Botanical Tincture for Symptoms of Irritable Bowel Syndrome

NCT03923322 | Withdrawn Phase 2 FDA Drug

• 1 other identifier: TSH_Family Medicine_2018001
• Study Type: interventional
• Target: N/A
• Locations: 1 country
• Sites: 1

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).

Conditions

Irritable Bowel Syndrome Characterized by Constipation

Outcome Measures

Primary Outcomes (3)

• 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 Outcomes (3)

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

  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)

  12 week study

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

  12 week study

Study Arms (2)

Botanical Tincture

EXPERIMENTAL

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

Placebo

PLACEBO COMPARATOR

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

Interventions

Botanical Tincture DRUG

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.

Also known as: BT

Botanical Tincture

Placebo OTHER

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.

Placebo

Eligibility Criteria

• Age: 18 Years+
• Sex: all
• Healthy Volunteers: No
• Age Groups: Adult (18-64), Older Adult (65+)

You may qualify if:

• 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

You may not qualify if:

• 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.

Sponsors & Collaborators

• Stamford Hospital: lead

Study Sites (1)

Stamford Health

Stamford, Connecticut, 06902, United States

Location

Study Officials

• Marc Brodsky, MD

  Stamford Hospital

  PRINCIPAL INVESTIGATOR

Study Design

• Study Type: interventional
• Phase: phase 2
• Allocation: RANDOMIZED
• Masking: QUADRUPLE
• Who Masked: PARTICIPANT, CARE PROVIDER, INVESTIGATOR, OUTCOMES ASSESSOR
• Purpose: TREATMENT
• Intervention Model: PARALLEL
• Sponsor Type: OTHER
• Responsible Party: PRINCIPAL INVESTIGATOR
• PI Title: Director, Center for Integrative Medicine and Wellness

Model Details: Double-blinded randomized, placebo-controlled trial

Study Record Dates

• First Submitted: April 17, 2019
• First Posted: April 22, 2019
• Study Start: January 1, 2025
• Primary Completion: January 1, 2025
• Study Completion: January 1, 2025
• Last Updated: November 29, 2024

Record last verified: 2024-11

Data Sharing

• IPD Sharing: Will share
• Shared Documents: STUDY PROTOCOL, SAP, ICF, CSR, ANALYTIC CODE
• Time Frame: Data will be available after publication for unlimited time
• Access Criteria: Researcher

Locations

US (1)