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

Primary Purpose

Irritable Bowel Syndrome

Status
Unknown status
Phase
Not Applicable
Locations
China
Study Type
Interventional
Intervention
Pinaverium
Atractylodes
Paeonia Lactiflora
Tangerine Peel
Ledebouriella Root
Radix codonopsitis
Radix curcumae
Fingered citron
Tuckahoe
Placebo
Sponsored by
Macrohard Institute of Health
About
Eligibility
Locations
Arms
Outcomes
Full info

About this trial

This is an interventional treatment trial for Irritable Bowel Syndrome focused on measuring Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)

Eligibility Criteria

18 Years - 70 Years (Adult, Older Adult)All SexesDoes not accept 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

Sites / Locations

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

Arms of the Study

Arm 1

Arm 2

Arm 3

Arm Type

Active Comparator

Active Comparator

Placebo Comparator

Arm Label

TCM (Traditional Chinese medicine)

Pinaverium

Placebo

Arm 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.

Placebo is blindly given to patients

Outcomes

Primary Outcome Measures

Abdominal pain
0 = no pain, 10 worst pain
Primary endpoint --- vi) Form (appearance) of stool
Use Bristol stool scale.

Secondary Outcome Measures

Frequency of the pain
0 = no pain; 1 = 1 pain/day; 2 = 2 pains/day; 3 = 3 pains/day; ................... 9 = 9 pains/day; 10 = ≥ 10 pains/day.
# of stools per day
0 = no stool; 1 = 1 stool/day; 2 = 2 stools/day; 3 = 3 stools/day; ............... 9 = 9 stools/day; 10 = ≥ 10 stools/day.
Abdominal discomfort
0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort
Frequency of discomfort
0 = no discomfort; 1 = 1 discomfort/day; 2 = 2 discomforts/day; 3 = 3 discomforts /day; ................... 9 = 9 discomforts/day; 10 = ≥ 10 discomforts/day.

Full Information

First Posted
December 29, 2014
Last Updated
November 18, 2016
Sponsor
Macrohard Institute of Health
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1. Study Identification

Unique Protocol Identification Number
NCT02330029
Brief Title
Pinaverium and Herbs for Irritable Bowel Syndrome Treatment: an Onset and Offset Study (PHIBEST)
Official Title
A Randomized, Double-blind, and Placebo-controlled Study on the Treatments of Irritable Bowel Syndrome
Study Type
Interventional

2. Study Status

Record Verification Date
November 2016
Overall Recruitment Status
Unknown status
Study Start Date
August 2012 (undefined)
Primary Completion Date
November 2014 (Actual)
Study Completion Date
May 2017 (Anticipated)

3. Sponsor/Collaborators

Responsible Party, by Official Title
Sponsor
Name of the Sponsor
Macrohard Institute of Health

4. Oversight

Data Monitoring Committee
Yes

5. Study Description

Brief 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.
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.

6. Conditions and Keywords

Primary Disease or Condition Being Studied in the Trial, or the Focus of the Study
Irritable Bowel Syndrome
Keywords
Irritable bowel syndrome,, Pinaverium, Herbal medication for IBS,, Tong Xie Yao Fang (Formula for pain and diarrhea)

7. Study Design

Primary Purpose
Treatment
Study Phase
Not Applicable
Interventional Study Model
Parallel Assignment
Masking
ParticipantInvestigator
Allocation
Randomized
Enrollment
800 (Anticipated)

8. Arms, Groups, and Interventions

Arm Title
TCM (Traditional Chinese medicine)
Arm Type
Active Comparator
Arm 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.
Arm Title
Pinaverium
Arm Type
Active Comparator
Arm Title
Placebo
Arm Type
Placebo Comparator
Arm Description
Placebo is blindly given to patients
Intervention Type
Drug
Intervention Name(s)
Pinaverium
Intervention Description
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.
Intervention Type
Device
Intervention Name(s)
Atractylodes
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Atractylodes (~10-15g)
Intervention Type
Device
Intervention Name(s)
Paeonia Lactiflora
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Paeonia Lactiflora (~15-30g)
Intervention Type
Device
Intervention Name(s)
Tangerine Peel
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Tangerine Peel (~10g)
Intervention Type
Drug
Intervention Name(s)
Ledebouriella Root
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Ledebouriella Root (~10g)
Intervention Type
Drug
Intervention Name(s)
Radix codonopsitis
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Radix codonopsitis (~10-15g)
Intervention Type
Drug
Intervention Name(s)
Radix curcumae
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Radix curcumae (~10g)
Intervention Type
Drug
Intervention Name(s)
Fingered citron
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Fingered citron (~10g)
Intervention Type
Drug
Intervention Name(s)
Tuckahoe
Other Intervention Name(s)
One of active ingredients in TCM group
Intervention Description
Tuckahoe (15g)
Intervention Type
Drug
Intervention Name(s)
Placebo
Intervention Description
Placebo is blindly given to patients.
Primary Outcome Measure Information:
Title
Abdominal pain
Description
0 = no pain, 10 worst pain
Time Frame
2 years
Title
Primary endpoint --- vi) Form (appearance) of stool
Description
Use Bristol stool scale.
Time Frame
2 years
Secondary Outcome Measure Information:
Title
Frequency of the pain
Description
0 = no pain; 1 = 1 pain/day; 2 = 2 pains/day; 3 = 3 pains/day; ................... 9 = 9 pains/day; 10 = ≥ 10 pains/day.
Time Frame
2 year
Title
# of stools per day
Description
0 = no stool; 1 = 1 stool/day; 2 = 2 stools/day; 3 = 3 stools/day; ............... 9 = 9 stools/day; 10 = ≥ 10 stools/day.
Time Frame
2 years
Title
Abdominal discomfort
Description
0 = no discomfort...... 10 = Worst possible, unbearable unbearable discomfort
Time Frame
2 years
Title
Frequency of discomfort
Description
0 = no discomfort; 1 = 1 discomfort/day; 2 = 2 discomforts/day; 3 = 3 discomforts /day; ................... 9 = 9 discomforts/day; 10 = ≥ 10 discomforts/day.
Time Frame
2 years
Other Pre-specified Outcome Measures:
Title
IBS global symptom relief
Description
IBS global symptom relief was evaluated by each patient at the end of the therapy as "improved", "stayed the same", or "worsened"
Time Frame
2 years
Title
Treatment-emergent adverse effect (TEAE) profiles.
Time Frame
2 years

10. Eligibility

Sex
All
Minimum Age & Unit of Time
18 Years
Maximum Age & Unit of Time
70 Years
Accepts Healthy Volunteers
No
Eligibility Criteria
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
Overall Study Officials:
First Name & Middle Initial & Last Name & Degree
Baiwen Li, MD
Organizational Affiliation
Department of Gastroenterology, Shanghai First People's Hospital, Shanghai Jiao Tong University, 100 Haining Rd. Hongkou, Shanghai 200280, China.
Official's Role
Principal Investigator
Facility Information:
Facility Name
Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210017
Country
China
Facility Name
Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine
City
Nanjing
State/Province
Jiangsu
ZIP/Postal Code
210029
Country
China
Facility Name
Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.
City
Beijing
ZIP/Postal Code
100050
Country
China
Facility Name
Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University
City
Shanghai
ZIP/Postal Code
200240
Country
China

12. IPD Sharing Statement

Citations:
PubMed Identifier
34230526
Citation
Zheng L, Lu W, Xiao Q, Lai Y, Fan H, Sun Y, Huang D, Wang Y, Li Z, Jiang Z, Liu X, Zhang L, Zuo D, Shou Z, Tang Q, Huang H, Yang Y, Tang Z, Xiao J. Assessing the post-treatment therapeutic effect of pinaverium in irritable bowel syndrome: a randomized controlled trial. Sci Rep. 2021 Jul 6;11(1):13894. doi: 10.1038/s41598-021-92990-7.
Results Reference
derived

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

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