Back to resultsA Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Primary Purpose
Irritable Bowel Syndrome
Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pinaverium
Atractylodes
Paeonia Lactiflora
Tangerine Peel
Ledebouriella Root
Radix codonopsitis
Radix curcumae
Fingered citron
Tuckahoe
Placebo
Sponsored by
About this trial
This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)
Eligibility Criteria
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
Sites / Locations
- Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
- Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
- Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
- Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
Arms of the Study
Arm 1
Arm 2
Arm 3
Arm Type
Active Comparator
Active Comparator
Placebo Comparator
Arm Label
TCM (Traditional Chinese medicine)
Pinaverium
Placebo
Arm Description
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.
Placebo is blindly given to patients
Outcomes
Primary Outcome Measures
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)
Secondary Outcome Measures
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.
Full Information
1. Study Identification
Unique Protocol Identification Number
NCT01641224
Brief Title
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Official Title
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Study Type
Interventional
2. Study Status
Record Verification Date
May 2014
Overall Recruitment Status
Unknown status
Study Start Date
May 2012 (undefined)
Primary Completion Date
May 2013 (Actual)
Study Completion Date
May 2014 (Anticipated)
3. Sponsor/Collaborators
Responsible Party, by Official Title
Sponsor
Name of the Sponsor
University of Minnesota
4. Oversight
Data Monitoring Committee
Yes
5. Study Description
Brief Summary
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.
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.
6. Conditions and Keywords
Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)
7. Study Design
Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Anticipated)
8. Arms, Groups, and Interventions
Arm Title
TCM (Traditional Chinese medicine)
Arm Type
Active Comparator
Arm Description
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.
Arm Title
Pinaverium
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is blindly given to patients
Intervention Type
Drug
Intervention Name(s)
Pinaverium
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Atractylodes
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Atractylodes (~10-15g)
Intervention Type
Device
Intervention Name(s)
Paeonia Lactiflora
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Paeonia Lactiflora (~15-30g)
Intervention Type
Device
Intervention Name(s)
Tangerine Peel
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Tangerine Peel (~10g)
Intervention Type
Drug
Intervention Name(s)
Ledebouriella Root
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Ledebouriella Root (~10g)
Intervention Type
Drug
Intervention Name(s)
Radix codonopsitis
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Radix codonopsitis (~10-15g)
Intervention Type
Drug
Intervention Name(s)
Radix curcumae
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Radix curcumae (~10g)
Intervention Type
Drug
Intervention Name(s)
Fingered citron
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Fingered citron (~10g)
Intervention Type
Drug
Intervention Name(s)
Tuckahoe
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Tuckahoe (15g)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is blindly given to patients.
Primary Outcome Measure Information:
Title
The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs
Description
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.
Secondary Outcome Measure Information:
Title
The side effect associated with the treatments
Description
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.
10. Eligibility
Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Jun Xiao, Ph.D.
Organizational Affiliation
University of Minnesota
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210017
Country
China
Facility Name
Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
City
Shanghai
ZIP/Postal Code
200240
Country
China
12. IPD Sharing Statement
Citations:
PubMed Identifier
30219477
Citation
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.
Results Reference
derived
PubMed Identifier
28634136
Citation
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.
Results Reference
derived
PubMed Identifier
25632806
Citation
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.
Results Reference
derived
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A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
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