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.