Botanical Tincture for Irritable Bowel Syndrome

Recruiting in Palo Alto (17 mi)

Overseen byMarc Brodsky, MD

Age: 18+

Sex: Any

Travel: May Be Covered

Time Reimbursement: Varies

Trial Phase: Phase 2

Waitlist Available

Sponsor: Stamford Hospital

Prior Safety Data

Trial Summary

What is the purpose of this trial?

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).

Eligibility Criteria

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.

Inclusion Criteria

English speakers, as all surveys are in English

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

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.

See 2 more

Exclusion Criteria

I have a history of diseases with symptoms similar to IBS.

You have had problems with alcohol in the past or currently struggle with alcohol addiction.

You have allergies to any of the ingredients in the trial drugs.

See 6 more

Treatment Details

Interventions

Botanical Tincture (Botanical)
Placebo (Other)

Trial OverviewThe 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.

Participant Groups

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.