Health Condition 1: K581- Irritable bowel syndrome with constipation
Conditions
Interventions
None listed
Sponsors
Apex Laboratories Private Limited
Eligibility
Inclusion criteria
Inclusion criteria: 1. Participants of either sex with age between 18 years and 65 years. 2. Diagnosis of IBS as per Rome IV criteria with following symptoms for more than 3 months. Abdominal discomfort such as mild pain, cramping, bloating Altered bowel habit indicated by frequent constipation Functional dyspepsia 3. Able and willing to give written informed consent. 4. Women of childbearing potential must be willing to practice an acceptable method of contraception throughout the study. 5. Willingness and ability to comply with all study procedures, visit schedules, and follow-up assessments.
Exclusion criteria
Exclusion criteria: 1. Pregnant, breastfeeding, or planning pregnancy during the study. 2. Uncontrolled diabetes, hypertension, symptomatic congestive heart failure, unstable angina pectoris, myocardial infarction. 3. On antibiotics or laxatives within the preceding 6 weeks. 4. Presence of inflammatory bowel disease, acute GI tract infection. 5. Presence of fever, abdominal mass, signs of bowel obstruction. 6. History of colon cancer or diverticulitis. 7. Participated in another clinical drug trial within 3 months before recruitment. 8. Currently active alcohol or drug abuse or history of alcohol or drug abuse within 24 weeks prior to Baseline.
Design outcomes
Primary
| Measure | Time frame |
|---|---|
| 1.Change in IBS Symptom Severity Change in total IBS Symptom Severity Scale (IBS-SSS) score from Baseline to Day 30. Evaluates improvement in abdominal pain, bloating, stool pattern, and overall discomfort. Reduction of greater than or equal to 50 points indicates clinically meaningful improvement. 2. Change in Stool Frequency Change in the mean number of spontaneous bowel movements (SBMs) per week from Baseline to Day 30, based on the participant s stool diary.Timepoint: Visit 1 - Day 0 Visit 2 - Day 15 2 days Visit 3 - Day 30 2 days | — |
Secondary
| Measure | Time frame |
|---|---|
| Change in IBS Quality of Life Questionnaire (IBS-QoL-36) score Change in IBS Quality of Life Questionnaire (IBS-QoL-36) score from Baseline to Day 30. Measures improvement in emotional, social, & physical well-being. A higher score indicates improvement in overall health-related quality of life. Participant s overall perception of improvement at Day 30 compared with Baseline.Timepoint: Visit 1 - Day 0 Visit 2 - Day 15 2 days Visit 3 - Day 30 2 days | — |
Countries
India
Contacts
Public ContactMs Mamatha B Gokavi
Samahitha Research Solutions
Outcome results
None listed