CTRI/2022/02/040158已完成未知
A Synergy, Safety and Efficacy Study of ââ?¬Ë?M Sip LaxTMââ?¬â?¢ Straw in Healthy Human Subjects Affected By Functional Constipation
试验速览
- 阶段
- 未知
- 状态
- 已完成
- 入组人数
- 16
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) Age: For children: 5 to 12 years (both inclusive) at the time of parental consent and For
- •Adults: 18 to 65 years (both inclusive) at the time of consent.
- •2) Sex: Healthy children (male or female) and adults (males and non-pregnant/non-lactating
- •females) affected by functional constipation.
- •3) Diagnosis of functional constipation according to the Rome III criteria as having at least
- •two of these symptoms:
- •- Less than three bowel movements per week
- •- Manual maneuvers are necessary to facilitate defecation more than 25% of the time.
- •- Hard or lumpy stools more than 25% of the time
- •- Sensation of incomplete evacuation more than 25% of the time
- •- Sensation of anorectal obstruction more than 25%of the time
- •- Straining with defecation more than 25% of the time
- •4) Females of childbearing potential have a self-reported negative urine pregnancy test at
- •the time of screening visit, agree to follow an accepted method of birth control for the
- •duration of the study such as condoms, foams, jellies, diaphragm, intrauterine device etc.
- •5) Subjects (adults and children) are generally in good general health as determined from a
- •recent medical history, except for functional constipation.
- •6) Ability of subject to sip and suck the straw.
- •7) Subjects who agree to discontinue the use of probiotic supplements including foods
- •supplemented with probiotics or fiber supplements including foods labelled
- •as supplemented with fiber.
- •8) Subjects who agree to discontinue use of over-the-counter laxative medications
- •throughout the trial.
- •9) Subjects who are willing to complete all study procedures including study-related
- •questionnaires and comply with study requirements.
- •10) Subjectââ?¬•s and childââ?¬•s legal parent/guardian must read, sign, and receive a copy of Informed
- •Consent/Parental Informed Consent prior to initiate of study procedures.
排除标准
- 未提供
研究者
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