None listed
Conditions
Interventions
Intervention1: M Sip Lax straw: Containing both Bacillus coagulans (1 Billion CFU) and Senna leaf extract (7.5mg), 1 straw for child and 2 straw for adult a day preferably at night during bedtime for
Sponsors
Inzpera Healthsciences Limited
Eligibility
Inclusion criteria
Inclusion criteria: 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.
Exclusion criteria
Exclusion criteria:
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| To assess the effect of test treatment A or Treatment B or Treatment C in terms of improvement in bowel movement symptomsTimepoint: 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 | — |
Secondary
| Measure | Time frame |
|---|---|
| To assess adult subjectââ?¬â?¢s/childââ?¬â?¢s experienced on overall clinical condition by Quality of Life (QoL) subjective self-assessment quetionniaires for adults & parental/guardian questionnaires in terms of product perceptionTimepoint: on Day 3 after three dose of test product and on Day 6 after discontinuation of test product.;To assess the effect of test treatment A or Treatment B or Treatment C in terms of change in stool consistencyTimepoint: 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.Timepoint: 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) | — |
Countries
India
Contacts
Public ContactMaheshvari Patel
NovoBliss Research Private Limited
Outcome results
None listed