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Botanical

Botanical Tincture for Irritable Bowel Syndrome

Phase 2

Waitlist Available

Led By Marc Brodsky, MD

Research Sponsored by Stamford Hospital

Eligibility Criteria Checklist

Specific guidelines that determine who can or cannot participate in a clinical trial

Must have

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

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

Must not have

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.

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Summary

This trial is testing if a botanical tincture can relieve abdominal pain for people with IBS-C.

Who is the study for?

This trial is for adults with Irritable Bowel Syndrome Constipation Predominant (IBS-C) who experience significant abdominal pain and bloating, have infrequent bowel movements, and meet specific diagnostic criteria. Excluded are those with a history of certain abdominal surgeries, vulnerable populations, other gastrointestinal disorders, pregnancy or breastfeeding women, alcohol dependence history, known drug sensitivities or taking strong CYP enzyme inhibitors/inducers.

What is being tested?

The study tests the effectiveness of a Botanical Tincture compared to a placebo in relieving abdominal pain in IBS-C patients. Participants will be randomly assigned to receive either the tincture or placebo to assess improvements in symptoms.

What are the potential side effects?

While not explicitly listed for this botanical tincture trial, potential side effects may include digestive discomforts such as nausea or diarrhea. Allergic reactions could occur if sensitive to any ingredients.

Eligibility Criteria

Inclusion Criteria

You may be eligible if you check “Yes” for the criteria below

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My worst daily abdominal pain in the last week averages 3 or more on a scale of 0 to 10.

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I have been diagnosed with IBS based on having abdominal pain at least once a week for the last 3 months, which is related to bowel movements and changes in stool.

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I've had 3 or fewer bowel movements last week.

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I have experienced significant bloating in the past week.

Exclusion Criteria

You may be eligible for the trial if you check “No” for criteria below:

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I am not currently taking strong CYP enzyme inhibitors or inducers.

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I am not considered a vulnerable subject as defined by the study.

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I have a known gastrointestinal disorder.

Timeline

Screening ~ 3 weeks3 visits

Treatment ~ Varies

Follow Up ~ 2 years

Screening ~ 3 weeks

Treatment ~ Varies

Follow Up ~2 years

This trial's timeline: 3 weeks for screening, Varies for treatment, and 2 years for reporting.

Treatment Details

Study Objectives

Study objectives can provide a clearer picture of what you can expect from a treatment.

Primary study objectives

Number of subjects recruited

Proportion of dosages of drug/placebo that are taken by participants

Proportion of subjects who complete the study

Secondary study objectives

Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe)

Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain)

Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week

Trial Design

2Treatment groups

Experimental Treatment

Placebo Group

Group I: Botanical TinctureExperimental Treatment1 Intervention

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.

Group II: PlaceboPlacebo Group1 Intervention

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.

0 / 7Eligibility criteria met