| Condition or disease | Intervention/treatment | Phase |
|---|---|---|
| Irritable Bowel Syndrome Characterized by Constipation | Drug: Botanical Tincture Other: Placebo | Phase 2 |
| 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 : | September 2020 |
| Estimated Primary Completion Date : | September 2022 |
| Estimated Study Completion Date : | January 2023 |
| Arm | Intervention/treatment |
|---|---|
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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.
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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
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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.
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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.
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| Ages Eligible for Study: | 18 Years and older (Adult, Older Adult) |
| Sexes Eligible for Study: | All |
| Accepts Healthy Volunteers: | No |
Inclusion Criteria:
Exclusion Criteria:
| Contact: Marc Brodsky, MD | 203-276-4777 | mbrodsky@stamhealth.org | |
| Contact: Suzanne Rose, PhD | 203-276-7866 | srose@stamhealth.org |
| 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 | |
| Principal Investigator: | Marc Brodsky, MD | Stamford Hospital |
| Tracking Information | |||||||||||||||||||
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| First Submitted Date ICMJE | April 17, 2019 | ||||||||||||||||||
| First Posted Date ICMJE | April 22, 2019 | ||||||||||||||||||
| Last Update Posted Date | March 18, 2020 | ||||||||||||||||||
| Estimated Study Start Date ICMJE | September 2020 | ||||||||||||||||||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
| Current Primary Outcome Measures ICMJE |
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| Original Primary Outcome Measures ICMJE |
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| Change History | |||||||||||||||||||
| Current Secondary Outcome Measures ICMJE |
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| Original Secondary Outcome Measures ICMJE | Same as current | ||||||||||||||||||
| Current Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
| Original Other Pre-specified Outcome Measures | Not Provided | ||||||||||||||||||
| Descriptive Information | |||||||||||||||||||
| Brief Title ICMJE | Botanical Tincture for Symptoms of Irritable Bowel Syndrome | ||||||||||||||||||
| Official Title ICMJE | Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria | ||||||||||||||||||
| 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). | ||||||||||||||||||
| 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 Type ICMJE | Interventional | ||||||||||||||||||
| Study Phase ICMJE | Phase 2 | ||||||||||||||||||
| Study Design ICMJE | 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 |
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| Condition ICMJE | Irritable Bowel Syndrome Characterized by Constipation | ||||||||||||||||||
| Intervention ICMJE |
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| Study Arms ICMJE |
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| Publications * | Not Provided | ||||||||||||||||||
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* Includes publications given by the data provider as well as publications identified by ClinicalTrials.gov Identifier (NCT Number) in Medline. |
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| Recruitment Information | |||||||||||||||||||
| Recruitment Status ICMJE | Not yet recruiting | ||||||||||||||||||
| Estimated Enrollment ICMJE |
60 | ||||||||||||||||||
| Original Estimated Enrollment ICMJE | Same as current | ||||||||||||||||||
| Estimated Study Completion Date ICMJE | January 2023 | ||||||||||||||||||
| Estimated Primary Completion Date | September 2022 (Final data collection date for primary outcome measure) | ||||||||||||||||||
| Eligibility Criteria ICMJE |
Inclusion Criteria:
Exclusion Criteria:
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| Sex/Gender ICMJE |
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| Ages ICMJE | 18 Years and older (Adult, Older Adult) | ||||||||||||||||||
| Accepts Healthy Volunteers ICMJE | No | ||||||||||||||||||
| Contacts ICMJE |
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| Listed Location Countries ICMJE | United States | ||||||||||||||||||
| Removed Location Countries | |||||||||||||||||||
| Administrative Information | |||||||||||||||||||
| NCT Number ICMJE | NCT03923322 | ||||||||||||||||||
| Other Study ID Numbers ICMJE | TSH_Family Medicine_2018001 | ||||||||||||||||||
| Has Data Monitoring Committee | No | ||||||||||||||||||
| U.S. FDA-regulated Product |
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| IPD Sharing Statement ICMJE |
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| Responsible Party | Marc Brodsky, Stamford Hospital | ||||||||||||||||||
| Study Sponsor ICMJE | Stamford Hospital | ||||||||||||||||||
| Collaborators ICMJE | Not Provided | ||||||||||||||||||
| Investigators ICMJE |
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| PRS Account | Stamford Hospital | ||||||||||||||||||
| Verification Date | March 2020 | ||||||||||||||||||
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ICMJE Data element required by the International Committee of Medical Journal Editors and the World Health Organization ICTRP |
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