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

November 18, 2016 updated by: Macrohard Institute of Health

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

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.

Study Overview

Status

Unknown

Conditions

Intervention / Treatment

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.

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.

Study Type

Interventional

Enrollment (Anticipated)

800

Phase

  • Not Applicable

Contacts and Locations

This section provides the contact details for those conducting the study, and information on where this study is being conducted.

Study Locations

  • China
      • Beijing, China, 100050
        • Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
      • Shanghai, China, 200240
        • Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
    • Jiangsu
      • Nanjing, Jiangsu, China, 210017
        • Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
      • Nanjing, Jiangsu, China, 210029
        • Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

Participation Criteria

Researchers look for people who fit a certain description, called eligibility criteria. Some examples of these criteria are a person's general health condition or prior treatments.

Eligibility Criteria

Ages Eligible for Study

18 years to 70 years (Adult, Older Adult)

Accepts Healthy Volunteers

No

Genders Eligible for Study

All

Description

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 Plan

This section provides details of the study plan, including how the study is designed and what the study is measuring.

How is the study designed?

Design Details

  • Primary Purpose: Treatment
  • Allocation: Randomized
  • Interventional Model: Parallel Assignment
  • Masking: Double

Arms and Interventions

Participant Group / Arm
Intervention / Treatment
Active Comparator: TCM (Traditional Chinese medicine)
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.
Device: Atractylodes
Atractylodes (~10-15g)
Other Names:
  • One of active ingredients in TCM group
Device: Paeonia Lactiflora
Paeonia Lactiflora (~15-30g)
Other Names:
  • One of active ingredients in TCM group
Device: Tangerine Peel
Tangerine Peel (~10g)
Other Names:
  • One of active ingredients in TCM group
Drug: Ledebouriella Root
Ledebouriella Root (~10g)
Other Names:
  • One of active ingredients in TCM group
Drug: Radix codonopsitis
Radix codonopsitis (~10-15g)
Other Names:
  • One of active ingredients in TCM group
Drug: Radix curcumae
Radix curcumae (~10g)
Other Names:
  • One of active ingredients in TCM group
Drug: Fingered citron
Fingered citron (~10g)
Other Names:
  • One of active ingredients in TCM group
Drug: Tuckahoe
Tuckahoe (15g)
Other Names:
  • One of active ingredients in TCM group
Active Comparator: Pinaverium
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.
Placebo Comparator: Placebo
Placebo is blindly given to patients
Drug: Placebo
Placebo is blindly given to patients.

What is the study measuring?

Primary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Abdominal pain
Time Frame: 2 years
0 = no pain, 10 worst pain
2 years
Primary endpoint --- vi) Form (appearance) of stool
Time Frame: 2 years
Use Bristol stool scale.
2 years

Secondary Outcome Measures

Outcome Measure
Measure Description
Time Frame
Frequency of the pain
Time Frame: 2 year
0 = no pain; 1 = 1 pain/day; 2 = 2 pains/day; 3 = 3 pains/day; ................... 9 = 9 pains/day; 10 = ≥ 10 pains/day.
2 year
# of stools per day
Time Frame: 2 years
0 = no stool; 1 = 1 stool/day; 2 = 2 stools/day; 3 = 3 stools/day; ............... 9 = 9 stools/day; 10 = ≥ 10 stools/day.
2 years
Abdominal discomfort
Time Frame: 2 years
0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort
2 years
Frequency of discomfort
Time Frame: 2 years
0 = no discomfort; 1 = 1 discomfort/day; 2 = 2 discomforts/day; 3 = 3 discomforts /day; ................... 9 = 9 discomforts/day; 10 = ≥ 10 discomforts/day.
2 years

Other Outcome Measures

Outcome Measure
Measure Description
Time Frame
IBS global symptom relief
Time Frame: 2 years
IBS global symptom relief was evaluated by each patient at the end of the therapy as "improved", "stayed the same", or "worsened"
2 years
Treatment-emergent adverse effect (TEAE) profiles.
Time Frame: 2 years
2 years

Collaborators and Investigators

This is where you will find people and organizations involved with this study.

Sponsor

Macrohard Institute of Health

Investigators

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

Publications and helpful links

The person responsible for entering information about the study voluntarily provides these publications. These may be about anything related to the study.

General Publications

Study record dates

These dates track the progress of study record and summary results submissions to ClinicalTrials.gov. Study records and reported results are reviewed by the National Library of Medicine (NLM) to make sure they meet specific quality control standards before being posted on the public website.

Study Major Dates

Study Start

August 1, 2012

Primary Completion (Actual)

November 1, 2014

Study Completion (Anticipated)

May 1, 2017

Study Registration Dates

First Submitted

December 29, 2014

First Submitted That Met QC Criteria

December 30, 2014

First Posted (Estimate)

January 1, 2015

Study Record Updates

Last Update Posted (Estimate)

November 22, 2016

Last Update Submitted That Met QC Criteria

November 18, 2016

Last Verified

November 1, 2016

More Information

Terms related to this study

Keywords

Additional Relevant MeSH Terms

Other Study ID Numbers

  • D00320141210

This information was retrieved directly from the website clinicaltrials.gov without any changes. If you have any requests to change, remove or update your study details, please contact register@clinicaltrials.gov. As soon as a change is implemented on clinicaltrials.gov, this will be updated automatically on our website as well.

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