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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

Timeline

Screening 3 weeks

Treatment Varies

Follow Up 2 years

Awards & highlights

Study 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.Check my eligibility

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.See study design

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.

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

Outcome measures can provide a clearer picture of what you can expect from a treatment.

Primary outcome measures

Number of subjects recruited

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

Proportion of subjects who complete the study

Secondary outcome measures

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 / 4Eligibility criteria met

Find a Location

Who is running the clinical trial?

Stamford HospitalLead Sponsor

8 Previous Clinical Trials

3,366 Total Patients Enrolled

Marc Brodsky, MDPrincipal InvestigatorStamford Hospital

2 Previous Clinical Trials

78 Total Patients Enrolled

Media Library

Botanical Tincture (Botanical) Clinical Trial Eligibility Overview. Trial Name: NCT03923322 — Phase 2

Irritable Bowel Syndrome Research Study Groups: Botanical Tincture, Placebo

Irritable Bowel Syndrome Clinical Trial 2023: Botanical Tincture Highlights & Side Effects. Trial Name: NCT03923322 — Phase 2

Botanical Tincture (Botanical) 2023 Treatment Timeline for Medical Study. Trial Name: NCT03923322 — Phase 2

Frequently Asked Questions

These questions and answers are submitted by anonymous patients, and have not been verified by our internal team.

Are there any current openings for volunteers in this clinical trial?

"This particular clinical trial, as evidenced by clinicaltrials.gov, is not presently looking for candidates. The original posting was on December 1st, 2022 and the last edit was on October 26th, 2022. Although this specific trial isn't searching for participants right now, there are 1547 other trials that are."

Answered by AI

Has the federal government given its stamp of approval to Botanical Tincture?

"While there is some evidence supporting the safety of Botanical Tincture, it received a score of 2 because Phase 2 trials have yet to produce data verifying efficacy."

Answered by AI

Recent research and studies

clinicaltrials.govStudy

Botanical Tincture for Symptoms of Irritable Bowel Syndrome

Marc Brodsky 2023. "Botanical Tincture for Symptoms of Irritable Bowel Syndrome". ClinicalTrials.gov. https://clinicaltrials.gov/ct2/show/NCT03923322.

All > Irritable Bowel Syndrome > Ibs