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

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.

Conditions

• Irritable Bowel Syndrome

Interventions

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)

DEVICE

Paeonia Lactiflora

Paeonia Lactiflora (\~15-30g)

DEVICE

Tangerine Peel

Tangerine Peel (\~10g)

DRUG

Ledebouriella Root

Ledebouriella Root (\~10g)

DRUG

Radix codonopsitis

Radix codonopsitis (\~10-15g)

DRUG

Radix curcumae

Radix curcumae (\~10g)

DRUG

Fingered citron

Fingered citron (\~10g)

DRUG

Tuckahoe

Tuckahoe (15g)

DRUG

Placebo

Placebo is blindly given to patients.

Sponsors & Collaborators

• Macrohard Institute of Health

  lead OTHER

Principal Investigators

• Baiwen Li, MD · Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.

Study Design

Allocation

RANDOMIZED

Purpose

TREATMENT

Masking

DOUBLE

Model

PARALLEL

Eligibility

Min Age

18 Years

Max Age

70 Years

Sex

ALL

Healthy Volunteers

No

Timeline & Regulatory

Start

2012-08-31

Primary Completion

2014-11-30

Completion

2017-05-31

Countries

• China

Study Locations