A Synergy, Safety and Efficacy Study of ‘M Sip LaxTM’ Straw in Healthy Human Subjects Affected By Functional Constipation
试验速览
- 阶段
- 不适用
- 状态
- 已完成
- 入组人数
- 16
- 试验地点
- 1
- 主要终点
- To assess the effect of test treatment A or Treatment B or Treatment C in terms of improvement in bowel movement symptoms
研究概览
简要总结
This is a double-blind, three-arm, single-center, synergy, safety and efficacy clinical study of ‘M Sip Lax’ straw in Healthy Human Subjects affected by functional constipation.
A sufficient number (maximum of 16) of male and female adults/children subjects will be recruited to ensure a total 15 subjects complete the study. Qualifying siblings and family members within the same household are permitted on the study. Functional constipation will be diagnosed according to the Rome III criteria as having at least two of
these symptoms: < 3 defecations per week; history of excessive stool retention and painful or hard bowel movements; fecal incontinence >2 times/week; withholding of stool; the presence of a large fecal mass in the rectum; history of large-diameter stools. Children with suspected or proved organic causes of constipation, such as Hirschsprung’s disease,
hypothyroidism, or structural anomalies of the anal canal, sensitivity to study medication, those with any type of infection or fever of with type I diabetes, will be excluded from the study. Before entering the facility, at security check-point, the subject and/or the subject’s with legal parent/legal guardian will be asked for a pre-entry inquiry check for COVID-19 exposure and symptoms. The potential subjects will be screened as per the inclusion and exclusion criteria only after obtaining written informed consent from the subjects and the subject’s legal parent/legal
guardian. The adult subject and child’s legal parent/legal guardian will be instructed to visit the facility with their child as per the below visits:
-> Visit 01 (Day 00): Screening Visit and Enrolment
-> Visit 02 (Day 3+1): After Three-Day Treatment
-> Visit 03 (Day 6+1): After discontinuation of Treatment [Can be Telephonic Follow-Up]
The subjects and parents of the enrolled children will be instructed to insert one test treatment (A/B/C) per randomization code in approximately 100 mL of water and make the child/subject suck
the contents through the straw completely each night for three consecutive nights. The clinician will ensure that the adult subjects and legal parents/guardians understood the methodology for
taking sennoside with probiotic straw. Assessment of efficacy parameters will be done at all three visits during the study: Visit 1 (Day 0), Visit 2 (Day 3+1), and Visit 3 (Day 6 or 7) to evaluate patients at screening and enrollment, after three days of treatment, and at the sixth or seventh day of treatment discontinuation to assess the long-term effect of the drug, respectively.
研究设计
- 研究类型
- Interventional
- 分配方式
- Computer generated randomization
- 盲法
- Participant, Investigator and Outcome Assessor Blinded
入排标准
- 年龄范围
- 5.00 Year(s) 至 65.00 Year(s)（—）
- 性别
- All
入选标准
- •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) Subject’s and child’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
结局指标
主要结局
To assess the effect of test treatment A or Treatment B or Treatment C in terms of improvement in bowel movement symptoms
时间窗: From baseline on Day 0 before dosing Vs. Day 3 after three doses, on Day 6 after discontinuation of the treatment using Rome III criteria assessed by the Investigator
次要结局
- To assess the effect of test treatment A or Treatment B or Treatment C in terms of change in stool consistency(From baseline on Day 0 before dosing Vs. Day 3 after three-dose, on Day 6 after discontinuation of the treatment using Bristol stool grading assessed by the Investigator)
- To assess the effect of test treatment A or Treatment B or Treatment C in terms of improvement in constipation and associated symptoms such as abdominal pain, bloating, cramps, nausea etc.(From baseline on Day 0 before dosing Vs. Day 3 after three-dose, on Day 6 after discontinuation of the treatment using Visual Analogue Scale (VAS))
- To assess adult subject’s/child’s experienced on overall clinical condition by Quality of Life((QoL) subjective self-assessment quetionniaires for adults & parental/guardian questionnaires)