Randomized Pilot Trial of Botanical Tincture for Symptoms of Irritable Bowel Syndrome Constipation Predominant (IBS-C) Diagnosed on ROME IV Criteria
试验速览
- 阶段
- 2 期
- 状态
- 撤回
- 入组人数
- 60
- 试验地点
- 1
- 主要终点
- Proportion of dosages of drug/placebo that are taken by participants
研究概览
简要总结
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).
详细描述
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.
研究设计
- 研究类型
- Interventional
- 分配方式
- Randomized
- 干预模型
- Parallel
- 主要目的
- Treatment
- 盲法
- Quadruple (Participant, Care Provider, Investigator, Outcomes Assessor)
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •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
排除标准
- •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.
研究组 & 干预措施
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.
干预措施: Botanical Tincture (Drug)
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.
干预措施: Placebo (Other)
结局指标
主要结局
Proportion of dosages of drug/placebo that are taken by participants
时间窗: 12 week study
At least 80% of dosages will be taken by participants
Number of subjects recruited
时间窗: 2 years
60 subjects
Proportion of subjects who complete the study
时间窗: 12 week study
At least 80% subjects will complete study
次要结局
- Bowel movement frequency: Number of Complete Spontaneous Bowel Movements (CSBMs) each week(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)(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)
研究者
Marc Brodsky
Director, Center for Integrative Medicine and Wellness
Stamford Hospital