NCT00990951暂停3 期
Double-blind, Randomized, Placebo-controlled Study of Efficacy of Association of Senna Alexandrina, Cassia Fistula, Tamarindus Indica, Coriandrum Sativum, Periandra Mediterranea in Patients With Functional Intestinal Constipation
适应症
干预措施
相关药物
试验速览
- 阶段
- 3 期
- 状态
- 暂停
- 入组人数
- 80
- 试验地点
- 1
- 主要终点
- average frequency of bowel movements measured at baseline and at 2 weeks of treatment
研究概览
简要总结
The purpose of this study is to evaluate the efficacy of association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub. in patients with functional constipation.
详细描述
This is a phase III trial, placebo-controlled with a parallel-group design.
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
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 65 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients between 18-65 years with functional constipation by ROME IIII criteria
- •In the opinion of the investigator the patient will adhere to the protocol
- •Voluntary able to understand the nature and purpose of the study, including the risks and adverse effects and with intent to cooperate with the researcher and act in accordance with the requirements of the entire protocol, which was confirmed by signing the Consent Informed
排除标准
- •hypersensitivity to any component
- •pregnant or lactating
- •abdominal pain of unknown etiology
- •suspected intestinal occlusion and sub-occlusion
- •suspected abdominal inflammatory conditions (as appendicitis, peritonitis, cystitis, endometritis)
- •Crohn disease and colitis
- •Suspected intestinal constipation due abdominal surgery, neurological disorders (as aganglionoses, Parkinson disease, medullar tumor, stroke, multiple sclerosis), systemic sclerosis, multiple myeloma, scleroderma
- •Subjects with congenital mega colon, anorectal congenital malformation, inflammatory bowel disease or intestinal carcinoma
- •history of mal-absorption diseases
- •history of anemia, weight loss or anal bleeding
- •history of hypothyroidism, hyperthyroidism and insulin-dependent diabetes mellitus
- •known of positive result for human immunodeficiency virus test
- •heart, liver, lung or kidney important condition
- •drug or alcohol dependence
- •knowledge or suspicion of malignancy
- •body mass index < 18
- •body mass index > 30
- •participation on any experimental study 12 months prior this study
- •familiar history of colon carcinoma or inflammatory disease
- •Lack of adherence to the procedures of the protocol
研究组 & 干预措施
Senna alexandrina and associations
Experimental
Association of Senna alexandrina Mill (sena), Cassia fistula L., Tamarindus indica L., Coriandrum sativum L., Periandra mediterranea Taub
干预措施: Senna alexandrina and associations (Drug)
结局指标
主要结局
average frequency of bowel movements measured at baseline and at 2 weeks of treatment
时间窗: 2 weeks
次要结局
- degree of improvement of constipation according to the subjective evaluation of the volunteer, measured by the scores of the Global Assessment of the patient(2 weeks)
- Proportion of stools with pain and difficulty(2 weeks)
- number of consecutive days that patients do not evacuate(2 weeks)
研究者
研究点 (1)
Loading locations...
相似试验
已完成
4 期
Statin Therapy in Heart Failure: Potential Mechanisms of BenefitHeart Failure, CongestiveNCT00233480University of California, Los Angeles27
已完成
2 期
Phase II Study of STA-2 in Patients With Chronic Stable AnginaChronic Stable AnginaNCT01484912Sinphar Pharmaceutical Co., Ltd79
已完成
不适用
Evaluation of the Effect of a Combination of Plants to Regulate MoodMood RegulationNCT06138470Comercial Quimica Masso, S.A180
已完成
不适用
Possible Effects of the Dietary Supplement Magnesium Compared to PlaceboHealth PromotionNCT06332248Dan Hasson1,013
Unknown
2 期
Clinical Study to Evaluate the Efficacy of HUDC_VT in Patients With Bacterial VaginosisHUDC_VTHaudongchunBacterial VaginosisNCT03357666Haudongchun Co., Ltd.150