Condition category
Digestive System
Date applied
19/03/2015
Date assigned
08/04/2015
Last edited
08/04/2015
Prospective/Retrospective
Prospectively registered
Overall trial status
Completed
Recruitment status
No longer recruiting

Plain English Summary

Background and study aims.
Diarrhoea-predominant irritable bowel syndrome (IBS-D) affects around 3% of the population and is characterised by abdominal pain and frequent loose bowel movements. There are few treatments for these symptoms that work and this study aims to see whether Jianpi Shugan recipe might help those with IBS-D. Previous studies have suggested a benefit but this needs to be confirmed.

Who can participate?
Patients diagnosed by their doctors as having diarrhoea-predominant irritable bowel syndrome .

What does the study involve?
Patients will be randomly allocated either to take Jianpi Shugan recipe herbal granules with a placebo (dummy) tablet, or to take Pinaverium with placebo granules for 4 weeks. At the beginning of the study, an examination of the lower bowel will be made and a small specimen taken from the lining (biopsy). This procedure is routinely performed to identify the different causes of diarrhoea.

What are the possible benefits and risks of participating?
We are hoping that towards the end of the 4-week period diarrhoea and abdominal pain will improve. The drugs has been used for many years and the side effects are well recognised. Only a very few will not tolerate the drug because of abdominal discomfort, constipation, diarrhoea, nausea, rash etc.

Where is the study run from?
Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing Chaoyang Hospital affiliated to Capital Medical University
The First Affiliated Hospital of Henan University of TCM
First Teaching Hospital of Tianjin University of TCM
Second Affiliated Hospital of Tianjin University of TCM

When is the study starting and how long is it expected to run for?
From April 2015 and to March 2016.

Who is funding the study?
Beijing municipal administration of hospitals (China).

Who is the main contact?
Dr Shengsheng Zhang
zhss2000@163.com

Trial website

Contact information

Type

Scientific

Primary contact

Dr Luqing Zhao

ORCID ID

http://orcid.org/0000-0003-1986-3511

Contact details

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University
No. 23 Meishuguan Back Street
Dongcheng District
Beijing
100010
China

Additional identifiers

EudraCT number

ClinicalTrials.gov number

Protocol/serial number

N/A

Study information

Scientific title

Efficacy of Jianpi Shugan recipe in the treatment of diarrhoea-predominant irritable bowel syndrome (IBS-D): a multicentre parallel-group randomised controlled trial

Acronym

Study hypothesis

The purpose of the trial is to define the clinical benefit of Jianpi Shugan recipe in diarrhoea-predominant irritable bowel syndrome (IBS-D) . The primary endpoint is to assess the effect of Jianpi Shugan recipe on IBS Symptom Severity Score (IBS-SSS).

Ethics approval

Ethics committee of Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University, 15/02/2015, NO.2015BL-008-02

Study design

Multicentre parallel-group double-blind randomised controlled trial

Primary study design

Interventional

Secondary study design

Randomised parallel trial

Trial setting

Hospitals

Trial type

Treatment

Patient information sheet

Condition

Diarrhoea-predominant irritable bowel syndrome (IBS-D)

Intervention

Patients will be randomized to receive either Jianpi Shugan recipe herbal granules + matching Pinaverium placebo or Pinaverium + matching Jianpi Shugan recipe herbal placebo granules for 4 weeks. Herbal granules were dissolved in 300 ml of boiled water, 150 ml twice daily, Pinaverium 50 mg three times a day.

Intervention type

Drug

Phase

Not Applicable

Drug names

Pinaverium

Primary outcome measures

IBS Symptom Severity Score (IBS-SSS) measured at baseline, 2 weeks and 4 weeks

Secondary outcome measures

1. Traditional Chinese Medicine syndromes of IBS score measured at baseline, 2 weeks and 4 weeks
2. Defection state questionnaire (DSQ) for IBS noted by patients daily
3. Irritable bowel syndrome-quality of life questionnaire (IBS-QOL) at baseline and 4 weeks
4. Serum concentration of serotonin at baseline and 4 weeks

Overall trial start date

01/04/2015

Overall trial end date

31/03/2016

Reason abandoned

Eligibility

Participant inclusion criteria

1. Patients with IBS-D meeting the Rome III criteria
2. Patients meeting the Traditional Chinese Medicine syndrome of liver-depression and spleen-deficiency criteria
3. Patients able to give informed consent
4. Female patients of childbearing potential are willing to use at least one highly effective contraceptive method
5. Aged 18-65 years, either sex

Participant type

Patient

Age group

Adult

Gender

Both

Target number of participants

260

Participant exclusion criteria

1. Women who are pregnant or breastfeeding
2. Prior abdominal surgery which may cause bowel symptoms similar to IBS
3. Patients with the following diarrhea conditions: infection, systemic diseases, poisoning or cancer
4. Patients with serious concomitant diseases e.g. cardiovascular, renal, hepatic, respiratory, neurological, endocrine, hematopoietic etc
5. Patients with a history of alcoholic or drug abuse
6. Patients who have allergic constitution or known to be allergic to the drug used in this trial
7. Patients who are involved in other trials
8. Patients with poor compliance or other reasons that the researcher considered not to be appropriate to participate in this trial

Recruitment start date

01/06/2015

Recruitment end date

01/03/2016

Locations

Countries of recruitment

China

Trial participating centre

Beijing Hospital of Traditional Chinese Medicine affiliated to Capital Medical University
Beijing
100010
China

Trial participating centre

Beijing Chaoyang Hospital affiliated to Capital Medical University
Beijing
China

Trial participating centre

The First Affiliated Hospital of Henan University of TCM
Zhengzhou
China

Trial participating centre

First Teaching Hospital of Tianjin University of TCM
Tianjin
China

Trial participating centre

Second Affiliated Hospital of Tianjin University of TCM
Tianjin
China

Sponsor information

Organisation

Beijing Hospital of Traditional Chinese Medicine Affiliated to Capital Medical University

Sponsor details

No. 23 Meishuguan Back Street
Dongcheng District
Beijing
100010
China

Sponsor type

Hospital/treatment centre

Website

Funders

Funder type

Hospital/treatment centre

Funder name

Beijing municipal administration of hospitals

Alternative name(s)

Funding Body Type

Funding Body Subtype

Location

Results and Publications

Publication and dissemination plan

To be confirmed at a later date

Intention to publish date

Participant level data

Available on request

Results - basic reporting

Publication summary

Publication citations

Additional files

Editorial Notes