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

Irritable Bowel Syndrome Clinical Trial

Official title:

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

Clinical Trial Details — Status: Active, not recruiting

Administrative data

• NCT number: NCT01641224
• Other study ID #: 1106E00524
• Status: Active, not recruiting
• Phase: N/A
• First received: May 23, 2012
• Last updated: May 9, 2014
• Start date: May 2012
• Est. completion date: May 2014

Study information

• Verified date: May 2014
• Source: University of Minnesota - Clinical and Translational Science Institute
• Contact: n/a
• Is FDA regulated: No
• Health authority: United States: Institutional Review BoardChina: Food and Drug Administration
• Study type: Interventional

Clinical Trial 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.

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.

Recruitment information / eligibility

• Status: Active, not recruiting
• Enrollment: 800
• Est. completion date: May 2014
• Est. primary completion date: May 2013
• Accepts healthy volunteers: No
• Gender: Both
• Age group: 18 Years to 70 Years

Eligibility

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

Study Design

Allocation: Randomized, Endpoint Classification: Safety/Efficacy Study, Intervention Model: Parallel Assignment, Masking: Double Blind (Subject, Investigator), Primary Purpose: Treatment

Related Conditions & MeSH terms

• Irritable Bowel Syndrome
• Syndrome

Intervention

Drug:
• Pinaverium
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.

Device:
• Atractylodes
Atractylodes (~10-15g)
• Paeonia Lactiflora
Paeonia Lactiflora (~15-30g)
• Tangerine Peel
Tangerine Peel (~10g)

Drug:
• Ledebouriella Root
Ledebouriella Root (~10g)
• Radix codonopsitis
Radix codonopsitis (~10-15g)
• Radix curcumae
Radix curcumae (~10g)
• Fingered citron
Fingered citron (~10g)
• Tuckahoe
Tuckahoe (15g)
• Placebo
Placebo is blindly given to patients.

Locations

Country	Name	City	State
China	Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.	Beijing
China	Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine	Nanjing	Jiangsu
China	Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University	Shanghai

Sponsors (1)

Lead Sponsor	Collaborator
University of Minnesota - Clinical and Translational Science Institute

Country where clinical trial is conducted

China, 

Outcome

Type	Measure	Description	Time frame	Safety issue
Primary	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.	No
Secondary	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.	No