A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome

University of Minnesota800 enrolled

Overview

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.

Study Type

INTERVENTIONAL

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Enrollment

800

Conditions

Irritable Bowel Syndrome

Interventions

PinaveriumDRUG

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.

AtractylodesDEVICE

Atractylodes (\~10-15g)

Paeonia LactifloraDEVICE

Paeonia Lactiflora (\~15-30g)

Tangerine PeelDEVICE

Tangerine Peel (\~10g)

Ledebouriella RootDRUG

Ledebouriella Root (\~10g)

Radix codonopsitisDRUG

Radix codonopsitis (\~10-15g)

Radix curcumaeDRUG

Radix curcumae (\~10g)

Fingered citronDRUG

Fingered citron (\~10g)

TuckahoeDRUG

Tuckahoe (15g)

PlaceboDRUG

Placebo is blindly given to patients.

Eligibility

Sex: ALLMin age: 18 YearsMax age: 70 Years

Medical Language ↔ Plain English

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

Locations (4)

Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, China

Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.

Beijing, China

Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University

Shanghai, China

Outcomes

Primary Outcomes

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)

Time frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.

Secondary Outcomes

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.

Time frame: TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.