A clinical study to determine the safety, a combined effect of probiotics and Senna combined the Test product, ââ?¬Ë?M Sip LaxTMââ?¬â?¢ Straw in Healthy Human Subjects Affected By Functional Constipatio

Not Applicable

Completed

• Registration Number: CTRI/2022/02/040158
• Lead Sponsor: Inzpera Healthsciences Limited

Brief Summary

Not available

Detailed Description

Not available

Study Timeline

• Results First Posted: 1900-01-01
• Study Completion: 2022-03-19
• Last Update Posted: 17 October 2022

Recruitment & Eligibility

• Status: Completed
• Sex: Not specified
• Target Recruitment: 16

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

Not provided

Study & Design

• Study Type: Interventional
• Study Design: Not specified