Health Condition 1: K581- Irritable bowel syndrome with constipation
Conditions
Interventions
None listed
Sponsors
Tatvartha Health Pvt Ltd
IR Innovate Research PvtLtd
Eligibility
Inclusion criteria
Inclusion criteria: To be eligible for the study, Subjects must meet the following criteria 1.Healthy males and females aged 18–60 years. 2.Diagnosed with mild to severe functional constipation or IBS-C using Bristol stool scale. 3.Subjects willing to avoid fermented foods throughout the study duration. 4.No use of fiber supplementation over the month prior to the screening visit. 5.Able and willing to comply with the study protocol.
Exclusion criteria
Exclusion criteria: Subjects with any of the following symptoms will be excluded from the study: 1.Presence of significant gastrointestinal pathology, including but not limited to malignancies. 2.Subjects with IBS-D, IBD & IBS-M. 3.Active or recent esophageal disease, such as severe gastroesophageal reflux disease (GERD) or esophageal strictures and Crohn’s, Piles disease etc. 4.Diagnosed fatty liver disease or hepatic disorders. 5.Active gastrointestinal ulcers or the recent history of peptic or duodenal ulcers. 6.Skin disorders related to immune function, such as seborrheic dermatitis. 7.History of major gastrointestinal surgery within the past 6 months. 8.Recent use of prebiotics, probiotics, Ayurvedic medications, or other supplements for constipation that significantly affect gastrointestinal motility within 2 weeks prior to screening 9.Women who are pregnant, breastfeeding, or planning pregnancy during the study period. 10.Evidence of current or recent (within the last 3 months) drug or alcohol abuse. 11.Participation in any clinical trial involving investigational products within 3 months of screening. 12.Recent history of acute or chronic illness that may compromise immune function or overall health
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1. The change in constipation symptom severity from baseline to the end of the study period is assessed through a standardized constipation severity scale, comparing improvements in stool frequency, ease of bowel movements, and reduction in abdominal discomfort. (VAS Scale), 2. Time frame: T0, T7, T14, T21, T28Timepoint: Baseline (T0), Day 7 (T7), Day 14 (T14), Day 21 (T21), Day 28 (T28) | — |
Secondary
| Measure | Time frame |
|---|---|
| 1.Increase in the number of bowel movements per week from baseline to the end of the study period. 2.Improvement in stool consistency as measured by the Bristol Stool Chart, comparing baseline to weekly time points 3.Subjective reports of relief from constipation symptoms, including reduced straining, bloating, and abdominal discomfort, as recorded in weekly assessments. (PAC-SYM questionnaire) 4.The incidence and severity of any adverse events or side effects associated with the gut regime, recorded throughout the study duration. 5.Time frame: T0, T7, T14, T21, T28 Timepoint: Time frame: T0, T7, T14, T21, T28 | — |
Countries
India
Contacts
Public ContactDr Devesh Kumar
IR Innovate Research Pvt. Ltd
Outcome results
None listed