Botanical Tincture for Symptoms of Irritable Bowel Syndrome (NCT03923322) | Clinical Trial Compass
WithdrawnPhase 2
Botanical Tincture for Symptoms of Irritable Bowel Syndrome
Stopped: Budget limitations
United States0Started 2025-01
Plain-language 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).
Who can participate
Age range18 Years
SexALL
See this in plain English?
AI-rewrites the medical criteria so a patient or caregiver can understand them. Always confirm with the trial site.
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 a…
What they're measuring
1
Number of subjects recruited
Timeframe: 2 years
2
Proportion of subjects who complete the study
Timeframe: 12 week study
3
Proportion of dosages of drug/placebo that are taken by participants