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Botanical Tincture for Symptoms of Irritable Bowel Syndrome

The safety and scientific validity of this study is the responsibility of the study sponsor and investigators. Listing a study does not mean it has been evaluated by the U.S. Federal Government. Know the risks and potential benefits of clinical studies and talk to your health care provider before participating. Read our disclaimer for details.
 
ClinicalTrials.gov Identifier: NCT03923322
Recruitment Status : Not yet recruiting
First Posted : April 22, 2019
Last Update Posted : September 21, 2021
Sponsor:
Information provided by (Responsible Party):
Marc Brodsky, Stamford Hospital

Study Description
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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).

Condition or disease Intervention/treatment Phase
Irritable Bowel Syndrome Characterized by Constipation Drug: Botanical Tincture Other: Placebo Phase 2

Detailed Description:
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.
Study Design
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Study Type : Interventional  (Clinical Trial)
Estimated Enrollment : 60 participants
Allocation: Randomized
Intervention Model: Parallel Assignment
Intervention Model Description: Double-blinded randomized, placebo-controlled trial
Masking: Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
Primary Purpose: Treatment
Official Title: Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria
Estimated Study Start Date : December 2022
Estimated Primary Completion Date : December 2023
Estimated Study Completion Date : January 2024

Resource links provided by the National Library of Medicine

MedlinePlus related topics: Constipation

Arms and Interventions
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Arm Intervention/treatment
Experimental: Botanical Tincture
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
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.
Other Name: BT
Placebo Comparator: Placebo
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
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.


Outcome Measures
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Primary Outcome Measures :
  1. Number of subjects recruited [ Time Frame: 2 years ]
    60 subjects

  2. Proportion of subjects who complete the study [ Time Frame: 12 week study ]
    At least 80% subjects will complete study

  3. Proportion of dosages of drug/placebo that are taken by participants [ Time Frame: 12 week study ]
    At least 80% of dosages will be taken by participants


Secondary Outcome Measures :
  1. Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain) [ Time Frame: 12 week study ]
    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.

  2. Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe) [ Time Frame: 12 week study ]
    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

  3. Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week [ Time Frame: 12 week study ]
    A Stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline


Eligibility Criteria
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Ages Eligible for Study:   18 Years and older   (Adult, Older Adult)
Sexes Eligible for Study:   All
Accepts Healthy Volunteers:   No
Criteria

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.
Contacts and Locations
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Information from the National Library of Medicine

To learn more about this study, you or your doctor may contact the study research staff using the contact information provided by the sponsor.

Please refer to this study by its ClinicalTrials.gov identifier (NCT number): NCT03923322


Contacts
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Contact: Marc Brodsky, MD 203-276-4777 mbrodsky@stamhealth.org
Contact: Suzanne Rose, PhD 203-276-7866 srose@stamhealth.org

Locations
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United States, Connecticut
Stamford Health
Stamford, Connecticut, United States, 06902
Contact: Marc Brodsky, MD    203-276-4777    mbrodsky@stamhealth.org   
Contact: Suzanne Rose, PhD    203-276-7866    srose@stamhealth.org   
Sponsors and Collaborators
Stamford Hospital
Investigators
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Principal Investigator: Marc Brodsky, MD Stamford Hospital
More Information
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Responsible Party: Marc Brodsky, Director, Center for Integrative Medicine and Wellness, Stamford Hospital
ClinicalTrials.gov Identifier: NCT03923322    
Other Study ID Numbers: TSH_Family Medicine_2018001
First Posted: April 22, 2019    Key Record Dates
Last Update Posted: September 21, 2021
Last Verified: September 2021
Individual Participant Data (IPD) Sharing Statement:
Plan to Share IPD: Yes
Plan Description: IPD will be available from Marc Brodsky, MD
Supporting Materials: Study Protocol
Statistical Analysis Plan (SAP)
Informed Consent Form (ICF)
Clinical Study Report (CSR)
Analytic Code
Time Frame: Data will be available after publication for unlimited time
Access Criteria: Researcher

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Studies a U.S. FDA-regulated Drug Product: Yes
Studies a U.S. FDA-regulated Device Product: No
Additional relevant MeSH terms:
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Irritable Bowel Syndrome
Syndrome
Constipation
Disease
Pathologic Processes
Signs and Symptoms, Digestive
 Colonic Diseases, Functional
Colonic Diseases
Intestinal Diseases
Gastrointestinal Diseases
Digestive System Diseases