Botanical Tincture for Symptoms of Irritable Bowel Syndrome

• Status: Not yet recruiting
• Trial end date: 2024-01-01
• Target enrollment: 0
• Participant gender: All

Summary

The main purpose of this study is to investigate the feasibility of a follow-up larger RCT on the efficacy of Botanical Tincture to relieve abdominal pain in people with Irritable Bowel Syndrome Constipation Predominant (IBS-C).

• Phase: Phase 2
• Accepts Healthy Volunteers?: No

Details

• Lead Sponsor: Stamford Hospital

Criteria

Inclusion Criteria:

• Patients meeting ROME IV criteria for the diagnosis of irritable bowel syndrome that requires that patients have had recurrent abdominal pain on average at least 1 day per week during the previous 3 months that is associated with 2 or more of the following :

• Related to defecation (may be increased or unchanged by defecation)

• Associated with a change in stool frequency

• Associated with a change in stool form or appearance

• Abdominal Pain Intensity: average of worst daily (in past 24 hours) abdominal pain score of >= 3 on a 0 to 10 point scale over last week

• Stool Frequency: < or = to 3 Complete Spontaneous Bowel Movement(CSBM) in the previous week

• Reported bloating rating > or = 2 on 5-point scale [0 (absent) - 4 (very severe)] in previous week

• English speakers, as all surveys are in English

Exclusion Criteria:

• Patients with known hypersensitivity to any component of the trial drugs

• History of eating disorders

• Patients with a history of diseases with abdominal symptoms that can resemble IBS

• Presence of any other known acute or chronic gastrointestinal disorder

• History of abdominal surgery (cholecystectomy and appendectomy can be tolerated when performed at least one year previously)

• Pregnancy or breast feeding

• Current or past history of alcohol dependence

• Based on lack of adequate scientific evidence to predict drug-drug interaction in vivo, current use of strong inhibitors or inducers for CYP enzymes and participants are instructed not to take any medications that are strong inhibitors or inducers for CYP enzymes during the course of the study

• Vulnerable Subjects. The study will not include vulnerable subjects (such as, those with limited autonomy or those in subordinate hierarchical positions). Children, pregnant women, nursing home residents or other institutionalized persons, students, employees, fetuses, prisoners, and persons with decisional incapacity will not be included.