Irritable Bowel Syndrome Clinical Trial
Official title:
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
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.
;
Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment
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