Health Condition 1: K590- Constipation
Conditions
Interventions
None listed
Sponsors
Lupin Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Male or female subjects between the age group of 18 to 70 years (Cohort 1) and 6 to 15 years (Cohort 2) Subjects diagnosed as per the Rome IV diagnostic criteria for Functional constipation, 2016 (Cohort 1) and ROME IV Criteria for Functional Constipation (H3a) (Cohort 2) 3. Subjects who are ready to provide written informed consent and who are ready to willingly participate and follow the protocol requirements of the clinical study.
Exclusion criteria
Exclusion criteria: Subjects diagnosed with colonic inertia. 2. Subjects who have recently undergone abdominal surgery 3. Subjects with history of anorectal surgery. 4.Subjects having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.) 5. Subjects diagnosed with structural abnormalities of intestine 6. Subjects with uncontrolled DM and hypertension and Tuberculosis. 7. Known cases of HIV, tuberculosis, hypo and hyperthyroidism 8. Known cases of renal or liver dysfunction. 9. Subjects diagnosed with neurological problems 10. Subjects on chronic medication ( >60 days) and/or who are on medications known to cause constipation. 11. Pregnant or lactating females (Cohort 1) 12. Subjects allergic or atopic to any of the ingredients of the study medications 13. Other conditions, which in the opinion of the investigators makes the patient unsuitable for enrolment or could interfere in adherence to of the study protocol.
Design outcomes
Secondary
| Measure | Time frame |
|---|---|
| Cohort 1 and 2: 1. Change in stool form 2. Changes in symptoms of functional constipation 3. Changes in associated clinical symptoms of functional constipation 4. Average duration of action (from the time of consuming tablets to first bowel movement) 5. Global assessment of overall change as per the investigator and subject 6. Assessment of tolerability of study product as per the investigator and subject 7. Assessment of laboratory investigations (in cohort 1 only) Timepoint: Screening visit, Day 0, Day 7, Day 14 and Day 21 | — |
Primary
| Measure | Time frame |
|---|---|
| Cohort 1 and 2: Change in frequency of bowel movements from baseline visit to the end of the study visit and between the two groups Timepoint: Screening visit, Day 0, Day 7, Day 14 and Day 21 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd.
Outcome results
None listed