CTRI/2022/01/039843已完成未知
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
- 未知
- 状态
- 已完成
- 入组人数
- 30
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. BMI of 18.5 kg/m2 to 29.9 kg/m2
- •2. subjects who have less than 3 bowel movements per week for at least 2 weeks
- •3. Subjects who agree to maintain their usual level of activity throughout the trial period
- •4. Subjects who agree to maintain their usual dietary habits and level of exercise i.e. maintain their usual life-style throughout the trial period.
- •5. Subjects who agree to stay weight stable during the study period.
- •6. Female subjects of child bearing potential practicing an acceptable method of birth control
- •7. Subjects willing to provide written consent.
- •8. 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
- •3. 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
- •9. 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
- •14. 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.
研究者
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