- ICH GCP
- US Clinical Trials Registry
- Clinical Trial NCT01641224
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Study Overview
Status
Conditions
Detailed Description
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.
Study Type
Enrollment (Anticipated)
Phase
- Not Applicable
Contacts and Locations
Study Locations
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Beijing, China, 100050
- Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
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Shanghai, China, 200240
- Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
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Jiangsu
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Nanjing, Jiangsu, China, 210017
- Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
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Nanjing, Jiangsu, China, 210029
- Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
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Participation Criteria
Eligibility Criteria
Ages Eligible for Study
Accepts Healthy Volunteers
Genders Eligible for Study
Description
Inclusion Criteria:
- 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
Exclusion Criteria:
- 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
Study Plan
How is the study designed?
Design Details
- Primary Purpose: Treatment
- Allocation: Randomized
- Interventional Model: Parallel Assignment
- Masking: Double
Arms and Interventions
Participant Group / Arm |
Intervention / Treatment |
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Active Comparator: 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.
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Atractylodes (~10-15g)
Other Names:
Paeonia Lactiflora (~15-30g)
Other Names:
Tangerine Peel (~10g)
Other Names:
Ledebouriella Root (~10g)
Other Names:
Radix codonopsitis (~10-15g)
Other Names:
Radix curcumae (~10g)
Other Names:
Fingered citron (~10g)
Other Names:
Tuckahoe (15g)
Other Names:
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Active Comparator: Pinaverium
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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.
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Placebo Comparator: Placebo
Placebo is blindly given to patients
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Placebo is blindly given to patients.
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What is the study measuring?
Primary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs
Time Frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
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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)
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TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
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Secondary Outcome Measures
Outcome Measure |
Measure Description |
Time Frame |
---|---|---|
The side effect associated with the treatments
Time Frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
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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.
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TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
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Collaborators and Investigators
Sponsor
Investigators
- Principal Investigator: Jun Xiao, Ph.D., University of Minnesota
Publications and helpful links
General Publications
- 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.
Study record dates
Study Major Dates
Study Start
Primary Completion (Actual)
Study Completion (Anticipated)
Study Registration Dates
First Submitted
First Submitted That Met QC Criteria
First Posted (Estimate)
Study Record Updates
Last Update Posted (Estimate)
Last Update Submitted That Met QC Criteria
Last Verified
More Information
Terms related to this study
Keywords
Additional Relevant MeSH Terms
- Digestive System Diseases
- Pathologic Processes
- Disease
- Gastrointestinal Diseases
- Colonic Diseases, Functional
- Colonic Diseases
- Intestinal Diseases
- Syndrome
- Irritable Bowel Syndrome
- Physiological Effects of Drugs
- Molecular Mechanisms of Pharmacological Action
- Parasympatholytics
- Autonomic Agents
- Peripheral Nervous System Agents
- Membrane Transport Modulators
- Calcium-Regulating Hormones and Agents
- Calcium Channel Blockers
- Pinaverium
Other Study ID Numbers
- 1106E00524
This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.
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