Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
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.
Not provided
Not provided
Not provided
Not provided
| Label | Type | Description | Intervention Names |
|---|---|---|---|
| TCM (Traditional Chinese medicine) | Active Comparator | 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. |
|
| Pinaverium | Active Comparator |
| |
| Placebo | Placebo Comparator | Placebo is blindly given to patients |
|
| Name | Type | Description | Arm Group Labels | Other Names |
|---|---|---|---|---|
| Pinaverium | Drug | 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. |
| Measure | Description | Time Frame |
|---|---|---|
| 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) | TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks. |
| Measure | Description | Time Frame |
|---|---|---|
| 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. | TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks. |
Not provided
Inclusion Criteria:
Exclusion Criteria:
Not provided
Not provided
Not provided
Not provided
Not provided
| Name | Affiliation | Role |
|---|---|---|
| Jun Xiao, Ph.D. | University of Minnesota | Principal Investigator |
| Facility | Status | City | State | ZIP | Country | Contacts |
|---|---|---|---|---|---|---|
| Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine | Nanjing | Jiangsu | 210017 | China |
| PubMed Identifier | Type | Citation | Retractions |
|---|---|---|---|
| 30219477 | Derived | 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. | |
| 28634136 |
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
Not provided
| Atractylodes | Device | Atractylodes (~10-15g) |
|
|
| Paeonia Lactiflora | Device | Paeonia Lactiflora (~15-30g) |
|
|
| Tangerine Peel | Device | Tangerine Peel (~10g) |
|
|
| Ledebouriella Root | Drug | Ledebouriella Root (~10g) |
|
|
| Radix codonopsitis | Drug | Radix codonopsitis (~10-15g) |
|
|
| Radix curcumae | Drug | Radix curcumae (~10g) |
|
|
| Fingered citron | Drug | Fingered citron (~10g) |
|
|
| Tuckahoe | Drug | Tuckahoe (15g) |
|
|
| Placebo | Drug | Placebo is blindly given to patients. |
|
| Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine | Nanjing | Jiangsu | 210029 | China |
| Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University. | Beijing | 100050 | China |
| Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University | Shanghai | 200240 | China |
| Derived |
| 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. |
| 25632806 | Derived | 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. |
| ID | Term |
|---|---|
| D043183 | Irritable Bowel Syndrome |
| D003967 | Diarrhea |
| ID | Term |
|---|---|
| D003109 | Colonic Diseases, Functional |
| D003108 | Colonic Diseases |
| D007410 | Intestinal Diseases |
| D005767 | Gastrointestinal Diseases |
| D004066 | Digestive System Diseases |
| D012817 | Signs and Symptoms, Digestive |
| D012816 | Signs and Symptoms |
| D013568 | Pathological Conditions, Signs and Symptoms |
Not provided
Not provided
| ID | Term |
|---|---|
| C013199 | pinaverium |
| C585952 | diterpenoid C, Radix curcumae |
Not provided
Not provided
Not provided