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.
Study Type
INTERVENTIONAL
Allocation
RANDOMIZED
Purpose
TREATMENT
Masking
QUADRUPLE
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.
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.
Stamford Health
Stamford, Connecticut, United States
Number of subjects recruited
60 subjects
Time frame: 2 years
Proportion of subjects who complete the study
At least 80% subjects will complete study
Time frame: 12 week study
Proportion of dosages of drug/placebo that are taken by participants
At least 80% of dosages will be taken by participants
Time frame: 12 week study
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.
Time frame: 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)
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
Time frame: 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
Time frame: 12 week study
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