None listed
Conditions
Interventions
Intervention1: CaFi (Branded ingredient): Dosage: 1 Tablet at bedtime with water for a period of 14 days. Participants will be asked to stop given medication after 14 days and will be followed for nex
Sponsors
Target Institute of Medical Education and Research Pvt. Ltd.
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants presenting with two or more of the Rome IV diagnostic criteria for Functional constipation, 2016 for the last 3 months with symptom onset at least 6 months prior to screening 2. Participants 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: 1. Participants diagnosed with colonic inertia. 2. Participants who have recently undergone abdominal surgery 3. Participants with history of ano-rectal surgery 4. Participants having other functional gastrointestinal disorders other than Functional constipation (i.e., IBS, Belching disorders etc.) 5. Participants diagnosed with structural abnormalities of the anal or rectal organs 6. Participants with uncontrolled DM and Hypertension 7. Known cases of HIV, Tuberculosis, Hypo and Hyperthyroidism 8. Known cases of Renal or Liver dysfunction. 9. Participants diagnosed with any neurological problems like Parkinson’s disease, Multiple sclerosis, Sacral nerve damage (prior pelvic surgery, tumor), Paraplegia, Autonomic neuropathy 10. Participants on chronic medication (greater than 60 days) and/or who are on medications known to cause constipation. 11. Pregnant or lactating females 12. Participants allergic to any of the ingredients of the study medications 13. Other conditions, which in the opinion of the investigators make the patient unsuitable for enrolment or could, interfere in adherence to of the study protocol
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| Change in weekly frequency of bowel movementsTimepoint: Screening Visit (Up to 3 days), Baseline (Day 0), Day 7, day 14, Day 21 | — |
Secondary
| Measure | Time frame |
|---|---|
| 1. Change in stool form on Bristol stool form scale 2. Changes in symptoms of irregular bowel habits including straining on defecation, sensation of incomplete evacuation, sensation of anorectal blockage, manual maneuvers required & average time spent for bowel evacuation on graded scale 3. Changes in associated symptoms including headache, belching, flatulence, abdominal distension or bloating, acidity on graded scale 4. Global assessment of overall change as per the investigator and subject 5. Assessment of tolerability of study product as per the investigator and subject by assessing Adverse Events 6. Assessment of laboratory investigations Timepoint: Screening Visit (Up to 3 days), Baseline (Day 0), Day 7, day 14, Day 21 | — |
Countries
India
Contacts
Public ContactDr Sanjay Tamoli
Target Institute of Medical Education and Research Pvt. Ltd
Outcome results
None listed