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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).
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.
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| Label | Type | Description | Intervention Names |
|---|---|---|---|
| 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. |
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| 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. |
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| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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 |
| Measure | Description | Time Frame |
|---|---|---|
| Abdominal Pain Intensity: weekly average of worst daily (in past 24 hours) abdominal pain score scale of 0 (No pain) -10 (Worst imaginable pain) | 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. | 12 week study |
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Inclusion Criteria:
Exclusion Criteria:
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| Name | Affiliation | Role |
|---|---|---|
| Marc Brodsky, MD | Stamford Hospital | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Stamford Health | Stamford | Connecticut | 06902 | United States |
IPD will be available from Marc Brodsky, MD
Data will be available after publication for unlimited time
Researcher
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Double-blinded randomized, placebo-controlled trial
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| 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. |
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| Abdominal Bloating Intensity: weekly average of worst daily (in past 24 hours) abdominal bloating rating on a scale of 0 (absent) - 4 (very severe) | 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 | 12 week study |
| Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week | A Stool Frequency Weekly Responder is defined as a patient who experiences an increase of at least one CSBM per week from baseline | 12 week study |