NCT02330029

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.

Trial Health

43
At Risk

Trial Health Score

Automated assessment based on enrollment pace, timeline, and geographic reach

Trial has exceeded expected completion date
Enrollment
800

participants targeted

Target at P75+ for not_applicable

Timeline
Completed

Started Aug 2012

Longer than P75 for not_applicable

Geographic Reach
1 country

4 active sites

Status
unknown

Health score is calculated from publicly available data and should be used for screening purposes only.

Trial Relationships

Click on a node to explore related trials.

Study Timeline

Key milestones and dates

Study Start

First participant enrolled

August 1, 2012

Completed
2.3 years until next milestone

Primary Completion

Last participant's last visit for primary outcome

November 1, 2014

Completed
2 months until next milestone

First Submitted

Initial submission to the registry

December 29, 2014

Completed
3 days until next milestone

First Posted

Study publicly available on registry

January 1, 2015

Completed
2.3 years until next milestone

Study Completion

Last participant's last visit for all outcomes

May 1, 2017

Completed
Last Updated

November 22, 2016

Status Verified

November 1, 2016

Enrollment Period

2.3 years

First QC Date

December 29, 2014

Last Update Submit

November 18, 2016

Conditions

Irritable Bowel Syndrome

Keywords

Irritable bowel syndrome,PinaveriumHerbal medication for IBS,Tong Xie Yao Fang (Formula for pain and diarrhea)

Outcome Measures

Primary Outcomes (2)

  • Abdominal pain

    0 = no pain, 10 worst pain

    2 years

  • Primary endpoint --- vi) Form (appearance) of stool

    Use Bristol stool scale.

    2 years

Secondary Outcomes (4)

  • Frequency of the pain

    2 year

  • # of stools per day

    2 years

  • Abdominal discomfort

    2 years

  • Frequency of discomfort

    2 years

Other Outcomes (2)

  • IBS global symptom relief

    2 years

  • Treatment-emergent adverse effect (TEAE) profiles.

    2 years

Study Arms (3)

TCM (Traditional Chinese medicine)

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.

Device: AtractylodesDevice: Paeonia LactifloraDevice: Tangerine PeelDrug: Ledebouriella RootDrug: Radix codonopsitisDrug: Radix curcumaeDrug: Fingered citronDrug: Tuckahoe

Pinaverium

ACTIVE COMPARATOR
Drug: Pinaverium

Placebo

PLACEBO COMPARATOR

Placebo is blindly given to patients

Drug: Placebo

Interventions

PinaveriumDRUG

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.

Pinaverium
AtractylodesDEVICE

Atractylodes (\~10-15g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
Paeonia LactifloraDEVICE

Paeonia Lactiflora (\~15-30g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
Tangerine PeelDEVICE

Tangerine Peel (\~10g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
Ledebouriella RootDRUG

Ledebouriella Root (\~10g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
Radix codonopsitisDRUG

Radix codonopsitis (\~10-15g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
Radix curcumaeDRUG

Radix curcumae (\~10g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
Fingered citronDRUG

Fingered citron (\~10g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
TuckahoeDRUG

Tuckahoe (15g)

Also known as: One of active ingredients in TCM group
TCM (Traditional Chinese medicine)
PlaceboDRUG

Placebo is blindly given to patients.

Placebo

Eligibility Criteria

Age18 Years - 70 Years
Sexall
Healthy VolunteersNo
Age GroupsAdult (18-64), Older Adult (65+)

You may qualify if:

  • 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

You may not qualify if:

  • 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

Contact the study team to confirm eligibility.

Sponsors & Collaborators

Study Sites (4)

Second Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, 210017, China

Location

Jiangsu Provincial Hospital of Traditional Chinese Medicine affiliated to Nanjing University of Traditional Chinese Medicine

Nanjing, Jiangsu, 210029, China

Location

Beijing Xuanwu Hospital of Traditional Chinese Medicine affiliated to Capital Medical University.

Beijing, 100050, China

Location

Shanghai First People's Hospital affiliated to Shanghai Tiao Tong University

Shanghai, 200240, China

Location

Related Publications (1)

  • 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.

    PMID: 34230526DERIVED

MeSH Terms

Conditions

Irritable Bowel SyndromeDiarrhea

Interventions

pinaveriumditerpenoid C, Radix curcumae

Condition Hierarchy (Ancestors)

Colonic Diseases, FunctionalColonic DiseasesIntestinal DiseasesGastrointestinal DiseasesDigestive System DiseasesSigns and Symptoms, DigestiveSigns and SymptomsPathological Conditions, Signs and Symptoms

Study Officials

  • Baiwen Li, MD

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

    PRINCIPAL INVESTIGATOR

Study Design

Study Type
interventional
Phase
not applicable
Allocation
RANDOMIZED
Masking
DOUBLE
Who Masked
PARTICIPANT, INVESTIGATOR
Purpose
TREATMENT
Intervention Model
PARALLEL
Sponsor Type
OTHER
Responsible Party
SPONSOR

Study Record Dates

First Submitted

December 29, 2014

First Posted

January 1, 2015

Study Start

August 1, 2012

Primary Completion

November 1, 2014

Study Completion

May 1, 2017

Last Updated

November 22, 2016

Record last verified: 2016-11

Locations

CN(4)