CTRI/2022/07/044075尚未招募不适用
A randomized, double blinded, placebo controlled comparative study to evaluate the effect of ASFP001/21 and SMXP001/22 on improvement in quality of life in healthy volunteers with mild to moderate functional dyspepsia symptoms.
Akay Natural Ingredients Pvt Ltd1 个研究点 分布在 1 个国家目标入组 93 人开始时间: 2022年7月18日最近更新:
试验速览
- 阶段
- 不适用
- 状态
- 尚未招募
- 发起方
- 入组人数
- 93
- 试验地点
- 1
- 主要终点
- Improvement in quality of life in mild to moderate functional dyspepsia symptoms
研究概览
简要总结
This is a double-blind, randomized (1:1:1), placebo-controlled, comparative clinical study. Subjects having mild to moderate functional dyspepsia symptoms [ meeting all inclusion and no exclusion criteria] after signing a written informed consent will be enrolled in the study. The subject will undergo laboratory assessment, cognitive function tests, biomarker assessments, and other questionnaire-based assessments at different time points .The study is planned to be conducted in 5 visits over a period of 14 days.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant and Investigator Blinded
入排标准
- 年龄范围
- 18.00 Year(s) 至 75.00 Year(s)（—）
- 性别
- All
入选标准
- •1.Fulfilling Rome IV diagnostic criteria for functional dyspepsia 2.Female subjects who are non-pregnant, non-lactating, postmenopausal, surgically sterilized, or using a medically acceptable form of birth control, as determined by the investigator
- •Must be willing and able to give informed consent and comply with the study procedures.
排除标准
- •1.History of peptic ulcer, gastro oesophageal reflux disease, gastro intestinal surgery or any other clinically significant gastro intestinal disease, gastrointestinal bleeding, mechanical obstruction, perforation, gastrointestinal cancer.
- •2.Subjects who have taken antibiotics or any other drugs in last 2 weeks with primary site of action in the gastro intestinal tract 3.History of psychiatric illness 4.History of congestive heart failure or uncontrolled hypertension 5.Subjects with abnormal haematological or biochemical parameters.
结局指标
主要结局
Improvement in quality of life in mild to moderate functional dyspepsia symptoms
时间窗: Day 0, Day 2, Day 3, Day 7 and Day 14
次要结局
- Change in Gastro Intestinal Symptoms(Day 0, Day 2, Day 3, Day 7 and Day 14)
- Change in gut microbiota(Day 0 and Day 14)
- Change in cognitive functions(Day 0 and Day 14)
研究者
研究点 (1)
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