Botanical Tincture for Symptoms of Irritable Bowel Syndrome

Study Overview
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Brief Summary
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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
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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.

Official Title
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Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria

Conditions
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Irritable Bowel Syndrome Characterized by Constipation

Intervention / Treatment
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* Drug: Botanical Tincture
* Other: Placebo


Participation Criteria
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Eligibility Criteria
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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.

Ages Eligible for Study
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Minimum Age: 18 Years

Sexes Eligible for Study
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All

Accepts Healthy Volunteers
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No

Study Plan
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How is the study designed?
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Design Details

Primary Purpose: Treatment
Allocation: Randomized
Intervention Model: Parallel Assignment
Interventional Model Description: Double-blinded randomized, placebo-controlled trial
Masking: Quadruple


Arms and Interventions

| Participant Group/Arm | Intervention/Treatment |
| --- | --- |
| Experimental: Botanical Tincture<br>The 12-week study includes a 2-week screening, 8-week treatment, and 2-week withdrawal periods. A 2-week screening period will be used to establish the presence and persistence of trial entry criteria and train patients in the mode of data collection. Participants randomly assigned to the Botanical Tincture arm at Week 2 will take 2.5 ml by mouth once a day at any time during the day that they choose. Participants who received Botanical Tincture during the study will be followed by a 2-week randomized withdrawal design to address the need for maintenance treatment to prevent sign or symptom recurrence. The participant will be randomly reassigned to receive either Botanical Tincture or placebo at a dosage of 2.5 ml once a day by mouth at any time during the day that they prefer. | Drug: Botanical Tincture<br>* Study participants will meet with the Investigator at baseline and week 2, 6, and 10 after the study period begins. Trial continuation criteria at 2 weeks after the start of the study includes abdominal pain intensity and stool frequency. Participants randomized to Botanical Tincture will have a 2-week withdrawal period. On the visits study participants may expect to be asked about epidemiologic information, IBS medications, IBS Quality of Life survey instruments, and daily diary of pain scale, bloating scale, and number of bowel movements.<br>* Other names: BT;|
| Placebo Comparator: Placebo<br>Participants randomly assigned to placebo arm at Week 2 will take 2.5 ml by mouth once a day at any time during the day that they choose during the 8-week treatment period. | Other: Placebo<br>* Study participants will meet with the Investigator at baseline and week 2, 6, and 10 after the study period begins. Trial continuation criteria at 2 weeks after the start of the study includes abdominal pain intensity and stool frequency. On the visits study participants may expect to be asked about epidemiologic information, IBS medications, IBS Quality of Life survey instruments, and daily diary of pain scale, bloating scale, and number of bowel movements.<br>|

What is the study measuring?
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Primary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Number of subjects recruited | 60 subjects | 2 years | 
| Proportion of subjects who complete the study | At least 80% subjects will complete study | 12 week study | 
| Proportion of dosages of drug/placebo that are taken by participants | At least 80% of dosages will be taken by participants | 12 week study | 

Secondary Outcome Measures

| Outcome Measure | Measure Description | Time Frame |
| --- | --- | --- |
| Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain) | An Abdominal Pain Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average of worst abdominal pain in the past 24 hours score (measured daily) of at least 30% compared with baseline weekly average. | 12 week study | 
| Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe) | A Bloating Intensity Weekly Responder is defined as a patient who experiences a decrease in the weekly average of worst bloating pain in the past 24 hours score (measured daily) of at least 30% compared with baseline weekly average | 12 week study | 
| Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week | A Stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline | 12 week study |