A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
试验速览
- 阶段
- 不适用
- 发起方
- 入组人数
- 800
- 试验地点
- 4
- 主要终点
- Abdominal pain
研究概览
简要总结
The purpose of this study is to test the onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long term (over one year). Pinaverium has been in many countries, but there is no randomized, double-blind, large sample size, and placebo-controlled study on this medication yet. Tong Xie Yao Fang (Formula for pain and diarrhea) is a historically and contemporarily used traditional Chinese medicine that can be used for IBS. The hypothesis is that the two remedies are effective and safe for IBS treatment with no significant different onset and offset of actions when tested by modern clinical standards and criteria.
详细描述
Pinaverium bromide (pinaverium), an antispasmodics, is one of the most commonly used IBS medication worldwide. However, original clinical studies on pinaverium are scarce. Only five original clinical studies from Europe, one from Latin America, and one from Asian were found. These studies were single-centered and small sample sized (19 - 53 IBS patients) studies.
Tong Xie Yao Fang has long been used in China. Its efficacy and safety has not been evaluated by modern scientific method.
Effectiveness, onset and offset of actions are the most considered factors when physicians choose medications for IBS. Yet, to our knowledge, there are no clinical studies studied the onset and offset of actions of pinaverium, which remains one of the most transcribed IBS medications, and herbs, which are becoming more popular for treating IBS.
This study is designed to evaluate onset and offset of actions, efficacy, and safety over a long term (>1 year) of pinaverium and Tong Xie Yao Fang for IBS treatment in a double-blind, randomized, and large sample size clinical trial using placebo as a control.
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 (Participant, Investigator)
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
- •18 to 70 years old age group, male and female
- •In accordance with the above Western medicine Rome III standards.
- •In accordance with the above description of Deficient Spleen Qi and Liver Qi Stagnation
- •Informed consent for treatment
- •No change in appetite during treatments periods
排除标准
- •Pregnant or lactation female patients, and Fertility male patients
- •Present digestive system disease within current three months
- •Take IBS medicines within ten days prior to treatment or during treatment
- •Take depression medicine within ten days prior to treatment or during treatment
- •Take pain reliever medicine within ten days prior to treatment or during treatment
- •Have serious primary heart, liver, kidney, lung and blood system diseases, asthma, and Lung and liver dysfunction patients
- •If an emergency occurs; a physician terminates the treatment
- •Cannot comply with the rules and cannot cooperate
研究组 & 干预措施
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Atractylodes (Device)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Paeonia Lactiflora (Device)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Tangerine Peel (Device)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Ledebouriella Root (Drug)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Radix codonopsitis (Drug)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Radix curcumae (Drug)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Fingered citron (Drug)
TCM (Traditional Chinese medicine)
Formula for pain and diarrhea, Atractylodes (~10-15g), Paeonia Lactiflora (~15-30g), Tangerine Peel (~10g), Ledebouriella Root (~10g), Radix codonopsitis (~10-15g), Radix curcumae (~10g), Fingered citron (~10g), Tuckahoe (~15g), etc.
干预措施: Tuckahoe (Drug)
Pinaverium
干预措施: Pinaverium (Drug)
Placebo
Placebo is blindly given to patients
干预措施: Placebo (Drug)
结局指标
主要结局
Abdominal pain
时间窗: 2 years
0 = no pain, 10 worst pain
Primary endpoint --- vi) Form (appearance) of stool
时间窗: 2 years
Use Bristol stool scale.
次要结局
- Frequency of the pain(2 year)
- # of stools per day(2 years)
- Abdominal discomfort(2 years)
- Frequency of discomfort(2 years)