CTRI/2016/10/007386已完成2 期
A double-blind, placebo controlled, randomized, clinical study to evaluate the efficacy and safety of test formulations
ITC LIFE SCIENCES AND TECHNOLOGY CENTER1 个研究点 分布在 1 个国家目标入组 120 人开始时间: 2016年6月8日最近更新:
适应症
试验速览
- 阶段
- 2 期
- 状态
- 已完成
- 发起方
- 入组人数
- 120
- 试验地点
- 1
- 主要终点
- Changes from baseline to visit 4 in dyspepsia in PP population.
研究概览
简要总结
This study will be conducted as, double blind, placebo controlled, randomized, clinical study assessing safety and efficacy of two herbal test formulations and a standard herbal reference in controlling Dyspepsia in subjects with age range between 18 to 65 years (inclusive of both the ages).
研究设计
- 研究类型
- Interventional
- 分配方式
- Stratified block randomization
- 盲法
- Participant, Investigator, Outcome Assessor and Date-entry Operator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •> Male or female dyspepsia subjects aged between 18 to 65 years of age at the time of screening visit.
- •> Subject clinically diagnosed with dyspepsia.
- •> Subject must be able to understand and complete questionnaires.
- •> Subject must be willing to or likely to comply with all study requirements.
- •> Subject willing to voluntarily sign the informed consent form.
- •> Subject meeting all the laboratory parameters set forth to qualify to enroll in the study.
排除标准
- •> Use of Proton pump inhibitors (PPIs), H2 receptor antagonists and prokinetics.
- •> Subjects with Acute peptic ulcer, severe GERD and/or ulcer complications.
- •> Systemic glucocorticoids or non-steroidal anti-inflammatory drugs (NSAIDs) including COX-2-inhibitors.
- •> Complications of gastroesophageal reflux disease which in the opinion of the Investigator may preclude trial participation.
- •> Severe or unstable systemic disease/ disorder.
- •> Intake of psychotropic medication, dyspepsia-inducing drugs, and anticholinergic agents.
- •> Diagnosis of any other clinically significant medical condition or serious gastrointestinal disorder which in opinion of investigator may jeopardize subject’s safety and preclude trial participation.
- •> Subjects with medical history of surgery of esophagus, stomach or duodenum.
- •> Abuse of drugs or alcohol confirmed by history.
- •> Pregnant or nursing female patients; Non-pregnant, non-lactating female patients of childbearing potential who are not using reliable method of contraception.
- •> Subjects with deteriorating health status at the time of enrollment.
- •> Autoimmune diseases, recent blood donation, immunodeficiency disease (e.g., human immunodeficiency virus [HIV] infection and hepatitis B) > Currently participating or having participated in another clinical trial during the last 3 months prior to the beginning of this study.
- •> Subjects unwilling or unable to comply with the study procedures.
- •> History of allergy to any component of the study product.
结局指标
主要结局
Changes from baseline to visit 4 in dyspepsia in PP population.
时间窗: Day: 14 & 28
次要结局
- Assessment of safety among the study population(Day: 28)
研究者
研究点 (1)
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