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

Not Applicable

• Conditions: Irritable Bowel Syndrome
• Interventions: Device: Atractylodes; Drug: Pinaverium; Drug: Placebo; Device: Paeonia Lactiflora; Device: Tangerine Peel; Drug: Ledebouriella Root; Drug: Radix codonopsitis; Drug: Radix curcumae; Drug: Fingered citron; Drug: Tuckahoe

• Registration Number: NCT01641224
• Lead Sponsor: University of Minnesota

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.

Basic Information
|
Recruitment & Eligibility
|
Study & Design
|
Trial Locations

Study Timeline

• Study Start: 2012-05
• Study First Submitted: 2012-05-23
• Study First Submitted QC: 2012-07-11
• Study First Posted: 2012-07-16
• Primary Completion: 2013-05
• Status Verified: 2014-05
• Study Completion: 2014-05
• Last Update Submitted: 2014-05-09
• Last Update Posted: 2014-05-12

Recruitment & Eligibility

• Status: UNKNOWN
• Sex: All
• Target Recruitment: 800

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

Read More

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

Read More

Study & Design

• Study Type: INTERVENTIONAL
• Study Design: PARALLEL

Arm && Interventions

Group	Intervention	Description
TCM (Traditional Chinese medicine)	Atractylodes	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.
TCM (Traditional Chinese medicine)	Paeonia Lactiflora	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.
TCM (Traditional Chinese medicine)	Tangerine Peel	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.
TCM (Traditional Chinese medicine)	Ledebouriella Root	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.
TCM (Traditional Chinese medicine)	Radix codonopsitis	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.
TCM (Traditional Chinese medicine)	Radix curcumae	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.
TCM (Traditional Chinese medicine)	Fingered citron	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.
TCM (Traditional Chinese medicine)	Tuckahoe	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	Pinaverium	-
Placebo	Placebo	Placebo is blindly given to patients

Primary Outcome Measures

Name	Time	Method
The relief of irritable bowel syndrome symptoms was used to measure the effectiveness of the drugs	TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.	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

Name	Time	Method
The side effect associated with the treatments	TCM group: 4 weeks. Pinaverium: 4 weeks. Placebo: 4 weeks.	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.

Trial Locations

Locations (4)

Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University; 🇨🇳 Shanghai, China

Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.; 🇨🇳 Beijing, China

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