Overview

This trial is active, not recruiting.

Condition irritable bowel syndrome
Treatments pinaverium, atractylodes, paeonia lactiflora, tangerine peel, ledebouriella root, radix codonopsitis, radix curcumae, fingered citron, tuckahoe, placebo
Sponsor Macrohard Institute of Health
Start date August 2012
End date November 2014
Trial size 800 participants
Trial identifier NCT02330029, D00320141210

Summary

The purpose of this study is to test the onset of action, offset of action, efficacy, and safety of pinaverium and an herbal medication for irritable bowel syndrome (IBS) for a long term (over one year). 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 with no significant different onset and offset of actions when tested by modern clinical standards and criteria.

United States No locations recruiting
Other Countries No locations recruiting

Study Design

Allocation randomized
Endpoint classification safety/efficacy study
Intervention model parallel assignment
Masking double blind (subject, investigator)
Primary purpose treatment
Arm
(Active Comparator)
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.
atractylodes One of active ingredients in TCM group
Atractylodes (~10-15g)
paeonia lactiflora One of active ingredients in TCM group
Paeonia Lactiflora (~15-30g)
tangerine peel One of active ingredients in TCM group
Tangerine Peel (~10g)
ledebouriella root One of active ingredients in TCM group
Ledebouriella Root (~10g)
radix codonopsitis One of active ingredients in TCM group
Radix codonopsitis (~10-15g)
radix curcumae One of active ingredients in TCM group
Radix curcumae (~10g)
fingered citron One of active ingredients in TCM group
Fingered citron (~10g)
tuckahoe One of active ingredients in TCM group
Tuckahoe (15g)
(Active Comparator)
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.
(Placebo Comparator)
Placebo is blindly given to patients
placebo
Placebo is blindly given to patients.

Primary Outcomes

Measure
Abdominal pain
time frame: 2 years
Primary endpoint --- vi) Form (appearance) of stool
time frame: 2 years

Secondary Outcomes

Measure
Frequency of the pain
time frame: 2 year
# of stools per day
time frame: 2 years
Abdominal discomfort
time frame: 2 years
Frequency of discomfort
time frame: 2 years

Eligibility Criteria

Male or female participants from 18 years up to 70 years old.

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

Additional Information

Official title A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Principal investigator Baiwen Li, MD
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. Effectiveness, onset and offset of actions are the most considered factors when physicians choose medications for IBS. Yet, to our knowledge, there are no clinical studies studied the onset and offset of actions of pinaverium, which remains one of the most transcribed IBS medications, and herbs, which are becoming more popular for treating IBS. This study is designed to evaluate onset and offset of actions, efficacy, and safety over a long term (>1 year) 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.
Trial information was received from ClinicalTrials.gov and was last updated in November 2016.
Information provided to ClinicalTrials.gov by Macrohard Institute of Health.