A Phase I, Double-Blind, Placebo-Controlled, Randomized, Parallel-Group Study to Evaluate the Safety and Efficacy of a Combination Herbal Therapy (CHT), Versus Placebo in Improving the Overall Quality of Life and Symptoms in Patients With Irritable Bowel Syndrome (IBS)
试验速览
- 阶段
- 1 期
- 状态
- 已完成
- 入组人数
- 100
- 试验地点
- 2
- 主要终点
- To evaluate whether CHT administered orally (PO) induces a change in the overall QOL score from baseline values at 4 weeks of treatment measured via the IBS 36 questionnaire in patients with irritable bowel syndrome, relative to placebo
研究概览
简要总结
This is an 8-week double-blind, placebo-controlled, randomized, parallel-group study with an additional two week baseline observation period to evaluate the safety of combination herbal therapy (CHT) versus placebo and short and long-term efficacy in terms of improved IBS, overall quality of life (QOL) and symptomatology.
详细描述
Background:
IBS (Irritable Bowel Syndrome) is a disorder of motility of the entire GI tract that produces cramping, abdominal pain, constipation, and/or diarrhea and sometimes passing of mucus in bowel movements. In most people with IBS, the GI tract is highly sensitive to many stimuli, including diet and distension from gas. Among dietary suspects are high-fat or other high-calorie meals, dairy products, wheat, citrus fruits, coffee, and tea which can trigger spasms of the colon muscle. During an episode, GI tract contractions become stronger and more frequent, and the resulting rapid motility may lead to diarrhea. When colon motility is reduced, bowel movements do not occur regularly, resulting in constipation. Cramping appears to be induced by strong contractions and increased sensitivity of pain receptors in the large intestine. IBS can be triggered or intensified by stress due to communications between the central nervous system and the nervous system of the small and large intestines. This is sometimes referred to as a brain-gut connection and is supported by inspection of electroencephalogram (EEG) traces which showed significantly greater EEG abnormality in IBS patients (29.2%) than in controls (4.2%) [p<0.02]. The degree of abnormality was positively correlated with colonic motility only in IBS patients (p<0.05) allowing the authors to conclude that there is an electrophysiologic brain-gut interaction in IBS.
IBS can cause great physical discomfort and embarrassment to many of its sufferers, but is not life threatening.
There is no current consensus as to an organic cause of this syndrome and there generally appears to be no sign of disease upon physical examination except for tenderness over the large intestine. The diagnosis is symptom-based, usually through identification of the ROME II criteria for IBS. These criteria which have been accepted worldwide by clinicians and researchers as the standard for IBS diagnosis are as follows: At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain that has two of three features:
- Relieved with defecation; and/or
- Onset associated with a change in frequency of stool; and/or
- Onset associated with a change in form (appearance) of stool.
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
- Double
入排标准
- 年龄范围
- 18 Years 至 70 Years（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Men or women aged 18-70
- •Diagnosis of irritable bowel syndrome based on the following criteria (ROME II): At least 12 weeks, which need not be consecutive, in the preceding 12 months of abdominal discomfort or pain (at least once per week) with at least 2 of the following features:
- •Relief with defecation;
- •Onset associated with a change in stool frequency;
- •Onset associated with a change in stool consistency.
- •At least two of the following on at least 25% of occasions or days in the last 3 months:
- •Fewer than three bowel movements a week;
- •More than three bowel movements a day;
- •Hard or lumpy stools;
- •Loose (mushy) or watery stools;
- •Straining during a bowel movement;
- •Feeling of incomplete bowel movement;
- •Passing mucus during a bowel movement;
- •Abdominal fullness, bloating or swelling.
- •Women of childbearing potential must be using an acceptable method of contraception.
排除标准
- •History of severe or intractable IBS, defined as continuous, unremitting and severe abdominal pain greater than 12 hours/day
- •Concurrent diagnosis of any bowel disturbance that would interfere with the assessment or safety of the study
- •History of laxative abuse
- •Previous abdominal surgery (uncomplicated appendectomy, hysterectomy or cholecystectomy at least 6 months prior to entry acceptable)
- •History of metabolic or inflammatory disease that may affect bowel motility, eg., inflammatory bowel disease, diabetes mellitus, sarcoidosis
- •Use of the following concomitant medications: medications that can affect gastrointestinal (GI) motility; other investigational drug use (30 day "washout" required); medications affecting visceral perception; antidepressants; selective serotonin reuptake inhibitors; opioids; narcotic analgesics; antispasmodic and anticonvulsant agents; insulin or other hypoglycemic therapy; thyroid hormones; central nervous system (CNS) depressants.
- •Other significant illness as determined by Investigator
- •Pregnancy
- •History of drug or alcohol abuse within 2 years
- •Insufficient knowledge of English or Hebrew to complete self-assessments to participate in study
- •Any other reason for which Investigator feels that subject's compliance is at question or safety may be compromised.
结局指标
主要结局
To evaluate whether CHT administered orally (PO) induces a change in the overall QOL score from baseline values at 4 weeks of treatment measured via the IBS 36 questionnaire in patients with irritable bowel syndrome, relative to placebo
次要结局
- 30% change on the IBS-36 from baseline to 4 weeks ("no" or "yes")
- Change on IBS-36 from 4 weeks (last treatment taken) and 8 weeks (i.e., after 4 weeks of "washout")
- Change in IBS symptoms severity score from baseline to 4 weeks
- Change in IBS symptoms severity score from 4 to 8 weeks