MedDataX Logo

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

NCT ID: NCT02330029

Last Updated: 2016-11-22

Study Results

Results pending

The study team has not published outcome measurements, participant flow, or safety data for this trial yet. Check back later for updates.

Basic Information

Get a concise snapshot of the trial, including recruitment status, study phase, enrollment targets, and key timeline milestones.

Recruitment Status

UNKNOWN

Clinical Phase

NA

Total Enrollment

800 participants

Study Classification

INTERVENTIONAL

Study Start Date

2012-08-31

Study Completion Date

2017-05-31

Brief Summary

Review the sponsor-provided synopsis that highlights what the study is about and why it is being conducted.

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

Dive into the extended narrative that explains the scientific background, objectives, and procedures in greater depth.

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.

Conditions

See the medical conditions and disease areas that this research is targeting or investigating.

Irritable Bowel Syndrome

Keywords

Explore important study keywords that can help with search, categorization, and topic discovery.

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

Study Design

Understand how the trial is structured, including allocation methods, masking strategies, primary purpose, and other design elements.

Allocation Method

RANDOMIZED

Intervention Model

PARALLEL

Primary Study Purpose

TREATMENT

Blinding Strategy

DOUBLE

Participants Investigators

Study Groups

Review each arm or cohort in the study, along with the interventions and objectives associated with them.

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.

Group Type ACTIVE_COMPARATOR

Atractylodes

Intervention Type DEVICE

Atractylodes (\~10-15g)

Paeonia Lactiflora

Intervention Type DEVICE

Paeonia Lactiflora (\~15-30g)

Tangerine Peel

Intervention Type DEVICE

Tangerine Peel (\~10g)

Ledebouriella Root

Intervention Type DRUG

Ledebouriella Root (\~10g)

Radix codonopsitis

Intervention Type DRUG

Radix codonopsitis (\~10-15g)

Radix curcumae

Intervention Type DRUG

Radix curcumae (\~10g)

Fingered citron

Intervention Type DRUG

Fingered citron (\~10g)

Tuckahoe

Intervention Type DRUG

Tuckahoe (15g)

Pinaverium

Group Type ACTIVE_COMPARATOR

Pinaverium

Intervention Type DRUG

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

Placebo is blindly given to patients

Group Type PLACEBO_COMPARATOR

Placebo

Intervention Type DRUG

Placebo is blindly given to patients.

Interventions

Learn about the drugs, procedures, or behavioral strategies being tested and how they are applied within this trial.

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.

Intervention Type DRUG

Atractylodes

Atractylodes (\~10-15g)

Intervention Type DEVICE

Paeonia Lactiflora

Paeonia Lactiflora (\~15-30g)

Intervention Type DEVICE

Tangerine Peel

Tangerine Peel (\~10g)

Intervention Type DEVICE

Ledebouriella Root

Ledebouriella Root (\~10g)

Intervention Type DRUG

Radix codonopsitis

Radix codonopsitis (\~10-15g)

Intervention Type DRUG

Radix curcumae

Radix curcumae (\~10g)

Intervention Type DRUG

Fingered citron

Fingered citron (\~10g)

Intervention Type DRUG

Tuckahoe

Tuckahoe (15g)

Intervention Type DRUG

Placebo

Placebo is blindly given to patients.

Intervention Type DRUG

Other Intervention Names

Discover alternative or legacy names that may be used to describe the listed interventions across different sources.

One of active ingredients in TCM group One of active ingredients in TCM group One of active ingredients in TCM group One of active ingredients in TCM group One of active ingredients in TCM group One of active ingredients in TCM group One of active ingredients in TCM group One of active ingredients in TCM group

Eligibility Criteria

Check the participation requirements, including inclusion and exclusion rules, age limits, and whether healthy volunteers are accepted.

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
Minimum Eligible Age

18 Years

Maximum Eligible Age

70 Years

Eligible Sex

ALL

Accepts Healthy Volunteers

No

Sponsors

Meet the organizations funding or collaborating on the study and learn about their roles.

Macrohard Institute of Health

OTHER

Sponsor Role lead

Responsible Party

Identify the individual or organization who holds primary responsibility for the study information submitted to regulators.

Responsibility Role SPONSOR

Principal Investigators

Learn about the lead researchers overseeing the trial and their institutional affiliations.

Baiwen Li, MD

Role: PRINCIPAL_INVESTIGATOR

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

Locations

Explore where the study is taking place and check the recruitment status at each participating site.

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

Nanjing, Jiangsu, China

Site Status

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

Nanjing, Jiangsu, China

Site Status

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

Beijing, , China

Site Status

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

Shanghai, , China

Site Status

Countries

Review the countries where the study has at least one active or historical site.

China

References

Explore related publications, articles, or registry entries linked to this study.

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.

Reference Type DERIVED
PMID: 34230526 (View on PubMed)

Other Identifiers

Review additional registry numbers or institutional identifiers associated with this trial.

D00320141210

Identifier Type: -

Identifier Source: org_study_id