Clinical trial NCT03923322: Botanical Tincture for Symptoms of Irritable Bowel Syndrome
Official title: Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria
Study type: INTERVENTIONAL
Overall status: WITHDRAWN
Phase: PHASE2
Conditions: Irritable Bowel Syndrome Characterized by Constipation
Lead sponsor: Stamford Hospital
Sponsor class: OTHER
First posted: 2019-04-22
Enrollment: 0
Sex: ALL
Minimum age (years): 18
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Intervention model description: Double-blinded randomized, placebo-controlled trial
Primary purpose: TREATMENT

Brief 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).

Detailed description: The randomized pilot trial will address subject recruitment, retention, and subject compliance with protocol. A secondary is to learn if people with IBS-C are able to tolerate Botanical Tincture and the effect of taking Botanical Tincture on abdominal pain, bloating, and bowel movements.

Eligibility 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.

Primary outcomes:
measure: Number of subjects recruited
timeFrame: 2 years
measure: Proportion of subjects who complete the study
timeFrame: 12 week study
measure: Proportion of dosages of drug/placebo that are taken by participants
timeFrame: 12 week study
Secondary outcomes:
measure: Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain)
timeFrame: 12 week study
measure: Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe)
timeFrame: 12 week study
measure: Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week
timeFrame: 12 week study
Other outcomes:
Locations:
city: Stamford
country: United States
facility: Stamford Health
state: Connecticut
Study officials:
affiliation: Stamford Hospital
name: Marc Brodsky, MD
role: PRINCIPAL_INVESTIGATOR
References: