A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
NCT ID: NCT01641224
Last Updated: 2014-05-12
Study Results
The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.
Basic Information
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UNKNOWN
NA
800 participants
INTERVENTIONAL
2012-05-31
2014-05-31
Brief Summary
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Detailed Description
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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.
Conditions
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Study Design
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RANDOMIZED
PARALLEL
TREATMENT
DOUBLE
Study Groups
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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.
Atractylodes
Atractylodes (\~10-15g)
Paeonia Lactiflora
Paeonia Lactiflora (\~15-30g)
Tangerine Peel
Tangerine Peel (\~10g)
Ledebouriella Root
Ledebouriella Root (\~10g)
Radix codonopsitis
Radix codonopsitis (\~10-15g)
Radix curcumae
Radix curcumae (\~10g)
Fingered citron
Fingered citron (\~10g)
Tuckahoe
Tuckahoe (15g)
Pinaverium
Pinaverium
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.
Placebo
Placebo is blindly given to patients
Placebo
Placebo is blindly given to patients.
Interventions
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Pinaverium
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
Atractylodes (\~10-15g)
Paeonia Lactiflora
Paeonia Lactiflora (\~15-30g)
Tangerine Peel
Tangerine Peel (\~10g)
Ledebouriella Root
Ledebouriella Root (\~10g)
Radix codonopsitis
Radix codonopsitis (\~10-15g)
Radix curcumae
Radix curcumae (\~10g)
Fingered citron
Fingered citron (\~10g)
Tuckahoe
Tuckahoe (15g)
Placebo
Placebo is blindly given to patients.
Other Intervention Names
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Eligibility Criteria
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Inclusion Criteria
* 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
Exclusion Criteria
* 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
18 Years
70 Years
ALL
No
Sponsors
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University of Minnesota
OTHER
Responsible Party
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Principal Investigators
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Jun Xiao, Ph.D.
Role: PRINCIPAL_INVESTIGATOR
University of Minnesota
Locations
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Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
Nanjing, Jiangsu, China
Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
Beijing, , China
Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
Shanghai, , China
Countries
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References
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Wang Y, Fan H, Qi X, Lai Y, Yan Z, Li B, Tang M, Huang D, Li Z, Chen H, Zhu Q, Luo C, Chen X, Fen J, Jiang Z, Zheng L, Liu X, Tang Q, Zuo D, Ye J, Yang Y, Huang H, Tang Z, Lu W, Xiao J; Pharm D for the China Irritable Bowel Syndrome Consortium. Are personalized tongxie formula based on diagnostic analyses more effective in reducing IBS symptoms?-A randomized controlled trial. Complement Ther Med. 2018 Oct;40:95-105. doi: 10.1016/j.ctim.2018.07.002. Epub 2018 Aug 8.
Fan H, Zheng L, Lai Y, Lu W, Yan Z, Xiao Q, Li B, Tang M, Huang D, Wang Y, Li Z, Mei Y, Jiang Z, Liu X, Tang Q, Zuo D, Ye J, Yang Y, Huang H, Tang Z, Xiao J; China Irritable Bowel Syndrome Consortium. Tongxie Formula Reduces Symptoms of Irritable Bowel Syndrome. Clin Gastroenterol Hepatol. 2017 Nov;15(11):1724-1732. doi: 10.1016/j.cgh.2017.06.026. Epub 2017 Jun 17.
Zheng L, Lai Y, Lu W, Li B, Fan H, Yan Z, Gong C, Wan X, Wu J, Huang D, Wang Y, Mei Y, Li Z, Jiang Z, Liu X, Ye J, Yang Y, Huang H, Xiao J. Pinaverium Reduces Symptoms of Irritable Bowel Syndrome in a Multicenter, Randomized, Controlled Trial. Clin Gastroenterol Hepatol. 2015 Jul;13(7):1285-1292.e1. doi: 10.1016/j.cgh.2015.01.015. Epub 2015 Jan 26.
Other Identifiers
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1106E00524
Identifier Type: -
Identifier Source: org_study_id
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