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
干预措施
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 40
- 试验地点
- 1
- 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)
研究组 & 干预措施
Ficus carica (Fig paste)
Experimental
干预措施: Ficus carica (Fig paste) (Dietary Supplement)
Control (Placebo paste)
Placebo Comparator
干预措施: Placebo (Placebo paste) (Dietary Supplement)
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 (1)
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