An interventional study of Pinaverium and Atractylodes in Irritable Bowel Syndrome, sponsored by University of Minnesota. Status unknown at 4 sites in China. Open to participants aged 18 Years to 70 Years. Per ClinicalTrials.gov, last updated 2014-05-12.
Sponsored by University of Minnesota · Not applicable, Interventional, and Treatment
The purpose of this study is to test the efficacy and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS). 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 when tested by modern clinical standards and criteria.
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.
This study is designed to evaluate the efficacy and safety 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.
1,062 studies on the registry are indexed under Irritable Bowel Syndrome; 190 are open to participants now.
This study's planned enrollment of 800 is above the median of 71 across 853 interventional studies indexed under Irritable Bowel Syndrome.
Browse Irritable Bowel Syndrome studies →University of Minnesota is the lead sponsor of 1,184 studies on the registry; 195 are open to participants now.
Of its 132 completed or terminated interventional studies of FDA-regulated products, 91 (69%) have results posted.
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Exclusion Criteria:
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.
Device: Atractylodes · Device: Paeonia Lactiflora · Device: Tangerine Peel · Drug: Ledebouriella Root · Drug: Radix codonopsitis · Drug: Radix curcumae · Drug: Fingered citron · Drug: Tuckahoe
Drug: Pinaverium
Placebo is blindly given to patients
Drug: Placebo
To test the effectiveness and safety of the formula for pain and diarrhea, we will randomly assign patients into one 3 groups: Pinaverium, TCM (Formula for pain and diarrhea) group, and placebo group, and treat them accordingly.
Atractylodes (\~10-15g)
Also known as: One of active ingredients in TCM group
Paeonia Lactiflora (\~15-30g)
Also known as: One of active ingredients in TCM group
Tangerine Peel (\~10g)
Also known as: One of active ingredients in TCM group
Ledebouriella Root (\~10g)
Also known as: One of active ingredients in TCM group
Radix codonopsitis (\~10-15g)
Also known as: One of active ingredients in TCM group
Radix curcumae (\~10g)
Also known as: One of active ingredients in TCM group
Fingered citron (\~10g)
Also known as: One of active ingredients in TCM group
Tuckahoe (15g)
Also known as: One of active ingredients in TCM group
Placebo is blindly given to patients.
The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs
The parameters used to evaluate the effectiveness of the drugs included i) Abdominal pain (0 = no pain, 1 = mild pain, 2 = moderate pain, 3 = severe pain); ii) Frequency of the pain (# of pains per day); iii) Abdominal discomfort (0 = No discomfort,1 = mild,2 = moderate,3 = severe); iv) Frequency of discomfort (# of discomfort per day); v) # of stools per day; vi) Form (appearance) of stool (0 = Normal,1 = soft pieces with clear-cut edges,2 = mushy,3 = watery)
Time frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
The side effect associated with the treatments
The following will be documented: constipation, headache, dizzy, hypertension, chest pain, abdominal pain, flatus, anxiety, insomnia, nausea, fever, fatigue, muscle pain, urinary infection, respiratory tract infection, Others.
Time frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
This study is status unknown, as verified in May 2014. You cannot join it, but the record below documents what was studied.
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