Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)

Macrohard Institute of Health

Status

Unknown

Conditions

Irritable Bowel Syndrome

Treatments

Drug: Ledebouriella Root

Device: Paeonia Lactiflora

Device: Tangerine Peel

Drug: Radix codonopsitis

Drug: Radix curcumae

Device: Atractylodes

Drug: Fingered citron

Drug: Placebo

Drug: Pinaverium

Drug: Tuckahoe

Study type

Interventional

Funder types

Other

Identifiers

NCT02330029

D00320141210

Details and patient eligibility

About

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.

Full 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.

Enrollment

800 estimated patients

Sex

All

Ages

18 to 70 years old

Volunteers

No Healthy Volunteers

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

Trial design

Primary purpose

Treatment

Allocation

Randomized

Interventional model

Parallel Assignment

Masking

Double Blind

800 participants in 3 patient groups, including a placebo group

TCM (Traditional Chinese medicine)

Active Comparator group

Description:

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.

Treatment: