Health Condition 1: null- Constipation
Conditions
Interventions
Intervention1: Test Product: To be taken just before food (preferably with lunch and dinner) twice a day for 21 Days. Investigational product presented in sachets can be reconstituted (in one glass {a
Sponsors
ITC Limited
Karmic Lifesciences
Eligibility
Inclusion criteria
Inclusion criteria: 1. Males or females aged from 18 to 65 years, both inclusive. 2. Subjects with active symptoms of abdominal pain or discomfort. 3. IBS diagnosed by Rome III criteria: 4. Functional Constipation diagnosed by Rome III criteria: 5. Females of child-bearing potential should be willing to use adequate methods of contraception. 6. Subjects willing to provide a written and recorded informed consent 7. Subjects with no regular use of fibre supplementation (e.g. Fybogel, Lactulose) over the week prior to the screening visit.
Exclusion criteria
Exclusion criteria: 1. Major gastrointestinal complication (e.g. Crohns disease, ulcer, cancer). 2. The subject has a serious, unstable medical condition, such as lung disease, uncontrolled blood pressure, uncontrolled thyroid function, a physical or medical disability or an advanced medical condition. 3. The subject has been treated for a malignancy within the last 5 years (except BCC or SCC skin cancer). 4. The subject had previous significant gastric or intestinal surgery (except appendectomy and gall bladder surgery). 5. IBS subtype other than IBS associated with Constipation. 6. Diarrhoea (more than 3 bowel movements per day). 7. Consumption of probiotics or prebiotics within 2 weeks of randomization. 8. Antibiotic use within 4 weeks of randomization. 9. Laxative or other constipation medication use within 2 weeks of randomization. 10. Subjects on the ongoing therapies with the drugs known to effect gut motility (e.g. laxatives, prokinetics, etc). 11. Consumption of IBS medications, anti-depressants, pain reliever medications within ten days prior to treatment or during treatment. 12. Subject with eating disorder. 13. Known allergies to any substance in the study product, including lactose intolerance and galactosemia. 14. Pregnant or lactating women. 15. History of alcohol, drug, or medication abuse. 16. Participation in another study with any investigational product (IP) within 3 months of randomization. 17. Subject with any condition that might interfere with the conduct of the study as per Investigators opinion.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Mean reduction of Colonic Transit, Colonic Geometric Center at 24 hours between the groups by Scintigraphy as compared to baselineTimepoint: 24 hours | — |
Secondary
| Measure | Time frame |
|---|---|
| Assessment of safety in terms of incidence of treatment emergent adverse eventsTimepoint: From baseline to day 4, day 9, Day 16, Day 24 and Day 38;Change in Colonic FillingTimepoint: 6 hours;Change in ease of Stool passage between the groupsTimepoint: baseline to Day 9, Day 16, Day 24 and Day 38;Change in fecal microflora using stool culture between the groupsTimepoint: from baseline to Day 16, Day 24 and Day 38;Change in Half Time (t½) of Gastric Emptying of SolidsTimepoint: 0,1,2 Hours;Change in Investigatorâ??s Assessment on abdominal symptoms using a 5-point Likert scale between the groupsTimepoint: baseline to Day 9, Day 16, Day 24 and Day 38;Change in number of stool frequency between the groupsTimepoint: baseline to Day 9, Day 16, Day 24 and Day 38;Change in quality of life using Quality of Life (QoL) questionnaire between the groupsTimepoint: from baseline to Day 9, Day 16, Day 24 and Day 38;Change in stool consistency using the 7-point Bristol Stool Form Scale (BSFS) between the groupsTimepoint: baseline to Day 9, Day 16, Day 24 and Day 38;Change in Subjectâ??s Assessment on abdominal symptoms (using a 5-point Likert scale between the groups.Timepoint: baseline to Day 9, Day 16, Day 24 and Day 38;Correlation between QoL Questionnaire and GI Transit [Colonic Geometric Center, Colonic filling at 6 hours (%) and Gastric emptying half-life (t½) (min)] between the groupsTimepoint: at baseline and Day 24;Relief from abdominal symptoms between the groups by Subject Global Assessment of Relief using a 5-point Likert scaleTimepoint: baseline to Day 4, Day 9, Day 16, Day 24 and Day 38 | — |
Countries
India
Contacts
Public ContactDr Simran Sethi
Bhatia Hospital
Outcome results
None listed