Clinical trial NCT01641224: 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
Overall status: UNKNOWN
Phase: NA
Conditions: Irritable Bowel Syndrome
Keywords: Irritable bowel syndrome,
Pinaverium
Herbal medication for IBS,
Tong Xie Yao Fang (Formula for pain and diarrhea)
Lead sponsor: University of Minnesota
Sponsor class: OTHER
First posted: 2012-07-16
Enrollment: 800
Sex: ALL
Minimum age (years): 18
Maximum age (years): 70
Standard ages: ADULT
OLDER_ADULT
Accepts healthy volunteers: no
Allocation: RANDOMIZED
Intervention model: PARALLEL
Primary purpose: TREATMENT

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.

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

Primary outcomes:
measure: The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs
timeFrame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
Secondary outcomes:
measure: The side effect associated with the treatments
timeFrame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.
Other outcomes:
Locations:
city: Nanjing
country: China
facility: Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
state: Jiangsu
city: Nanjing
country: China
facility: Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
state: Jiangsu
city: Beijing
country: China
facility: Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
city: Shanghai
country: China
facility: Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
Study officials:
affiliation: University of Minnesota
name: Jun Xiao, Ph.D.
role: PRINCIPAL_INVESTIGATOR
References:
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.
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.
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.