliance in the study (i.e., laboratory test and others)
结局指标
主要结局
Colonic transit time
时间窗: 116 day
Colonic transit time is measured in study visit 1 (as screening test), 3 (60day) and 5 (116day).
次要结局
- Questionnaire for evacuation(116 day)
- Questionnaire for quality of life(116 day)
- Questionnaire for woman reproductive function(116 day)
研究者
研究点 (2)
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