SLCTR/2013/032尚未招募3 期
A Phase IIIb/lV, Multi-centre, Double-blind, Randomised, Placebo-controlled Parallel Group Study to compare the efficacy and safety of Thriphala® with placebo in patients with constipation associated with Irritable Bowel Syndrome (IBS-C)
ink Natural Products (PVT) Ltd0 个研究点目标入组 200 人开始时间: 待定最近更新:
适应症
试验速览
- 阶段
- 3 期
- 状态
- 尚未招募
- 发起方
- 入组人数
- 200
研究概览
简要总结
暂无简介。
研究设计
- 研究类型
- Interventional
入排标准
入选标准
- •1.Patients with diagnosed IBS-C using Rome III criteria for the last 3 months, with symptom onset at least 6 months prior to diagnosis
- •2.Male and females aged 18 to 80 years
- •3.Females of child-bearing potential who consent to employ an adequate method of contraception and undergo a pregnancy test at Randomisation Visit
- •4.Willingness and competency to complete the entire study and comply with study instructions.
- •5.Patients > 50 years old have to have undergone a colonoscopy or computerised tomography (CT) after the onset of their IBS-C symptoms or within the last 5 years.
- •6.Less than 3 spontaneous bowel movements during the last 7 days of the run-in period
排除标准
- •1.History or evidence of organic disease in the large bowel, intestinal perforation or obstruction due to structural or functional disorder of the gut wall, ileus, severe inflammatory conditions of the intestinal tract such as Crohn's disease, complicated diverticulitis, ulcerative colitis, toxic megacolon and occlusive or subocclusive syndrome.
- •2.Abdominal pain of unknown cause, not related to IBS.
- •3.Previous major abdominal surgery.
- •4.IBS subtypes other than IBS-C (symptoms of IBS-diarrhoea (IBS-D) or IBS-mixed (IBS-M)
- •5.Known hypersensitivity to any of the active substances.
- •6. Laxative, drug or alcohol abuse (recent history or within previous 12 months)
- •7.Pregnant or lactating females.
- •8. Severe or acute disease within 2 weeks prior to the start of the study.
- •9.Type I or II diabetes
- •10.Use of other investigational drug s, prescribed or OTC medications affecting gastrointestinal function (anticholinergics, prokinetics, drugs affecting motility, anthraquinones. opioids,ondansetron or other 5-HT3 antagonists).
- •11.Incomplete Patient Diary Card during the run-in period.
- •12.Occurrence of diarrhoea during the run-in period.
- •13.Patients with abnormal laboratory tests, proctoscopy /abdominal ultrasound, colonoscopy, sigmoidoscopy or CT requiring further investigation.
- •14.Any condition, which, in the Investigator's opinion may put the patient at significant risk, may confound the study results, or may interfere significantly with the results of the study.
研究者
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