A Prospective, Randomized, Double-Blind, Parallel, Placebo-Controlled Study to Evaluate the Efficacy of Gingever in Subjects with Occasional Constipation.
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Mean change from baseline in abdominal, rectal and stool related symptoms and change in fecal microbiota composition
研究概览
简要总结
This is a randomized, double-blind, parallel, placebo-controlled, clinical interventional study. Adult healthy males and/or females aged between 18 and 65 years who report with less than 3 bowel movements per week for at least 2 weeks. and meet all inclusion and no exclusion criteria will be enrolled in the study after signing a written informed consent. If a subject is eligible for study participation, at Randomization Visit (Visit 2), subjects will be randomly (Double-blind) assigned in 1:1 ratio to one of the two (2) treatment groups i.e. Test Product or Placebo. Clinical assessments and Quality of life will be assessed by questionnaire based assessments. stool samples and blood samples will be collected for the assessment of efficacy parameters. A Subject Diary will be provided to the subjects to record the study IP administration, frequency of bowel movements, side effects and concomitant medication details including rescue medications, any sick leaves during the study duration. All subjects will be instructed to complete the Subject Diary after each study IP administration. Any additional and missed administrations should also be noted in the Subject Diary. Subject Diary will be used to evaluate study IP administration compliance. study is planned to be conducted in 5 visits over a period of 56 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 65.00 Year(s)（—）
- 性别
- All
入选标准
- •BMI of 18.5 kg/m2 to 29.9 kg/m2
- •subjects who have less than 3 bowel movements per week for at least 2 weeks
- •Subjects who agree to maintain their usual level of activity throughout the trial period
- •Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
- •Subjects who agree to stay weight stable during the study period.
- •Female subjects of child bearing potential practicing an acceptable method of birth control
- •Subjects willing to provide written consent.
- •9.Subjects shall be willing and able to understand and comply with the requirements of the study, consume the study IP as instructed, return for the required treatment period visits, comply with therapy prohibitions, and be able to complete the study.
排除标准
- •1.Having hypersensitivity or history of allergy to the study product.
- •2.Suffering from a metabolic disorder
- •Subjects diagnosed with functional constipation as per Rome III criteria 4.Major gastrointestinal complication 5.Subjects suffering from lactose intolerance 6.Prior abdominal surgery 7.Current pharmacological treatment related to constipation 8.Laxative/suppository use
- •Daily consumption of probiotics, prebiotics, symbiotic, fibres, fermented milk, and/or yogurt containing probiotics within 1 month prior to screening.
- •10.Use of any drug or dietary supplement during at least 7 consecutive days known to cause constipation 11.Clinically significant underlying systemic illness that may preclude the participants ability to complete the trial or that may confound the study outcomes 12.Systemic steroid use within 1 month before screening.
- •13.Eating disorder
- •Having a lifestyle deemed incompatible with the study according to the investigator 15.Self-declare history of alcohol abuse 16.Subjects who are pregnant, nursing, or planning a pregnancy within the study participation period.
- •17.Subjects with positive Urine Pregnancy Test at Screening/Randomization Visit.
- •18.Other causes of secondary constipation 19.Subjects who have been treated with any investigational drug or investigational device within a period of 3 months prior to study entry.
- •20.Any additional condition(s) that in the Investigators opinion would warrant exclusion from the study or prevent the subject from completing the study.
结局指标
主要结局
Mean change from baseline in abdominal, rectal and stool related symptoms and change in fecal microbiota composition
时间窗: Day 0, Day 3, Day 14, Day 28, Day 56
次要结局
- Mean change from baseline in stool consistency(Day 0, Day 3, Day 14, Day 28, Day 56)
- Mean change from baseline in stool frequency as assessed by number of bowel movements(Day 0, Day 3, Day 14, Day 28, Day 56)
- Mean change from baseline in gut immunity markers(Day 0, Day 56)
- Mean change from baseline in inflammatory markers(Day 0, Day 56)
- Mean change from baseline in fecal Short Chain Fatty Acids(Day 0, Day 56)